RU2826006C1 - Test cassette for analytical instruments - Google Patents

Abstract

FIELD: chemistry.

SUBSTANCE: group of inventions relates to analytical chemistry. Disclosed are test cassettes for insertion into an analytical instrument (embodiments), having a linear actuator, a rotary actuator, a heater, a pump actuator, a second linear actuator and a cartridge receiver and comprising a test cartridge body, a plurality of first linear displacement sensors, a second linear displacement sensor, an angular displacement sensor, a temperature sensor, a plurality of load sensors.

EFFECT: group of inventions provides the ability to test the functionality of one or more interface mechanisms of an analytical instrument cassette and diagnose the problems of these mechanisms without disassembling the analytical instrument and at the same time minimizing the maintenance time and downtime of the analytical instrument.

35 cl, 13 dwg

Description

INCORPORATION BY LINK

[0001] A PCT Request Form is filed concurrently with this specification in this application. Each application for which benefit or priority is claimed in this application as indicated in a concurrently filed PCT Request Form is incorporated herein by reference in its entirety and for all purposes.

PREREQUISITES FOR THE CREATION OF THE INVENTION

[0002] Various analytical instruments, such as genome sequencing systems, may employ a cassette-based framework system in which various elements used during analysis are provided in one or more removable cassettes, such as a flow cell cassette, a reagent cassette, and/or a wash cassette. The analytical instruments may include various systems configured to interact with the analytical cassettes.

SUMMARY OF THE INVENTION

[0003] A detailed description of one or more embodiments of the subject matter of the invention presented in the present description is set forth in the accompanying drawings and description below. Other features, aspects and advantages will be apparent from the description, drawings and claims. The following non-limiting embodiments are considered part of the present description; other embodiments will also be apparent from the description of the present invention and the accompanying drawings.

[0004] The test cassettes may comprise one or more sensors for measuring and determining the functionality of the analytical instrument with respect to the actuator systems for the analytical cassettes. The test cassette may include one or more linear displacement sensors for measuring the linear motion and/or force applied by the linear actuator(s) of the analytical instrument, such as may be used in a punching mechanism, a pump actuator, and/or a valve actuator. Also or alternatively, the test cassette may include an angular displacement sensor or sensors for measuring the angular motion and/or torque caused by the rotary actuator systems of the analytical instrument. In some cases, the test cassette may alternatively or additionally include miniature load cells for measuring the linear force applied by the analytical instrument, and in some cases, a temperature sensor for measuring the performance of the heating element of the analytical instrument.

[0005] These sensors may be located within the test cassettes and may be configured to simulate various functionalities of the systems within the assay cassettes. This may allow the assay device to interact with the test cassette in substantially the same manner as with the assay cassette. For example, the test cassette may have angular displacement sensors with external splined shafts that have at least some of the same external features as the splined shafts of the assay cassette and that are located within the test cassette such that when the test cassette is inserted and positioned in the assay device, these splined shafts are in the same positions relative to the assay device as their counterparts in actual assay cassettes. These angular displacement sensors may also simulate the operation of rotary valves in the assay cassette, including the resistance exerted by such valves on the actuator of the rotary valve of the assay device. Similarly, linear displacement sensors for testing the foil piercing mechanism may have elements similar to those present in the assay cassette, for example, providing contact points for engagement pins in the same locations as on the perforating disk, and may simulate the operation of the assay cassette, including the resistance provided by the foil membrane when pierced by the perforating disk. In some embodiments, additional sensors may also simulate the position and functionality of elements of the assay cassette so that the assay device can interact with multiple aspects of the assay cassette.

[0006] In some embodiments, a test cassette may be provided for insertion into an assay device having a linear actuator, a rotary actuator, a heater, a pump actuator, a second linear actuator, and a cassette receiver. The test cassette may include a test cassette housing having a design type suitable for receiving cassettes of an analytical instrument by a receiver, a plurality of first linear displacement sensors, wherein each first linear displacement sensor has a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a first portion of each of the plurality of first linear displacement sensors is located inside the test cassette housing so that its corresponding first movable element engages with a linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, and wherein each first detector of each of the plurality of first linear displacement sensors is designed to determine a first distance traveled by the corresponding first movable element along the first axis relative to the test cassette housing in response to linear input data provided by the linear actuator of the analytical instrument upon insertion of the cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, a second linear displacement sensor having a second detector and a second a movable element capable of linear movement along a second axis, where at least a second portion of the second linear displacement sensor is located inside the test cassette housing so that the second movable element engages with the analytical instrument pump actuator upon insertion of the test cassette into the analytical instrument and activation of the analytical instrument pump actuator, and where the second detector is designed to determine a second distance traveled by the second movable element along the second axis relative to the test cassette housing upon insertion of the test cassette into the analytical instrument and activation of the analytical instrument pump actuator, an angular displacement sensor having a third detector and a rotary element capable of rotation about a third axis, where the angular displacement sensor is located inside the test cassette housing so that the rotary element engages with the analytical instrument rotary actuator upon insertion of the test cassette into the analytical instrument and activation of the analytical instrument rotary actuator, and where the third detector is designed to determine an angle through which the rotary element rotates about the third axis relative to the test cassette housing upon insertion of the test cassette into the analytical instrument a device and an activation of a rotary actuator of the analytical instrument, a temperature sensor having a receiving portion in the body of the test cassette and a temperature detector located inside the receiving portion, wherein the temperature sensor is located inside the body of the test cassette so that the receiving portion should interact with a heating element of the analytical instrument when the test cassette is inserted into the analytical instrument, and wherein the temperature detector is designed to determine the temperature inside the receiving portion when the test cassette is inserted into the analytical instrument, and a plurality of load sensors, each of the plurality of load sensors is located inside the body of the test cassette so that each load sensor engages with a second linear actuator when the test cassette is inserted into the analytical instrument and the second linear actuator of the analytical instrument is activated, and wherein each of the plurality of load sensors is designed to determine a force applied to the corresponding load sensor when the test cassette is inserted into the analytical instrument and the second linear actuator of the analytical instrument is activated.

[0007] In some embodiments, the test cassette may further include a controller having one or more processors and one or more memory devices, wherein the controller is coupled to communicate with each first detector of each of the plurality of first linear displacement sensors, the second detector of the second linear displacement sensor, the third detector of the angular displacement sensor, the temperature detector of the temperature sensor, and each of the plurality of load sensors, and the controller is configured to receive and store data generated by each first detector, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors.

[0008] In any of the above embodiments, the test cassette may further include a communication interface for transmitting data generated by each of the plurality of first linear displacement sensors, the second linear displacement sensor, the angular displacement sensor, the temperature sensor and the plurality of load sensors to an external device.

[0009] In any of the above embodiments, the external device may be an analytical instrument.

[0010] In any of the above embodiments, the controller may be configured to transmit updated movement data to the analytical device, and the updated movement data may be based at least in part on one or more data generated by one or more of the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors.

[0011] In any of the above embodiments, the controller may be configured to transmit data generated by the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors to the analytical device, and the analytical device may issue a notification based at least in part on the data generated by the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors.

[0012] In any of the above embodiments, each of the plurality of first linear displacement sensors may further include a first resistive element (force application element) for applying a first resistive force to the first movable element along the first axis, and the angular displacement sensor may further include a second resistive element for applying a second resistive force to the rotary element.

[0013] In any of the above embodiments, the angular displacement sensor may further include a friction element for contacting and applying a frictional force to the rotary element, the angular displacement sensor may further include a resistive element arranged such that the friction element is located between the resistive element and the rotary element, and the resistive element may be designed to apply a force to the friction element along the third axis and in a direction toward the rotary element.

[0014] In any of the above embodiments, the test cassette may further include a second angular displacement sensor having a second angular detector and a second rotary member rotating about a second axis of rotation, where the second angular displacement sensor is arranged such that the second rotary member engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated, and where the second angular detector is configured to determine a second angle by which the second rotary member rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated.

[0015] In some embodiments, a test cassette may be provided for insertion into an analytical instrument having a linear actuator and a cassette receiver. The test cassette may include a test cassette housing having a design type suitable for receiving cassettes by the receiver of the analytical instrument, and a plurality of linear displacement sensors, wherein each of the linear displacement sensors has a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a portion of each of the linear displacement sensors is located in the test cassette housing so that its corresponding first movable element engages with the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, and each detector is designed to determine the distance traveled by the corresponding first movable element along the corresponding first axis relative to the test cassette housing upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument.

[0016] In any of the above embodiments, each linear displacement sensor may further include a resistive element for applying a resistive force to the first movable element along the first axis in the first direction.

[0017] In any of the above embodiments, the resistive element may be a compression spring.

[0018] In any of the above embodiments, each linear displacement sensor may further include a contact portion with which the engaging pin of the linear actuator contacts.

[0019] In any of the above embodiments, each movable element may include an encoder strip, and each detector may be an optical sensor for detecting movement of the encoder strip included in the corresponding movable element.

[0020] In any of the above embodiments, the test cassette may further include a controller having one or more processors and one or more memory devices, wherein the controller is coupled with the ability to transmit data to each first detector of each of the one or more linear displacement sensors, and the controller is configured to receive and store data generated by each first detector of each of the linear displacement sensors.

[0021] In any of the above embodiments, the test cassette may further include a communication interface for transmitting data generated by each of the one or more first linear displacement sensors.

[0022] In any of the above embodiments, the communication interface may be configured to transmit data generated by each of the one or more first linear displacement sensors to the analytical instrument, the controller may be configured to transmit calibration data to the analytical instrument, and the calibration data may be based at least in part on data generated by the one or more first linear displacement sensors of the analytical instrument.

[0023] In some embodiments, a test cassette may be provided for insertion into an assay device having a pump actuator and a cassette receiver. The test cassette may include a test cassette housing having a design type suitable for receiving cassettes of the analytical instrument by a receiver, a first opening and a second opening opposite the first opening, wherein the second opening is intended for receiving a part of the actuator of the pump of the analytical instrument, and a linear displacement sensor having a detector and a movable element configured to move linearly along a first axis, wherein at least a part of the movable element is located in the test cassette housing in the test cassette, wherein the movable element is located between the first opening and the second opening, the movable element engages and moves with a part of the actuator of the pump inserted through the second opening, when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated, and when the actuator of the pump moves when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated, the movable element moves through the first opening, and the detector determines the distance traveled by the movable element along the first axis relative to the test cassette housing.

[0024] In any of the above embodiments, the test cassette may further include a controller having one or more processors and one or more memory devices, wherein the controller is communicatively coupled to the linear displacement sensor detector, and the controller is configured to receive and store data generated by the linear displacement sensor detector.

[0025] In any of the above embodiments, the test cassette may further include a communication interface for transmitting data generated by the linear displacement sensor.

[0026] In some embodiments, a test cassette may be provided for insertion into an assay device having a rotary actuator and a cassette receiver. The test cassette may include a test cassette housing having a design type suitable for receiving cassettes of an analytical instrument by a receiver, and a port for receiving a heater of the analytical instrument, a first angular displacement sensor having a first detector and a first rotary element configured to rotate about a first axis of rotation, the first angular displacement sensor is located inside the test cassette housing in such a way that the first rotary element engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the first detector is designed to determine a first angle by which the first rotary element rotates about the first axis of rotation relative to the test cassette housing when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and a temperature sensor having a receiving portion in the test cassette housing and a temperature sensor located inside the receiving portion, wherein the temperature sensor is located inside the test cassette housing in such a way that the receiving portion engages with the heater of the analytical instrument when the test cassette is inserted into an analytical instrument, wherein the receiving part must be heated by the heater of the analytical instrument, and wherein the temperature sensor is intended to determine the temperature inside the receiving part.

[0027] In any of the above embodiments, the test cassette may further include a second angular displacement sensor having a second detector and a second rotary member rotating about a second axis of rotation, where the second angular displacement sensor is located in the body of the test cassette such that the second rotary member engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and where the second detector is configured to determine a second angle by which the second rotary member rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated.

[0028] In any of the above embodiments, the first axis of rotation and the second axis of rotation may be parallel to each other.

[0029] In any of the above embodiments, the rotary member may include a shaft and elements for engaging with the rotary actuator of the analysis device.

[0030] In any of the above embodiments, the first angular displacement sensor may further include an encoder disk having a central axis of the disk that is aligned with the central axis of the rotary member and the first axis, and the first detector may be an optical sensor for detecting the displacement of the encoder disk.

[0031] In any of the above embodiments, the first angular displacement sensor may further include a resistive element for applying a resistive force to the rotary element.

[0032] In any of the above embodiments, the first angular displacement sensor may further include a friction element for contacting and applying a frictional force to the rotary element.

[0033] In any of the above embodiments, the first angular displacement sensor may further include a resistive element arranged such that the friction element is arranged between the resistive element and the first rotary element, and the resistive element may be configured to apply a force to the friction element along the axis of rotation in a direction toward the rotary element.

[0034] In any of the above embodiments, the receiving portion may be made of metal.

[0035] In any of the above embodiments, the receiving portion may contact a heater inserted through the port.

[0036] In any of the above embodiments, the receiving portion may further include a heating sleeve around the receiving portion, and the heating sleeve may contact a heater inserted through the port.

[0037] In any of the above embodiments, the test cassette may further include a torque sensor for measuring the torque applied to the rotary member.

[0038] In any of the above embodiments, the test cassette may further include a controller having one or more processors and one or more memory devices, wherein the controller is communicatively coupled to the first detector and the temperature detector, and the controller is configured to receive and store data generated by the first detector and the temperature detector.

[0039] In any of the above embodiments, the test cassette may further include a communication interface for transmitting data generated by the first angular displacement sensor and the temperature sensor.

[0040] In any of the above embodiments, the communication interface may be configured to transmit data generated by the first angular displacement sensor and the temperature sensor, the controller may be configured to transmit data generated by the first angular displacement sensor and the temperature sensor to the analytical device, and the analytical device may generate a notification based at least in part on the data generated by one or more of the first angular displacement sensor and the temperature sensor.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0041] The various embodiments described herein are shown by way of example and not limitation in the accompanying drawings, in which like reference numerals refer to like elements.

[0042] Fig. 1 shows an embodiment of an analytical device and a removable analytical cassette.

[0043] Fig. 2A shows an outside angle view of an embodiment of the assay cassette, and Fig. 2B shows a partially exploded view of the assay cassette.

[0044] Fig. 2C is an off-angle view of the assay cassette of Fig. 2A with the top portion removed.

[0045] Fig. 3 is an off-angle cross-sectional view of the analytical cassette and rotary valve drive mechanism of the analytical instrument.

[0046] Fig. 4 shows a cross-sectional view of an embodiment of an analytical cassette with a pumping mechanism.

[0047] Fig. 5 shows a cross-sectional view of a portion of an embodiment of an analytical cassette and an actuator system of an analytical instrument valve.

[0048] Fig. 6 is a cross-sectional view of another portion of an embodiment of the assay cassette and heater probe.

[0049] Fig. 7 shows an embodiment of a test cassette with multiple sensors.

[0050] Fig. 8 is a cross-sectional view of the first linear displacement sensor in the test cassette shown in Fig. 7.

[0051] Fig. 9 is a cross-sectional view of a second linear displacement sensor in the test cassette shown in Fig. 7.

[0052] Fig. 10 is a cross-sectional view of the angular displacement sensor in the test cassette shown in Fig. 7.

[0053] Fig. 11 is a cross-sectional view of the temperature sensor in the test cassette shown in Fig. 7.

DETAILED DESCRIPTION

[0054] A test cassette containing one or more sensors can be used to measure and determine the functionality of an assay device in relation to assay cassette actuator systems. As noted above, various assay devices, such as genome sequencing systems, can use a cassette-based framework system in which various elements used during an assay are provided in one or more removable cassettes, such as a flow cell cassette, a reagent cassette, and/or a wash cassette; in some embodiments, all of these elements can be combined into a single assay cassette. In some cases, these assay cassettes can contain consumable elements in various compartments that can be sealed with a perforable foil layer. The assay cassettes can also include, for example, various valves or pumps that can be activated by applying rotational and/or linear inputs.

[0055] These assay devices may include features for preparing the assay cassettes for use, such as movable tabs for piercing the foil, rotary features for rotating one or more valves of the assay cassette, linear reciprocating features for actuating a pumping mechanism that pumps consumables such as reagents through the assay cassette, and valves such as pinch valves that can be used to direct and control the flow through the assay cassette. Some assay devices may also have a heating probe for heating reagents and/or samples within the chamber of the assay cassette. It may be desirable to test the functionality of one or more of the assay device cassette interface mechanisms to ensure proper functionality and to diagnose problems with these mechanisms without disassembling the assay device, thereby minimizing maintenance time and downtime of the assay device.

Presentation of analytical cassettes and analytical instruments

[0056] A brief discussion of embodiments of assay cassettes, assay instruments, and some of their systems and mechanisms is provided in the following sections to provide context for the assay cassettes described below.

[0057] Fig. 1 shows an embodiment of an analytical device and a removable analytical cassette. Fig. 1 shows an analytical device 102 that includes a receiving portion, groove or other interface 103 configured to receive an analytical cassette 104 or a test cassette (not shown), described below, which can be considered a cassette receiver. The analytical device 102 may be configured to receive an analytical cassette 104 (or any cassette configured to be inserted into or received by the device) that has a certain structure or a certain type of execution, such as a height, width and length within a specific shell and optionally with various elements, such as grooves, holes, projections, etc., intended to come into contact with mating elements, such as guides, pins, recesses, etc., in a receiving part of the analytical device 102 for properly placing the analytical cassette 104 in the analytical device 102 and positioning the analytical cassette 104 in such a way that it can properly interact with various mechanical systems in the analytical device 102 that are configured to activate various mechanisms in the analytical cassette 104.

[0058] Although not shown in Fig. 1, one or more guides or other devices within the assay device 102 may, as noted above, cause the assay cassette 104 to be positioned in a predetermined location relative to the mechanisms of the assay device 102 after the assay cassette 104 has been fully inserted or installed into the assay device 102. For example, the assay cassette 104 may be caused, such as by operation of a loading mechanism or other interface, to move vertically upward and engage one or more cassette interface mechanisms; in some other embodiments, some of the cassette interface mechanisms may be supported by movable interfaces that may be moved by an actuator after the assay cassette 104 has been fully inserted into the assay device 102 to bring the cassette interface mechanism into engagement with aspects of the cassette housing.

[0059] Fig. 2A is an off-angle view of an embodiment of the assay cassette, and Fig. 2B is a partially exploded view of the assay cassette. In Fig. 2A, the assay cassette 204 includes an assay cassette housing 206 of a design that allows it to be inserted into and accepted by an assay instrument. The assay cassette 204 also includes a perforating disk for piercing a foil membrane (not shown) within the assay cassette housing 206, having three contact points 208A-208C of the foil piercing mechanism accessible to the foil piercing mechanism of the assay instrument through openings 216A-216C of the assay cassette housing 206; two rotary valves with visible splined shafts 210A and 210B; an actuator interface 212 of a pump for moving a return member of a pump mechanism 221 within a housing 206 of an assay cassette; and a port 214 in the housing 206 of the assay cassette for receiving a heating probe (not shown) of an assay device. Although not shown obviously in Fig. 2A, the assay cassette 204 may comprise multiple reagent reservoirs, valves, membranes, a pump, flow channels and other elements for moving and holding material within the assay cassette.

[0060] An implementation of the internal structure of the assay cassette 204 is shown in Fig. 2B. As discussed in more detail below, the assay device 102 may include cassette interface mechanisms for activating each of these elements of the assay cassette (or subsets thereof for assay devices that interact with assay cassettes that do not have all such systems and/or different systems), including a foil piercing mechanism, one or more rotary valve actuators, a pump actuator, and a pinch valve actuator. Fig. 2B shows the assay cassette housing 206 with the upper portion 206A removed from the lower portion 206B. The upper part 206A includes openings 216A-216C, which provide access to the contact points 208A, 208B and 208C of the foil piercing mechanism by means of the foil piercing mechanism, openings 216D and 216E, which provide access to the spline shafts 210A and 210B, and an opening 216F, which provides access to the actuator interface 212 of the pump, which can be independent or in cooperation with a gap or opening in the lower part 206B for access to the lower part of the actuator interface 212 of the pump. An opening 214 for receiving a heater probe is also visible.

[0061] In this embodiment, the lower portion 206B of the assay cassette housing 206 includes a plurality of reservoirs, each of which may contain a reagent or other liquid that may be used by the assay device 102 during the assay. In this embodiment, there are approximately twenty-five such reagent reservoirs, which for purposes of discussion herein may be referred to as the first reagent reservoirs 218 or the second reagent reservoirs 220. It should be understood that in different embodiments of the assay cassette, a different number of reagent reservoirs and their different arrangements may be provided.

[0062] The assay cassette 204 may include a microfluidic plate (not shown) that includes a plurality of flow channels, each of which may be in fluid communication with one or more reagent reservoirs. In some embodiments, the microfluidic plate may be selectively coupled to the assay cassette 204 and may be part of a separate cassette assembly. To allow reagents to selectively flow through the channels of the microfluidic plate, one or more valves, such as rotary valves 222A and 222B, may be included in the assay cassette 204. Such rotary valves 222A and 222B may be configured to have a rotary portion that can be driven to rotate, such as by torque from the assay device, to cause different reagent reservoirs to be in fluid communication with one or more reagent flow paths within the microfluidic plate at different times. These rotary valves 222A and 222B may include splined shafts 210A and 210B (or other suitable rotary interface), respectively, as shown in Fig. 2A, for engaging with rotary drive shafts 234A and 234B of the analytical instrument 102 (described below with reference to Fig. 3).

[0063] In this embodiment, each of the reagent reservoirs in the assay cassette 204 is formed with one or more side walls 213 that rise from a bottom wall (such as a microfluidic plate) and, in the case of the first reagent reservoirs 218, are covered by a foil membrane 226 that may be attached or glued to an upper edge of the side walls 213 of the first reagent reservoirs 218. In the case of the second reagent reservoirs 220, a reservoir lid 227 that has additional foil membranes 226 attached thereto may be attached or glued to an upper edge of the side walls 224 of these second reagent reservoirs 220. The foil membranes 226 may be provided to seal the reagent reservoirs and prevent leakage of the reagents contained therein.

[0064] The analytical device 102 can activate the perforating disk 228 when the assay cassette 204 is installed in the analytical device. The perforating disk 228 can have three contact points 208A-208C of the foil piercing mechanism, which are accessible to the foil piercing mechanism of the analytical device 102 through the openings 216A-216C, respectively. The perforating disk 228 can also include a plurality of projections, each of which is located above the membrane 226 of the foil, which seals a particular reservoir such that when the piercing disk 228 is moved towards the reagent reservoirs by the foil piercing mechanism of the analytical device 102, the projections pierce the membranes 226 of the foil, thereby equalizing the pressure inside the reservoirs with the ambient pressure and thereby extracting reagents from the reagent reservoirs without creating a vacuum inside the reservoirs. If the membranes are not punctured or not sufficiently punctured to allow air to escape from the reagent reservoirs, the efficiency of the analytical instrument 102 in extracting reagents from the reagent reservoirs may be reduced due to the effects of pressure.

[0065] The foil piercing mechanism of the assay device 102 may have three engaging pins, each of which is positioned to contact one of the three contact points 208A-208C of the foil piercing mechanism of the assay cassette 204 and move the perforating disk 228 toward the reagent reservoirs. Fig. 2C is an off-angle view of the assay cassette shown in Fig. 2A with the top portion 206A removed. In this figure, with the top portion 206A removed, it is seen that the perforating disk 228 is located in the bottom portion 206B of the assay cassette. Three engaging pins 238A, 238B and 238C of the foil piercing mechanism of the analytical instrument correspond to one of the three contact points 208A-208C of the foil piercing mechanism of the analytical cassette 204, and the foil piercing mechanism can apply a linear force to each of the contact points 208A-208C of the foil piercing mechanism to move the perforating disk 228 along the axis 236C. To pierce the foil membrane 226, the engaging pins 238A 238B and 238C move downwardly (in this Figure) in the second direction 261 along the axis 236C to move the perforating disk 228 toward the foil membranes 226 (not shown in this Figure) and to ensure that the foil membranes 226 are pierced by the projections of the perforating disk 228.

[0066] The foil piercing mechanism of the assay device 102 may need to provide the same force and movement to all contact points 208A-208C of the foil piercing mechanism of the perforating disk 228 in order to ensure that all aspects of the foil membrane 226 are pierced by a predetermined amount. This may include the engaging pins 238A, 238B and 238C of the foil piercing mechanism moving progressively toward the assay cassette 204 at substantially the same time, as well as at the same speed and by the same amount, to substantially simultaneously contact the perforating disk 228, detach the perforating disk 228 from the retaining assembly and apply a uniform force to the perforating disk 228 to substantially simultaneously pierce the foil membrane 226 at a plurality of points. The retaining unit may provide resistance to the perforating disk 228 in order to reduce the likelihood of or otherwise prevent accidental displacement of the perforating disk 228, such as during transport and/or handling of the assay cassette prior to use. In addition, the foil membrane 226 may also provide resistance to the perforating disk 228 during the piercing phase, and uniform pressure may need to be applied to overcome this resistance. Uneven force generated by one of the engaging pins 238A, 238B and 238C of the foil piercing mechanism may result in displacement of the perforating disk 228 when it is removed from the retaining unit and/or in a portion of the foil not being pierced or being insufficiently pierced, which may prevent access to one or more reagent reservoirs. The points of the three engagement pins 238A, 238B and 238C that contact the perforating disk 228 may form a plane 240 that moves along the axis 236C, and the functionality of the foil piercing mechanism of the analytical device 102 may be represented by this plane 240, oriented perpendicular to the axis 236C. If the plane 240 is not perpendicular to the axis 236, then the engagement pins 238A, 238B and 238C may apply uneven force and movement toward the perforating disk 228, which may result in the perforating disk 228 being displaced when it is removed from the holding unit and/or may result in the foil membrane above some reservoirs not being pierced. To measure and determine the functionality of the foil piercing mechanism of an analytical instrument, it may be necessary to test the movement, alignment, and/or force applied by each of the foil piercing mechanism engagement pins.

[0067] As also mentioned earlier, the assay device 102 may include a rotary valve actuator for rotating the rotary valves of the assay cassette. Fig. 3 shows a cross-sectional view of the assay cassette and the rotary valve actuator of the assay device. In this case, each of the two rotary valves 222A and 222B of the assay cassette 204 has a shaft 230A and 230B connected to or including a corresponding spline shaft 210A and 210B, and a corresponding valve seat 232A and 232B. The rotary actuator of the valve of the analytical device 102 includes two rotary drive shafts 234A and 234B that can engage with the corresponding spline shafts 210A and 210B of the rotary valves 222A and 222B of the analytical cassette 204 and can rotate the said spline shafts 210A and 210B about the rotation axes 236A and 236B. The rotary actuator of the valve can include motors and gears for applying torque to each of the rotary valves 222A and 222B of the analytical cassette 204; such torques can be independently applied by the rotary drive mechanism. In order to measure and determine the functionality of the rotary valve actuator of the analytical device, it is possible to check the rotary movement and/or torque applied by each of the rotary drive shafts 234A and 234B.

[0068] The assay device 102 may also include a pump actuator 251 for moving the pump mechanism 221 within the assay cassette to create a positive or negative pressure within one or more flow channels of the assay cassette. Fig. 4 is a cross-sectional view of an embodiment of the assay cassette having a pump mechanism 221. In this case, a portion of the pump mechanism 221 of the assay cassette 204 includes an inverted U-shaped piston 242 with a plunger 244 at one end 246A and a sealed contact 248 at the second end 246B. A pump actuator interface 212 shown in Fig. 2A, which is partially shown in Fig. 4, is located at the top of the piston 242. The pump actuator 251 shown in Fig. 4, includes a pin 250 connected to a lever 252, which is configured to move by a lever movement mechanism 254, which causes the lever 252 and the pin 250 to move along an axis 256 of translational movement. The pin 250 of the analytical device contacts the sealed contact 248 of the piston 242 of the analytical cassette 204 and moves the piston 242 along a first direction 258, which is shown in Fig. 4 as directed upward; this movement of the piston 242 can create a vacuum or positive pressure in the analytical cassette 204 for moving liquids along the flow channels of the analytical cassette 204.

[0069] The pump actuator 251 shown in Fig. 4 also includes a resistive force element 260, shown as a spring, for applying a force to the pump actuator interface 212 of the piston 242 along the translational axis 256 in a direction opposite to the first direction and indicated as the second direction 262, which is shown in Fig. 4. as directed downward. The counter-directional force applied by the resistive element 260 allows the piston 242 to oscillate or reciprocate along the translational axis 256 to pump and move the contents within the assay cassette 204 when the lever movement mechanism 254 moves downward and/or disengages. It may be advantageous to measure and determine the functionality of the actuator 251 of the analytical instrument pump by checking the movement and/or force applied by the pin 250, the lever 252, the lever movement mechanism 254, and the resistive force element 260.

[0070] Some assay cassettes may also have various pinch valves in which a valve membrane is positioned over an opening. To actuate such a pinch valve, the assay device 102 may have a valve actuator system that applies a linear force to the membrane, which causes the membrane to be tightly attached to one or more openings, which may include an inlet opening and an outlet opening. Fig. 5 is a cross-sectional view of a portion of an embodiment of the assay cassette 204 and the valve actuator system of the assay device. The assay cassette 204 includes three pinch valves 264A, 264B and 264C, each of which has a pusher 266A, 266B and 266C, respectively, configured to move within the assay cassette 204 to contact a membrane 271, which, in turn, contacts and is selectively tightly pressed against liquid lines 272A, 272B and 272C, respectively. The actuator system of the valve of the analytical device 102 includes three elements 268A, 268B and 268C of the linear actuator, each of which is configured to move to contact the plungers 266A, 266B and 266C, respectively, which causes each plunger 266A, 266B and 266C to be pulled along the axis 270A, 270B and 270C, respectively, to contact the membrane 271, after which the membrane 271 seals the liquid lines 272A, 272B or 272C. Each pinch valve 264A, 264B and 264C can be configured to apply a specific force to sufficiently press the valve membrane against the opening. If this specific force is not applied, the valve can perform a poor seal. In order to test the functionality of the valve actuator system, including the applied force, it may be advisable to measure and determine the applied force of each of the elements 268A, 268B and 268C of the linear actuator of the valve actuator system.

[0071] Some assay devices may have a heating probe that is inserted into the assay cassette and brought into contact with a receptacle of the assay cassette, such as a test tube holder or reservoir, to heat the material within the receptacle. Fig. 6 is a cross-sectional view of another portion of an embodiment of the assay cassette and the heater probe. The assay cassette 204 includes a receiving portion 274 inside the housing 206 of the assay cassette and an opening 276 into which a heating probe 278 of the assay device 102 is inserted so that the heating probe 278 can contact the receiving portion 274 or a part thermally connected to the receiving portion 274, such as a heating cuff that completely or partially surrounds the receiving portion 274 and distributes heat over the receiving portion 274, and supply heat to the receiving portion 274. It may be advisable to test the functionality of the heating probe, for example the temperature created by the heating probe inside the receiving portion of the assay cassette.

Test cassette implementation options

[0072] Some test cassettes containing one or more sensors can be used to measure and determine the functionality of the assay device 102 with respect to the actuator systems of the assay cassettes. As noted with reference to Figure 1, in some assay devices 102, the assay cassette 104 can be inserted into the interface 103 of the assay device 102. As a result, the assay cassette 104 can be isolated and/or otherwise inaccessible from the outside of the assay device 102 to significantly reduce the possibility of contamination, vibration, exposure to light, etc., affecting the assay cassette 104 during operations performed by the assay device 102. In some embodiments, the various actuator systems of the assay device 102 can be tested separately prior to assembly. However, once fully assembled in the assay device 102, such actuator systems may be less accessible or completely inaccessible from the outside of the assay device 102, so determining the functionality of each actuator system may be difficult. Furthermore, since multiple actuator systems may interact during operation of the assay device 102, determining acceptable performance of multiple actuator systems at substantially the same time and/or on a simulated assay cassette 104, such as a test cassette described herein, may be used for quality control and/or field diagnostics. For example, such test cassettes may determine whether one or more actuator systems may be operating below an acceptable performance criterion and/or interfering with or affecting the performance of other actuator systems. Such determination may occur without requiring disassembly of the assay device 102 to gain access to the actuator systems therein. Moreover, in some embodiments, the test cassette may output data indicative of the performance of one or more actuator systems. In some cases, the output data may be used by the assay device 102 to update set points and/or otherwise adjust the performance of one or more actuator systems to re-adjust or otherwise change the performance of the assay device 102 to meet acceptable performance criteria.

[0073] As described in more detail below, the test cassette may include one or more linear displacement sensors for measuring linear motion and/or force applied by linear actuators of the analytical instrument, such as may be used in a punching mechanism, a pump actuator, and/or a valve actuator. The test cassette may also include one or more angular displacement sensors for measuring angular motion and/or torque caused by rotational actuator systems of the analytical instrument. In some cases, the test cassette may include one or more load cells for measuring linear force applied by the analytical instrument, and/or one or more temperature sensors for measuring performance of a heating element of the analytical instrument.

[0074] These sensors may be located within the test cassettes and may be configured to simulate various functionalities of the elements and mechanisms of the assay cassettes. This may allow the assay device to interact with the test cassette in substantially the same manner as with the assay cassette. For example, the test cassette may have angular displacement sensors with external splined shafts that have at least some of the same external features as the splined shafts of the assay cassette and that are located within the test cassette such that when the test cassette is inserted and positioned in the assay device, these splined shafts are in the same positions relative to the assay device as similar splined shafts of the assay cassette in the actual assay cassette. These angular displacement sensors may also simulate the operation of rotary valves in the assay cassette, including the resistance exerted by such valves on the actuator of the rotary valve of the assay device. Similarly, the linear displacement sensors for testing the foil piercing mechanism may have elements similar to those present in the assay cassette, for example, providing contact points for the engagement pins in the same locations as on the perforating disk, and may simulate the operation of the assay cassette, including the resistance provided by the foil membrane when pierced by the perforating disk. In some embodiments, additional sensors may also simulate the position and functionality of the elements of the assay cassette so that the assay device can interact with multiple aspects of the assay cassette. In some embodiments, the assay cassette does not provide any other functionality except for measuring the functionality of the actuators of the assay device, for example, it does not perform actual foil perforation, actual pump operation, actual valve operation.

[0075] Fig. 7 shows an embodiment of a test cassette with a plurality of sensors. This test cassette 780 has a test cassette housing 782, a plurality of first linear displacement sensors 784A, 784B and 784C, a second linear displacement sensor 786, one or more angular displacement sensors 788A and 788B and a temperature sensor (not shown) near the opening 790 of the test cassette housing 782. In turn, these and other sensors are described below.

[0076] The test cassette housing 782 may be of a type that allows the test cassette 780 to be inserted into and received by the assay device 102 in the same manner as the assay cassette 104. This allows the actuators of the assay device 102 to engage the test cassette 780 in the same manner as the assay cassette 104, which allows the test cassette 780 to measure, determine and test the actuators of the assay device 102. The test cassette 780 may be inserted into a slot, cassette receiver or other interface 103 configured to receive the assay cassette 104, thereby ensuring that the test cassette 780 is positioned, oriented and secured in a position similar to the position of the assay cassette 104 during the assay device 102 performing assay operations. For example, the test cassette 780 can be caused, for example, by operation of a loading mechanism or other interface, to move vertically upward and come into contact with one or more cassette interface mechanisms of the analytical instrument 102; in some other embodiments, some of the cassette interface mechanisms can be supported by movable interfaces that can be moved by an actuator of the analytical instrument 102 after the test cassette 780 is completely inserted into the analytical instrument 102 to bring the cassette interface mechanism into contact with aspects of the test cassette 780. In some embodiments, the design type of the test cassette housing 782 can be a prismatic volume with a total length of about 250 millimeters, including about 242 millimeters, and a total width of about 150 millimeters, including about 142 millimeters, and a total height of about 75 millimeters, including about 73 millimeters.

[0077] A plurality of first linear displacement sensors 784A, 784B and 784C can be used to measure and determine various aspects of the operation of the foil piercing mechanism of the analytical device 102, including the distance of travel and the force applied by each of the engaging pins (not shown in Fig. 7) of the analytical device 102 and the alignment of these engaging pins. When the test cassette 780 is inserted into the analytical device 102 and positioned within it in the same position as the analytical cassette 104, each of the engaging pins of the foil piercing mechanism of the analytical device 102 can contact and move one corresponding first linear displacement sensor 784A, 784B and 784C. Each of the first linear displacement sensors 784A, 784B and 784C can determine the travel distance and force applied by one of the engaging pins, as well as the alignment of all of the engaging pins relative to each other, as described below.

[0078] Fig. 8 is a cross-sectional view of the first linear displacement sensor in the test cassette 780 shown in Fig. 7. Although only one of the first linear displacement sensors, such as sensor 784A, is visible inside the housing 782 of the test cassette in Fig. 8, all of the first linear displacement sensors 784A, 784B and 784C can be substantially identical to each other and are located in locations corresponding to the contact points for the engaging pins of the puncture mechanism of the analytical device 102. Thus, although only one linear displacement sensor (784A) is described with reference to Fig. 8, this description is equally applicable to the other first linear displacement sensors 784B and 784C. The first linear displacement sensor 784A includes a movable member 792 that can move linearly along a first axis 794. The movable member 792 includes a contact point 793 with which a corresponding engaging pin, such as the engaging pin 238A shown in Fig. 8, can come into contact to move the movable member 792 along the first axis 794, for example, in a second direction 761 (this may be the same second direction as shown in Fig. 2C). Accordingly, each of the three engaging pins 238A, 238B and 238C shown in Fig. 2C, can contact the first linear displacement sensors 784A, 784B and 784C of the test cassette 780 and move them in the second direction 761. In some embodiments, the first axis 794 is located inside the housing 782 of the test cassette so that the first axis 794 is in a parallel position to the axis 236C (not shown) when the test cassette 780 is inserted and located inside the analytical device 102, so that the first linear displacement sensor 784A simulates the movement of the perforating disk 228 (not shown) of the analytical cassette 104.

[0079] The first linear displacement sensor 784A also includes a first detector 796 for determining the distance traveled by the movable member 792 along the first axis 794 relative to the body of the test cassette 782. In some embodiments shown in Fig. 8, the first detector 796 may be an optical sensor, such as an optical encoder reader, for determining the movement of the encoder tape 798 located on the movable member 792. The first detector 796 may also be another type of detector, such as an incremental sensor, a laser distance sensor, a linear displacement measuring transducer, and a magnetic encoder.

[0080] In some embodiments, it may be appropriate for the first linear displacement sensors 784A, 784B and 784C of the test cassette 780 to simulate the resistive force of the retaining assembly and/or the foil membrane that the foil piercing mechanism experiences in order to determine and measure the functionality of the foil piercing mechanism under conditions that simulate the actual operation of displacing the perforating disk and/or puncturing the foil. Thus, each first linear displacement sensor 784A, 784B and 784C may include a resistive element for applying a resistive force to the movable element 792 of the sensor along the first axis 794. In Fig. 8, this resistive element 7100 is shown as a compression spring. The resistive force may be applied by the resistive element 7100 in a first direction 757 (this may be the same first direction as in Fig. 2C), which is opposite to the second direction 761; this second direction 761 represents the direction of movement of the engagement pins 238A, 238B and 238C when they cause the perforating disk 228 to pierce the foil membrane 226 on the assay cassette 204, and the first direction 757 represents the direction of resistance of the foil membrane 226 to the movement of the perforating disk 228 and the engagement pins 238A, 238B and 238C. In some embodiments, the first direction 757 may additionally or alternatively represent the resistance force of the retaining assembly that holds the perforating disk 228 in place between uses. The perforating disk 228 is held in the storage position by the retaining unit and during operation the perforating disk 228 is separated by the engaging pins 238A, 238B and 238C and moves towards the assay cassette 204 under the action of a force of a certain magnitude applied by the engaging pins 238A, 238B and 238C in the second direction 761 with respect to the perforating disk 228, which overcomes the retaining force of the retaining unit, as represented by the first direction 757, thereby releasing the perforating disk 228 and allowing it to move.

[0081] Such a design of the first linear displacement sensors 784A, 784B and 784C allows for measuring and determining whether each individual engagement pin 238A, 238B and 238C has moved a required amount, as well as whether the individual engagement pins 238A, 238B and 238C are aligned with each other, including during simulated operation, such as puncturing a membrane and/or detaching from a retaining assembly. If one or more of the distances measured by each first linear displacement sensor 784A, 784B and 784C are not within a first threshold of the first distance and/or are not within a second threshold of each other, this may indicate that the engaging pins 238A, 238B and 238C are not aligned with each other, are not at the same level and/or do not function properly. Returning to Fig. 2C, this may also indicate that the plane 240 is not perpendicular to the axis 236C or is not within a threshold of the perpendicularity value.

[0082] For example, if the first measured distance by one first linear displacement sensor 784A is not within a first threshold from the first distance, this may indicate that the engaging pin that has come into contact with this first linear displacement sensor 784A is not aligned or does not function properly. Similarly, if the first measured distance by this first linear displacement sensor 784 is outside a second threshold from the measured distances of two other first linear displacement sensors 784B and 784B, this may indicate that the engaging pins are not aligned with each other. In some embodiments, the movement of each first linear displacement sensor 784A, 784B and 784C can be from about 0.01 millimeters to 10 millimeters, including from about 0.1 millimeters to 9 millimeters, and from about 0.01 millimeters to 8.4 millimeters, and it can be appropriate that the first threshold is, for example, within ±10%, ±5% or ±1% of this amount of movement. In some embodiments, the engaging pins 238A, 238B and 238C can be considered aligned if the distances they travel are, for example, within ±10% of each other, ±5% of each other, ±1% of each other; these values can form the second threshold.

[0083] Since the foil membrane provides resistance to the perforating disk, which in turn provides resistance to the engagement pins of the foil piercing mechanism of the analytical instrument, measuring the performance of the foil piercing mechanism under resistance may be useful since the performance of the foil piercing mechanism may differ with and without applied resistance. Measurements made using the first linear displacement sensors, each having a resistive element, may allow the performance of the foil piercing mechanism of the analytical instrument to be assessed under the conditions of a simulated piercing procedure of the foil membrane of the analytical cassette. These measurements may include determining whether each individual engagement pin has moved a required amount and whether the individual engagement pins are aligned with respect to each other during the piercing operation. Thus, this may allow the application of pressure by the foil piercing mechanism to the foil membrane to be determined correctly and uniformly.

[0084] The use of the first linear displacement sensors 784A, 784B and 784C, each of which has a resistive element (7100), can also make it possible to determine the force applied to each sensor. According to Hooke's law, the force of compression or extension of a spring is directly proportional to the distance it moves, which is represented as , where F is the force, k is the spring constant, x is the spring displacement. Therefore, the force applied by each engaging pin 238A, 238B and 238C to each first linear displacement sensor can be determined by measuring the displacement distance traveled by the movable elements in each of the first linear displacement sensors 784A, 784B and 784C and multiplying these distances by the known constant of the resistive element 7100 for each first sensor FF84A, 784B and 784C. This can make it possible to determine the force applied by the engaging pins 238A, 238B and 238C, as well as to determine whether they apply a predetermined force, for example, the same force or a force that meets or exceeds a threshold force. In some embodiments, the force applied to each first linear displacement sensor 784A, 784B and 784C may be at least about 25 newtons (N), including at least about 30 N, about 33 N and about 35 N, and it may be appropriate for the threshold value to be, for example, within ±10%, ±5% and ±1% of this value.

[0085] In some embodiments, the test cassette housing 782 may have a plurality of first openings that allow the engagement pins 238A, 238B and 238C to contact the first linear displacement sensors 784A, 784B and 784C and move into the test cassette housing 782, and a plurality of second openings that allow the movable members of the first linear displacement sensors 784A, 784B and 784C to move outside the test cassette housing 782, while the movable members of each first linear displacement sensor 784A, 784B and 784C are moved by the engagement pins 238A, 238B and 238C. In Fig. 8, one first opening 7102 and one second opening 7104 of the test cassette housing 782 are shown. The first opening 7102 allows the shown engagement pin 238A to contact the movable element 792 and move into the housing 782 of the test cassette. The second opening 7104 allows the movable element 792 to move in the second direction 762 through the second opening 7104 outside the housing 782 of the test cassette. The housing 782 of the test cassette includes the first and second openings 7102 and 7104 for each of the first linear displacement sensors 784A, 784B and 784C. In some embodiments, the second openings 7104 may be absent, and the movable element 792 moves inside the housing 782 of the cassette, but not outside the housing 782 of the cassette.

[0086] Returning to Fig. 7, the test cassette 780 may also or alternatively include a second linear displacement sensor 786 that may be used to measure and determine the functionality of the pump actuator 251 of the analytical instrument. For example, the second linear displacement sensor 786 may measure the distance that the lever 252 and the pin 250 move along the translation axis 256 by the lever movement mechanism 254, as shown in Fig. 4. This second linear displacement sensor 786 may have the same or similar functionality as the first linear displacement sensors 784A, 784B and 784C described above.

[0087] Fig. 9 is a cross-sectional view of a second linear displacement sensor in the test cassette 780 shown in Fig. 7. The second linear displacement sensor 786 includes a second movable member 7106 that can move linearly along a second axis 7108. The second movable member 7106 includes a contact interface 7110 that can be contacted by a resistive force element 260 of the pump actuator 251 shown in Fig. 4, similar to the interface 212 of the actuator of the pump of the assay cassette 204. In some embodiments, the second axis 7108 is located within the housing 782 of the test cassette such that the second axis 7108 is in a parallel position to the axis 256 (not shown in Fig. 9, but shown in Fig. 4) when the test cassette 780 is inserted and positioned within the assay device 102, so that the second linear displacement sensor 786 simulates the movement of the piston 242 (not shown) of the assay cassette 104. The second linear displacement sensor 786 also includes a second detector 7112 for determining the distance traveled by the second movable element 7106 along the second axis 7108 relative to the housing 782 of the test cassette. In some embodiments, shown in Fig. 9, the second detector 7112 may be an optical sensor, such as an optical encoder reader, for detecting the movement of the encoder tape 7114 located on the second movable element 7106. The detector 7112 may also be another type of detector, such as an incremental sensor, a laser distance sensor, a linear displacement measuring transducer, and a magnetic encoder.

[0088] The second linear displacement sensor 786 of the test cassette 780 may be used to measure and determine the functionality of the pump actuator of the analytical instrument. Returning to Fig. 4, discussed above, the lever movement mechanism 254 of the analytical instrument 102 causes the lever 252 and the pin 250 to move along the axis of movement 256 in the first direction 259. When the test cassette 780 is positioned inside the analytical instrument 102, the pin 250 of the analytical instrument may contact the first end 7116 of the second movable member 7106 (as shown in Fig. 9), and the lever movement mechanism 254 of the analytical instrument 102 may cause the second movable member 7106 to move along the second axis 7108 with the help of the lever 252 and the pin 250 (as shown in Fig. 9) in the first direction 758 (Fig. 9), which may be the same as the axis 256 of movement and the first direction 259 shown in Fig. 4. During this movement, the resistive force element 260 of the analytical instrument 102, shown in Fig. 4, can apply a force to the contact interface 7110 of the second movable element 7106 along the second axis 7108 in the second direction 262, which can also be the same as the axis 256 of movement and the first direction 259 shown in Fig. 4.

[0089] When the lever movement mechanism 254 of the analytical instrument 102 moves the second movable element 7106, the detector 7112 measures the distance traveled by the second movable element 7106 to determine the total distance traveled by the lever movement mechanism 254, as well as the force applied by the lever movement mechanism 254. The force can be determined using a known stiffness coefficient of the resistance force element 260 of the analytical instrument and the measured displacement distance. It can also be determined whether the measured distance and the applied force are specified values and/or are within acceptable threshold values from these values, such as ±10%, ±5%, ±4%, or ±1%. In some such embodiments, the movement of the second linear displacement sensor 786 may be from about 0.01 millimeters to 35 mm, including from about 0.1 mm to 30 mm, from about 0.01 mm to 28 mm and from about 0.01 mm to 27.6 mm, and it may be appropriate that this distance is, for example, within ±10%, ±5% and ±1% of this value.

[0090] In some embodiments similar to those described above, the test cassette housing 782 may have another first opening 7113 and another second opening 7115 to allow movement of the second movable member 7106. For example, the other first opening 7113 and the other second opening 7115 may be opposite each other, the pin 250 of the assay instrument may be configured to be inserted through the other second opening 7115 to move the second movable member 7106 along the second axis 7108 in the first direction 758. When the second movable member 7106 is moved in the first direction 758 along the second axis 7108, the first end 7116 of the second movable member 7106 may pass through the other second opening 7115, and the second movable member 7106, including the contact interface 7110, may also move through the other first opening 7113. Similarly, when the second movable member is moved 7106 in the second direction 762 the second movable element 7106 can pass through another first opening 7113, and the first end 7116 can pass through another second opening 7115.

[0091] Although not shown in Fig. 7, the test cassette 780 may also or alternatively include a plurality of load cells for measuring one or more linear forces applied by the analytical device, such as the valve actuator of the analytical device. Fig. 9 shows one load cell 7111, which is accessible through the bottom of the test cassette housing 782. These load cells 7111 can be used to measure the force applied by three elements 268A, 268B and 268C of the linear actuator of the valve actuator along axes 270A, 270B and 270C, respectively. In some embodiments, these load cells may use a strain gauge. When in contact with the linear actuator element 268A, 268B or 268C, each load cell 7111 can deflect and change or generate a value that can be used to determine the magnitude of the applied force. For example, the load cell 7111, including a strain gauge, can change its resistance under the action of a force applied by the linear actuator element 268A, 268B or 268C, and this change in resistance can cause a change in the voltage on the load cell 7111, which, in turn, can be used to determine the applied force. The load cells can be capable of measuring various forces, including from about 0 N to about 30 N, including from about 0 N to 20 N. In some other embodiments, the load cell 7111 is capable of determining and measuring the applied force of any other element of the analytical device, such as one of the engaging pins 238A, 238B and 238B.

[0092] The test cassette 780 shown in Fig. 7 may also or alternatively include one or more angular displacement sensors 788A and 788B that may be used to measure and determine the functionality of the rotary input mechanism of the assay device 102, such as the rotary valve drive mechanism described above and shown in Fig. 3. This may include testing and measuring the rotary displacement and/or torque imparted by each of the rotary drive shafts 234A and 234B shown in Fig. 3. Similar to the first linear displacement sensors described above, it may be advantageous for the angular displacement sensors 788A and 788B of the test cassette 780 to simulate the resistance and displacement of the rotary valves 222A and 222B of the assay cassette 104.

[0093] Fig. 10 is a cross-sectional view of an angular displacement sensor in the test cassette 780 shown in Fig. 7. This sensor, which may be the angular displacement sensor 788A, may include a pivot member 7118 configured to rotate about an axis of rotation 7120, as indicated by the double arrow 2122. The axis of rotation 7120 is located within the housing 782 of the test cassette such that when the test cassette 780 is inserted into the assay device and positioned therein, the axis of rotation 7120 is in a parallel, and in some embodiments, collinear, position to the axes of rotation 236A and 236B described above and shown in Fig. 3. This may allow the rotary drive shafts 234A and 234B of the analytical instrument to engage the rotary member 7118 of the angular displacement sensor 788A of the test cassette 780 and rotate it about the rotation axis 7120, similar to the rotation of the rotary valves 222A and 222B of the analytical cassette, including rotation about the axes 236A and 236B shown in Fig. 3. The angular displacement sensor 788A may also include a detector 7124 for detecting and measuring the angle moved by the rotary member 7118. In some embodiments, the detector 7124 may be an optical sensor, such as an optical encoder reader, for detecting the angle moved by the encoder disk 7126 located on the rotary member 7118. The detector 7124 may also be another type of detector, such as an incremental sensor and a magnetic encoder.

[0094] In some embodiments, it may be appropriate for the angular displacement sensor 788A to have a resistance, including an adjustable resistance, with respect to the angular displacement of the rotary member 7118 to simulate the resistance of the rotary valves on the assay cassette. This resistance can be applied in various ways. In Fig. 10, the angular displacement sensor 788A includes a friction element 7128 that contacts a first surface 7130 of the rotary member 7118 to apply frictional resistance with respect to the rotary member 7118. During rotation of the rotary member 7118 about the axis of rotation 7120, friction between the first surface 7130 and the friction element 7128 causes the rotary member 7118 to experience rotational resistance. In some cases, the angular displacement sensor 788A may also include a resistive element 7132, shown in Fig. 10 in the form of a spring that can apply an axial force to the rotary member 7118 to increase friction and, therefore, rotational resistance with respect to the rotary member. In some such cases, as shown in Fig. 10, the angular displacement sensors 788A and 788B can include both the resistive element 7132 and the friction element 7128, which can work together to cause rotational resistance with respect to the rotary member 7118 using the resistive element 7132, applying an axial force along the axis of rotation 7120 in the first direction 758 to the friction element 7128 and causing additional frictional resistance between the friction element 7128 and the rotary member 7118 on the first surface 7130. In some examples, the axial force applied by the resistive element 7132 can be adjustable. For example, in Fig. 10 the force applied by the resistive element 7132, i.e. the spring, can be adjusted by compressing or releasing the spring inside the housing 7136 of the angular displacement sensor 788A.

[0095] In some embodiments, the rotary member 7118 may also include elements for engaging with the rotary valve drive mechanism, including the rotary drive shafts 234A and 234B shown in Fig. 3. These elements may include a splined shaft 7134 on the rotary member 7118, as well as gears and a slotted keyway.

[0096] As the rotary valve drive mechanism of the analytical instrument 102 rotates each sensor 788A and 788B of the angular movement of the test cassette 780, the detector 7124 measures the angle by which the rotary member 7118 rotates to determine the total angle by which each of the rotary drive shafts 234A and 234B of the rotary valve drive mechanism rotates. In some embodiments, each rotary member 7118 can be configured to rotate by a certain amount, including at least 250 degrees, 275 degrees, 300 degrees, 320 degrees, 340 degrees and 345 degrees. It can be determined whether the measured angle is within a threshold angle value, such as within ±10%, ±5%, ±1%, ±0.5% and ±0.3% of this value. In some embodiments, the torque applied to each rotary member may also be determined by the angular displacement sensors 788A and 788B. For example, in the embodiment shown in Fig. 10, the torque may be calculated using a known resistance, an applied axial force, and a measured angle of movement. In some other embodiments, the angular displacement sensors 788A and 788B may include a torque sensor for measuring the torque. The above description of the angular displacement sensor 788A applies equally to the angular displacement sensor 788B; these sensors may be identical to each other or provide similar functionality and use similar structures. In some embodiments, when there are two or more angular displacement sensors, such as 788A and 788B, the axes of rotation of at least two of these sensors may be parallel to each other.

[0097] The test cassette 780 may also or alternatively include a temperature sensor near the port 790 of the test cassette housing 782 for measuring the temperature in the test cassette 780 caused by a heating element of the assay device, such as a heating probe. As described above with reference to Fig. 6, the assay device 102 may have a heating element for heating the receptacle and its contents inside the assay cassette. Therefore, it may be advisable to measure the temperature inside the receptacle vessel to determine whether the contents inside the receptacle are heated to the desired temperature. In some embodiments, the temperature of an intermediate component, such as a heating collar or tape, may instead be measured. Fig. 11 is a cross-sectional view of the temperature sensor in the test cassette 780 shown in Fig. 7. The temperature sensor 7138 includes a test receptacle 7140 and a temperature detector 7142 located inside the test receptacle 7140 for detecting and measuring the temperature inside the test receptacle 7140. The body 782 of the test cassette also includes a port 790 into which a heating probe (not shown) of the analytical device 102 can be inserted to heat the test receptacle 7140. In some examples, the test receptacle 7140 can be made of the same material as the receptacle of the analytical cassette, for example, of thermoplastic, metal such as copper, copper alloy, aluminum or aluminum alloy, and stainless steel or another material such as ceramic, to simulate heat transfer of the analytical cassette and the heating conditions inside it. The test receiving portion 7140 may also include the same elements of the receiving portion of the assay cassette, such as a heating cuff, an internal volume and a wall thickness. The temperature detector 7142 is configured to detect a temperature in the receiving portion; the temperature detector 7142 may be a thermocouple, a thermistor, a passive infrared sensor and a resistance temperature detector (RTD). The temperature detector 7142 may be configured to detect temperatures in the range from about 0 degrees to about 125 degrees, including from about 0 degrees to 100 degrees...

[0098] In some other embodiments of the test cassette 780, the test cassettes 780 may have only some of the sensors described above. For example, some test cassettes 780 may include only a plurality of first linear displacement sensors, and not include the remaining sensors. In another embodiment, some test cassettes 780 may have two angular displacement sensors and temperature sensors. It is contemplated that the test cassettes 780 according to the present description may have any combination of sensors proposed in the present document.

[0099] Each of the above-described sensors may generate data, and some test cassettes 780 may include one or more memory devices for storing such generated data. Some test cassettes 780 may also include one or more processors that communicate with the sensors and one or more memory devices and that can receive data and store this data in one or more memory devices; the one or more processors may also or alternatively access data stored in one or more memory devices, transmit this data, as described below. In some embodiments, the one or more processors and one or more memory devices may be part of the controller of the test cassette 780. Returning to Fig. 7, the controller 7141 with the processor 7143 and the memory device 7144 are shown on the test cassette 780 to indicate that this test cassette 780 includes the controller 7141 with the processor 7143 and the memory device 7144.

[0100] The processor 7143, coupled to (e.g., operating in conjunction with) the memory device 7144 (which may be one or more memory devices), may execute program code instructions and may include one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Such a processor may be configured to implement any of the techniques presented in this description. The general-purpose processor may be a microprocessor; but in an alternative embodiment, the processor may be any standard processor, controller, microcontroller, or state machine. The memory device 7144 may include memory or storage media such as random access memory (RAM) such as synchronous dynamic random access memory (SDRAM), read-only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read-only memory (EEPROM), flash memory, magnetic or optical storage media, and the like.

[0101] The controller 7141 may also be communicatively connected to each of the sensors, including each of the detectors, including the first detector 796 of each of the first linear displacement sensors 784A, 784B and 784C, the second detector 7112 of the second linear displacement sensor 786, the load sensors 7111, the detector 7124 of each of the angular displacement sensors 788A and 788B and the temperature detector 7142 of the temperature sensor 7138. Each of these sensors may generate data as described above, such as measurement data (e.g., distance data, angle data, stretch data, stress data and temperature data), which may be transmitted to the controller 7141 and stored in the memory device 7144.

[0102] In some embodiments, the test cassette 780 may also include a data access port 785 (shown in Fig. 7) communicatively coupled to the controller 7141 and configured to connect to an external device and transmit data stored in the memory device 7144 to the external device, such as a computer, a smart device, another controller, a server, etc. In some embodiments, the test cassette 780 may also include a wireless communication interface communicatively coupled to the controller 7141 for wirelessly connecting to the external device and wirelessly transmitting data stored in the memory device 7144 to the external device.

[0103] In some embodiments, the test cassette 780 may also include a communication interface 787 for communicating with the assay device 102 or another device and for transmitting data generated by the sensors of the test cassette 780 to the assay device 102 (or other device). The communication interface 787 may exchange data with a corresponding communication interface of the assay device, which may be a wireless or wired connection between the assay device and the test cassette. The assay device 102 may receive and store this generated data and/or may make adjustments to its actuators based on the generated and received data. Testing may be one or more actuations or interactions of the sensors of the test cassette 780 by the assay device 102, including any possible ones described herein. For example, testing the foil piercing mechanism of the analytical instrument 102 may include contacting and moving three first linear displacement sensors of the test cassette 780 with the engaging pins of the analytical instrument 102, during which each of these sensors can generate data on displacement for the corresponding movable elements. This data on displacement can be stored in the memory device of the test cassette 780 and/or transmitted to the analytical instrument 102. After receiving the data by the analytical instrument 102, an adjustment of the foil piercing mechanism can be performed based on the generated data, for example, an adjustment of the distance of displacement by one of the engaging pins.

[0104] In some embodiments, the movement data may be data generated by each of the first linear displacement sensors 784A, 784B and 784C. This may include raw data generated by each of the sensors 784A, 784B and 784C, the total distance traveled by each movable element 792 of each first linear displacement sensor 784A, 784B and 784C, and the distance traveled in each direction (for example, in the first and second directions 761 and 757 shown in Fig. 8). This may also include determining the force applied by the linear actuator, determining whether the distance traveled by each movable member 792 of each first linear sensor 784A, 784B and 784C is within or outside a threshold value, such as a pass/fail assessment with respect to one or more predetermined threshold values, and determining whether the distances traveled by each movable member 792 of each first linear sensor 784A, 784B and 784C indicate that they are aligned (e.g., are in the same plane) with each other, as described herein. This movement data may be transmitted to an analytical instrument and used to calibrate the analytical instrument. Such calibration may include adjusting the travel distance and/or the force applied by the foil piercing mechanism.

[0105] In some embodiments, the movement data may be data generated by the second linear displacement sensor 786. This may include the total distance traveled by the second movable element 7106 of the second linear displacement sensor 786 and the distance traveled in each direction (for example, in the first and second directions 762 and 758 in Fig. 9). This may also include determining the force applied by the pump actuator and determining whether the distance traveled by the second movable element 7106 is within or outside a threshold, such as a pass/fail assessment with respect to one or more predetermined threshold values. This movement data may be transmitted to the analytical instrument and used to calibrate the analytical instrument. Such calibration may include adjusting the travel distance and/or the force applied by the pump actuator 251 (as shown in Fig. 4).

[0106] In some embodiments, the movement data may be generated by each of the angular displacement sensors 788A and 788B. This may include the total angle that each rotary member 7118 of each of the angular displacement sensors 788A and 788B rotates, the distance that movement occurs in each direction (for example, clockwise and counterclockwise around the rotation axis 7120 shown in Fig. 10), and the torque generated by the valve actuator. This may also include a determination of whether the distance traveled by each rotary member 7118 of each angular displacement sensor 788A and 788B is within or outside a threshold value, such as a compliance assessment with respect to one or more predetermined threshold values. This movement data may be transmitted to an analytical instrument and used to calibrate the analytical instrument. Such calibration may include adjustments to the travel angle and/or the force applied by the valve actuator.

[0107] In some embodiments, the travel data may be data generated by each load cell 7111. This may include the total force applied by each element of the valve actuator. This may also include a determination of whether the force measured by each load cell 7111 is within or outside a threshold, such as a pass/fail assessment with respect to one or more predetermined thresholds. This travel data may be transmitted to an analytical instrument and used to calibrate the analytical instrument. Such calibration may include adjusting the travel distance or the force applied by the valve actuator.

[0108] In some embodiments, the data received and stored by the controller 7141 may represent data generated by the temperature sensor, including data from the initial temperature detector 7142 and the measured temperature. This may also include a determination of whether the temperature is within or outside a threshold, such as a pass/fail evaluation with respect to one or more predetermined thresholds. This data may be transmitted to the analytical instrument and used to calibrate the analytical instrument. Such calibration may include adjusting the heat supplied by the heater, such as increasing or decreasing the power supplied to the heater.

[0109] It may also be determined whether the generated data indicates any improper functioning of the foil piercing mechanism, such as whether the distance traveled by the linear displacement sensor is outside a threshold, whether the force is outside a predetermined threshold, and/or whether the engagement pins are aligned with each other. Such a determination may be made by a processor or other data processing logic on the test cassette or in the analytical instrument. An adjustment to the analytical instrument may also be based on this determination. After such an adjustment, another test or interaction between the test cassette and the foil piercing mechanism may be performed. Additional adjustments, determinations, and tests may be repeated for the foil piercing mechanism.

[0110] Similarly, the testing and adjustment of the analytical instrument can be performed using any other sensors of the test cassette. This may include a valve drive mechanism that interacts with the angular displacement sensors of the test cassette and rotates the rotary elements, the angular displacement sensors that generate data during rotation, the test cassette that transmits the generated data to the analytical instrument, an evaluation of this data (for example, whether the rotary element has been rotated by a predetermined value), and the analytical instrument that adjusts the valve drive mechanism at least in part based on this data.

[0111] In some such embodiments, a testing methodology may be performed that may include a cassette inserted into and positioned within an analytical device, a mechanism of the analytical device that actuates a sensor on the test cassette that generates data during actuation of the analytical device, and the test cassette that transmits these generated data to the analytical device. The analytical device may adjust the mechanism based on these generated data. In some embodiments, the analytical device may also determine whether the sensor data indicates that the sensor element is outside a threshold value; the analytical device may then adjust the mechanism based on this determination.

[0112] In some embodiments, the test cassette and/or the assay device may include a notification mechanism that may provide a notification with information related to a test result and/or data generated by one or more sensors of the test cassette. The "notification" may be one or more of an alarm, a warning, a message, an audible output, an electronic communication, an electromagnetic communication, and/or a visual output. The notification may indicate a warning or an error indicating that one or more mechanisms of the assay device are outside predetermined thresholds. The notification may also indicate that one or more mechanisms of the assay device are within predetermined thresholds. The notification may be based at least in part on data generated by one or more sensors of the test cassette, including any or all of the motion data, determinations, and assessments described herein.

[0113] Notifications may be provided via various media and, in some cases, may require additional actions by an intermediate device before being perceived by a user. For example, a notification mechanism may include a display or lights configured to display graphical images or a backlight for the purpose of attracting a person's attention (in this case, a notification may refer to a signal sent to the lights or display that results in a backlight or display of graphical images for a person; a notification may also refer to the light or graphical images that are emitted or displayed by components receiving the signal in response to the signal). In some other or additional examples, a notification mechanism may include a wireless interface and the alert may be in the form of an electronic or electromagnetic communication, such as a wireless signal sent to another device, such as an analytical device, a computer, or a smartphone, associated with a person (in this case, the alert may be an electromagnetic signal; a notification may also refer to any audio, visual, tactile, or other outgoing signal generated by the receiving device in response to receiving the signal). The notification mechanism may be configured to generate and/or issue one or more notifications to the user and may include one or more components that may be used to generate audio, visual, electromagnetic or other types of notifications.

[0114] The test cassettes described herein provide a number of benefits and advantages. For example, they provide greater ease of performing diagnostics on an analytical instrument. By inserting such test cassettes into such analytical instruments, multiple subsystems of the analytical instruments can be tested sequentially or simultaneously to assess whether any subsystems are faulty and, if so, to determine what they are and what they are. This allows potential problems associated with the analytical cassette processing systems to be diagnosed without disassembling the analytical instrument itself.

[0115] Test cassettes may be used for initial calibration or quality control of an assay instrument. In some such embodiments, test cassettes may be inserted into an assay instrument, and actuators of the assay instrument may engage the test cassette and cause one or more sensors of the assay cassette to generate data when activated by the assay instrument, as described herein. This generated data may be stored in the assay instrument and/or the test cassette and used to evaluate whether each of the actuators of the assay unit is within predetermined thresholds. The evaluation may be performed by the assay instrument and/or the test cassette, and the evaluation may be in the form of a notification (e.g., a message or a light indicator) indicating whether each of the actuators of the assay unit is within one or more predetermined thresholds. Corrective action, such as adjustment or repair, can be applied to the analysis unit to address actuators that are outside specified thresholds.

[0116] These generated data can also be used to determine baseline measurements of the actuators of the analytical device, which can be used in comparison with subsequently generated data of the same analytical device to detect problems in the analytical device. For example, a test cassette can generate data on the actuators of the analytical device immediately after manufacture and before use in practice. After a certain period of time or a number of uses after the generation of these baseline data, for example, the test cassette can be reinserted into the analytical device, and the actuators of the analytical device can again engage with the test cassette and cause one or more sensors of the analytical cassette to generate data when activated by the analytical device. These sequentially generated data can be compared with the initially generated data or with some previously generated data to determine whether the actuators of the analytical unit are operating in the same way as initially or in accordance with the data of previous measurements, for example, whether each of the actuators of the analytical unit is operating within specified thresholds. In some embodiments, the initially generated data may be used to re-adjust the assay unit by re-adjusting the assay unit so that its actuators match the initially or previously generated data. This may allow the use of field diagnostic test cassettes to detect problems with assay instruments, as well as to re-adjust stored values based on the output data from the test cassette.

[0117] It should be understood that the above description covers the following list of embodiments. It should also be understood that this list is not a limiting or exhaustive list of the various embodiments covered by this description.

[0118] Implementation 1. A test cassette for insertion into an analytical instrument having a linear actuator, a rotary actuator, a heater, a pump actuator, a second linear actuator, and a cassette receiver, the test cassette comprising: a test cassette housing of a design suitable for receiving cassettes by the receiver of the analytical instrument; a plurality of first linear displacement sensors, wherein each of the linear displacement sensors has a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a first portion of each of the plurality of first linear displacement sensors is located in the body of the test cassette so that its corresponding first movable element engages with the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, and wherein each first detector of each of the plurality of first linear displacement sensors is designed to determine a first distance traveled by the corresponding first movable element along the corresponding first axis relative to the body of the test cassette in response to linear input data provided by the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument; a second linear displacement sensor having a second detector and a second movable element configured to move linearly along a second axis, wherein at least a second portion of the second linear displacement sensor is located inside the body of the test cassette so that the second movable element engages with the actuator of the pump of the analytical device when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated, and wherein the second detector is configured to determine a second distance traveled by the second movable element along the second axis relative to the body of the test cassette when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated; an angular displacement sensor having a third detector and a rotary element rotating about a third axis, wherein the angular displacement sensor is located inside the housing of the test cassette so that the rotary element engages with a rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the third detector is designed to determine the angle by which the rotary element rotates about the third axis relative to the housing of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated; a temperature sensor having a receiving portion in the housing of the test cassette and a temperature detector located inside the receiving portion, wherein the temperature sensor is located inside the housing of the test cassette so that the receiving portion engages with a heater of the analytical instrument when the test cassette is inserted into the analytical instrument, and wherein the temperature detector is designed to determine the temperature inside the receiving portion when the test cassette is inserted into the analytical instrument; and a plurality of load sensors, wherein each of the plurality of load sensors is located within the housing of the test cassette such that each load sensor engages with the second linear actuator upon insertion of the test cassette into the analytical instrument and activation of the second linear actuator of the analytical instrument, and wherein each of the plurality of load sensors is designed to determine a force applied to the corresponding load sensor upon insertion of the test cassette into the analytical instrument and activation of the second linear actuator of the analytical instrument.

[0119] Implementation 2. Implementation 1 of the test cassette may further include a controller having one or more processors and one or more memory devices, wherein the controller is coupled with the ability to exchange data with each first detector of each of the plurality of first linear displacement sensors, the second detector of the second linear displacement sensor, the third detector of the angular displacement sensor, the temperature detector of the temperature sensor and each of the plurality of load sensors, and the controller is configured to receive and store data generated by each first detector, the second detector, the third detector, the temperature sensor and each of the plurality of load sensors.

[0120] Embodiment 3. The test cassette of any one of embodiments 1-2, wherein the controller may be configured to perform transmission of updated movement data to the analytical instrument, and the updated movement data is at least partially based on one or more data generated by one or more of the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors.

[0121] Embodiment 4. The test cassette of any one of embodiments 1-3, wherein the controller may be configured to perform transmission of data generated by the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors to the analytical device, and the analytical device may issue a notification based at least in part on the data generated by the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors.

[0122] Implementation 5. The test cassette according to any of embodiments 1-4, further comprising a communication interface for transmitting data generated by each of the plurality of first linear displacement sensors, the second linear displacement sensor, the angular displacement sensor, the temperature sensor, and the plurality of load sensors to an external device.

[0123] Embodiment 6. A test cassette according to any one of embodiments 1-5, wherein the external device is an analytical instrument.

[0124] Embodiment 7. The test cassette according to any one of embodiments 1-6, wherein each of the plurality of first linear displacement sensors further includes a first resistive element for applying a first resistive force to the first movable element along the first axis, and the angular displacement sensor further includes a second resistive element for applying a second resistive force to the rotary element.

[0125] Embodiment 8. The test cassette according to any one of embodiments 1-7, in which the angular displacement sensor further includes a friction element for contacting and applying a frictional force to the rotary element, the angular displacement sensor further includes a resistive element arranged such that the friction element is located between the resistive element and the rotary element, and the resistive element can be designed to apply a force to the friction element along the third axis and in a direction toward the rotary element.

[0126] Embodiment 9. The test cassette according to any one of embodiments 1-8, further comprising a second angular displacement sensor having a second angular detector and a second rotary member rotating about a second axis of rotation, wherein the second angular displacement sensor is arranged such that the second rotary member engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated, and wherein the second angular detector is configured to determine a second angle through which the second rotary member rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated.

[0127] Embodiment 10. A test cassette for insertion into an analytical instrument having a linear actuator and a cassette receiver, wherein the test cassette comprises: a test cassette housing of a type suitable for receiving cassettes by the receiver of the analytical instrument; and a plurality of linear displacement sensors, each of the linear displacement sensors having a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a portion of each of the linear displacement sensors is located in the test cassette housing so that its corresponding first movable element engages with the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, and each detector is designed to determine a distance traveled by the corresponding first movable element along the corresponding first axis relative to the test cassette housing upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument.

[0128] Embodiment 11. The test cassette of embodiment 10, wherein each linear displacement sensor further includes a resistive element for applying a resistive force to the first movable element along the first axis in the first direction.

[0129] Embodiment 12. The test cassette of any one of embodiments 10-11, wherein the resistive element is a compression spring.

[0130] Embodiment 13. The test cassette of any one of embodiments 10-12, wherein each linear displacement sensor further includes a contact portion with which the engaging pin of the linear actuator contacts.

[0131] Embodiment 14. The test cassette of any one of embodiments 10-13, wherein each movable element includes a strip of an encoder, and each detector is an optical sensor for detecting movement of the strip of an encoder included in the corresponding movable element.

[0132] Implementation 15. The test cassette according to any one of embodiments 10-14, further including a controller having one or more processors and one or more memory devices, wherein the controller is coupled with the possibility of transmitting data with each first detector of each linear displacement sensor, and the controller is configured to receive and store data generated by each first detector of each of the linear displacement sensors.

[0133] Implementation 16. The test cassette of any one of embodiments 10-15, further comprising a communication interface for transmitting data generated by each of the one or more first linear displacement sensors.

[0134] Embodiment 17. The test cassette of any one of embodiments 10-16, wherein the communication interface is configured to transmit data generated by each of the one or more first linear displacement sensors to the analytical instrument, the controller is configured to transmit calibration data to the analytical instrument, and the calibration data is at least partially based on data generated by the one or more first linear displacement sensors of the analytical instrument.

[0135] Implementation 18. A test cassette for insertion into an analytical instrument having a pump actuator and a cassette receiver, wherein the test cassette comprises a test cassette housing of a type suitable for receiving cassettes by the receiver of the analytical instrument, a first opening and a second opening opposite the first opening, wherein the second opening is intended to receive a portion of the pump actuator of the analytical instrument; and a linear displacement sensor having a detector and a movable element configured to move linearly along a first axis, wherein at least a portion of the movable element is located inside the body of the test cassette in the test cassette, the movable element is located between the first opening and the second opening, the movable element is configured to engage and move a portion of the pump actuator inserted through the second opening, when the test cassette is inserted into the analytical device and the pump actuator of the analytical device is activated, and when the pump actuator is moved when the test cassette is inserted into the analytical device and the pump actuator of the analytical device is activated, the movable element is configured to move through the first opening, and the detector is configured to determine the distance traveled by the movable element along the first axis relative to the body of the test cassette.

[0136] Embodiment 19. The test cassette of embodiment 18, further including a controller having one or more processors and one or more memory devices, wherein the controller is coupled with the ability to transmit data to the linear displacement sensor detector, and the controller is configured to receive and store data generated by the linear displacement sensor detector.

[0137] Implementation 20. The test cassette according to any of embodiments 18-19, further comprising a communication interface for transmitting data generated by the linear displacement sensor.

[0138] Embodiment 21. A test cassette for insertion into an analytical instrument having a rotary actuator, a heater, and a cassette receiver, wherein the test cassette comprises: a test cassette housing of a type suitable for receiving cassettes by a receiver of the analytical instrument and a port for receiving a heater of the analytical instrument; a first angular displacement sensor having a first detector and a first rotary element rotating about a first axis of rotation, wherein the first angular displacement sensor is located inside the test cassette housing such that the first rotary element engages with the rotary actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the rotary actuator of the analytical instrument, and wherein the first detector is configured to determine an angle through which the rotary element rotates about the first axis relative to the test cassette housing upon insertion of the test cassette into the analytical instrument and activation of the rotary actuator of the analytical instrument; and a temperature sensor having a receiving portion in the body of the test cassette and a temperature detector located inside the receiving portion, wherein the temperature sensor is located inside the body of the test cassette so that the receiving portion engages with the heater of the analytical instrument when the test cassette is inserted into the analytical instrument, wherein the receiving portion is intended for heating by the heater of the analytical instrument, and wherein the temperature detector is intended for determining the temperature inside the receiving portion.

[0139] Embodiment 22. The test cassette of embodiment 21, further comprising a second angular displacement sensor having a second detector and a second rotary member rotating about a second axis of rotation, wherein the second angular displacement sensor is located within the body of the test cassette such that the second rotary member engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the second detector is configured to determine a second angle through which the second rotary member rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated.

[0140] Embodiment 23. The test cassette according to any of embodiments 21-22, wherein the first axis of rotation and the second axis of rotation are parallel to each other.

[0141] Embodiment 24. A test cassette according to any one of embodiments 21-23, wherein the rotary member includes a shaft and elements for engaging with a rotary actuator of the analytical instrument.

[0142] Implementation 25. The test cassette according to any one of embodiments 21-24, wherein the first angular displacement sensor further includes an encoder disk having a central axis of the disk that is in line with the central axis of the rotary member and the first axis, and the first detector is an optical sensor for detecting the movement of the encoder disk.

[0143] Embodiment 26. The test cassette of any one of embodiments 21-25, wherein the first angular displacement sensor further includes a resistive element for applying a resistive force to the rotary element.

[0144] Embodiment 27. The test cassette according to any one of embodiments 21-26, in which the first angular displacement sensor further includes a friction element for contacting the rotary element and applying a frictional force thereto.

[0145] Embodiment 28. The test cassette according to any one of embodiments 21-27, in which the first angular displacement sensor further includes a resistive element arranged such that the friction element is located between the resistive element and the first rotary element, and the resistive element is designed to apply a force to the friction element along the axis of rotation in a direction toward the rotary element.

[0146] Implementation 29. A test cassette according to any of embodiments 21-28, wherein the receiving portion is made of metal.

[0147] Implementation 30. A test cassette according to any one of embodiments 21-29, wherein the receiving portion is configured to contact a heater inserted through the port.

[0148] Embodiment 31. The test cassette of any one of embodiments 21-30, wherein the receiving portion further includes a heating sleeve around the receiving portion, and the heating sleeve contacts a heater inserted through the port.

[0149] Implementation 32. The test cassette of any one of embodiments 21-31, further comprising a torque sensor for measuring the torque applied to the rotary member.

[0150] Embodiment 33. The test cassette according to any one of embodiments 21-32, further comprising a controller having one or more processors and one or more memory devices, wherein the controller is communicatively coupled to the first detector and the temperature detector, and the controller is configured to receive and store data generated by the first detector and the temperature detector.

[0151] Implementation 34. The test cassette according to any one of embodiments 21-33, further comprising a communication interface for transmitting data generated by the first angular displacement sensor and the temperature sensor.

[0152] Embodiment 35. The test cassette of any one of embodiments 21-34, wherein the communication interface is configured to transmit data generated by the first angular displacement sensor and the temperature sensor, the controller is configured to transmit data generated by the first angular displacement sensor and the temperature sensor to the analytical device, and the analytical device is configured to issue a notification based at least in part on the data generated by one or more of the first angular displacement sensor and the temperature sensor.

[0153] The use of ordinal indicators, such as (a), (b), (c) ... or the like, if any, in the present description and claims should be understood as not conveying any particular order or sequence, unless such order or sequence is explicitly stated. For example, if there are three steps designated as (i), (ii) and (iii), it should be understood that these steps may be performed in any order (or even simultaneously, unless contraindicated), unless otherwise stated. For example, if step (ii) involves processing the element created in step (i), then step (ii) may be understood as occurring at some point after step (i). Likewise, if step (i) involves processing the element created in step (ii), it should be understood as the reverse action.

[0154] It should also be understood that the use of the word “for”, for example, the expression “the gas inlet channel of the cassette is designed to receive gas from the temperature control system”, can be replaced, for example, by the combination “configured with the possibility”, for example, “the gas inlet channel of the cassette is configured to receive gas from the temperature control system” or the like.

[0155] Terms such as “about,” “approximately,” “substantially,” “nominal,” or the like, when used in relation to quantities or similar quantifiable properties, should be understood to include values within ±10%, ±5%, ±3%, ±1%, ±0.5%, ±0.1%, ±0.05%, or ±0.01% of the stated values, unless otherwise stated.

[0156] It should be understood that the phrases "for each <element> of one or more <elements>,""each<element> of one or more <elements>," or the like, when used herein, should be understood to include both a group of a single element and a group of a plurality of elements, i.e., the phrase "for... each" is used in the same sense as in programming languages to refer to each element of any subset of elements. For example, if the subset of elements referenced is a single element, then the term "each" will refer only to that single element (even though dictionary definitions of "each" often define the term as "each of two or more objects") and will not imply the presence of at least two of those elements.

[0157] It is to be understood that all combinations of the above concepts (provided that such concepts are not mutually contradictory) are considered to be part of the subject matter described herein. In particular, all combinations of claimed subject matter appearing at the end of this description are considered to be part of the subject matter described herein. It is also to be understood that terminology expressly used herein, which may also appear in any description incorporated herein by reference, shall have the meaning most consistent with the particular concepts described herein.

[0158] Although the concepts presented herein have been described with reference to the figures, it should be understood that many modifications and changes can be made by those skilled in the art without departing from the spirit of the description.

Claims (79)

1. A test cassette for insertion into an analytical instrument having a linear actuator, a rotary actuator, a heater, a pump actuator, a second linear actuator, and a cassette receiver, comprising: a test cassette body of a design suitable for receiving cassettes of an analytical instrument by a receiver; a plurality of first linear displacement sensors, wherein each of the first linear displacement sensors has a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a first portion of each of the plurality of first linear displacement sensors is located in the body of the test cassette so that its corresponding first movable element engages with the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument, and wherein each first detector of each of the plurality of first linear displacement sensors is designed to determine a first distance traveled by the corresponding first movable element along the corresponding first axis relative to the body of the test cassette in response to linear input data provided by the linear actuator of the analytical instrument upon insertion of the test cassette into the analytical instrument and activation of the linear actuator of the analytical instrument; a second linear displacement sensor having a second detector and a second movable element configured to move linearly along a second axis, wherein at least a second portion of the second linear displacement sensor is located inside the body of the test cassette so that the second movable element engages with the actuator of the pump of the analytical device when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated, and wherein the second detector is configured to determine a second distance traveled by the second movable element along the second axis relative to the body of the test cassette when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated; an angular displacement sensor having a third detector and a rotary element rotating about a third axis, wherein the angular displacement sensor is located inside the housing of the test cassette so that the rotary element engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the third detector is designed to determine the angle by which the rotary element rotates about the third axis relative to the housing of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated; a temperature sensor having a receiving portion in the body of the test cassette and a temperature detector located inside the receiving portion, wherein the temperature sensor is located inside the body of the test cassette such that the receiving portion engages with a heater of the analytical instrument when the test cassette is inserted into the analytical instrument, and wherein the temperature detector is designed to determine the temperature inside the receiving portion when the test cassette is inserted into the analytical instrument; and a plurality of load sensors, wherein each of the plurality of load sensors is located within the housing of the test cassette such that each load sensor engages with the second linear actuator upon insertion of the test cassette into the analytical instrument and activation of the second linear actuator of the analytical instrument, and wherein each of the plurality of load sensors is designed to determine a force applied to the corresponding load sensor upon insertion of the test cassette into the analytical instrument and activation of the second linear actuator of the analytical instrument. 2. The test cassette according to item 1, further comprising a controller having one or more processors and one or more memory devices, wherein the controller is connected with the possibility of transmitting data with each first detector of each of the plurality of first linear displacement sensors, the second detector of the second linear displacement sensor, the third detector of the angular displacement sensor, the temperature detector of the temperature sensor and each of the plurality of load sensors and the controller is configured to receive and store data generated by each first detector, second detector, third detector, temperature sensor and each of the plurality of load sensors. 3. The test cassette according to item 2, in which the controller is designed with the ability to transmit updated data on movement to the analytical device and the updated displacement data is at least partially based on one or more data generated by one or more of the first detectors, the second detector, the third detector, the temperature sensor, and each of the plurality of load sensors. 4. The test cassette according to item 2, in which the controller is configured to transmit data generated by the first detectors, the second detector, the third detector, the temperature sensor and each of the plurality of load sensors of the analytical instrument, and the analytical device is configured to issue a notification based at least in part on data generated by the first detectors, the second detector, the third detector, the temperature sensor and each of the plurality of load sensors. 5. A test cassette according to any one of claims 1-4, further comprising a communication interface for transmitting data generated by each of the plurality of first linear displacement sensors, the second linear displacement sensor, the angular displacement sensor, the temperature sensor and the plurality of load sensors to an external device. 6. The test cassette of claim 5, wherein the external device is an analytical instrument. 7. A test cassette according to any one of paragraphs 1-4, in which each of the plurality of first linear displacement sensors further includes a first force application element configured to apply a first resistive force to the first movable element along the first axis, and the angular displacement sensor further includes a second force application element configured to apply a second resistance force to the rotary element. 8. A test cassette according to any one of paragraphs 1-4, in which the angular displacement sensor further includes a friction element for contacting and applying friction force to the rotary element, the angular displacement sensor further includes a force application element arranged such that the friction element is arranged between the force application element and the rotary element, and the force application element is configured to apply force to the friction element along the third axis and in the direction of the rotary element. 9. The test cassette according to any one of claims 1-4, further comprising a second angular displacement sensor having a second angular detector and a second rotary element rotating about a second axis of rotation, wherein the second angular displacement sensor is arranged such that the second rotary element engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated, and wherein the second angular detector is configured to determine a second angle by which the second rotary element rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the actuator of the pump of the analytical instrument is activated. 10. A test cassette for insertion into an analytical instrument having a linear actuator and a cassette receiver, comprising: a test cassette housing of a type suitable for receiving cassettes by the receiver of the analytical instrument; and a plurality of linear displacement sensors, wherein each of the linear displacement sensors has a first detector and a corresponding first movable element configured to move linearly along a first axis, wherein at least a portion of each of the linear displacement sensors is located in the body of the test cassette so that its corresponding first movable element engages with the linear actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the linear actuator of the analytical instrument is activated, and each detector is designed to determine the distance traveled by the corresponding first movable element along the corresponding first axis relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the linear actuator of the analytical instrument is activated. 11. The test cassette of claim 10, wherein each linear displacement sensor further includes a force application element configured to apply a resistive force to the first movable element along the first axis in the first direction. 12. The test cassette of claim 11, wherein the force application element is a compression spring. 13. The test cassette of claim 10, wherein each linear displacement sensor further includes a contact portion with which the engaging pin of the linear actuator contacts. 14. The test cassette according to item 10, in which each moving element includes a strip of a code sensor and Each detector is an optical sensor for detecting the movement of the encoder strip included in the corresponding movable element. 15. A test cassette according to any one of paragraphs 10-14, further comprising a controller having one or more processors and one or more memory devices, wherein the controller is connected with the possibility of transmitting data with each first detector of each of the linear displacement sensors and the controller is configured to receive and store data generated by each first detector of each of the linear displacement sensors. 16. The test cassette of claim 15, further comprising a communication interface for transmitting data generated by each of the one or more first linear displacement sensors. 17. The test cassette according to item 16, in which the communication interface is configured to transmit data generated by each of the one or more first linear displacement sensors to the analytical instrument, the controller is designed with the ability to transmit calibration data to the analytical instrument and the calibration data is based at least in part on data generated by one or more first linear displacement sensors of the analytical instrument. 18. A test cassette for insertion into an analytical instrument having a pump actuator and a cassette receiver, comprising: a test cassette body of a type suitable for receiving cassettes of an analytical instrument by a receiver, a first opening and a second opening opposite the first opening, the second opening being intended for receiving a portion of the actuator of the pump of the analytical instrument; and a linear displacement sensor having a detector and a movable element configured to move linearly along a first axis, wherein at least a portion of the movable element is located inside the body of the test cassette in the test cassette, the movable element is located between the first opening and the second opening, the movable element is configured to engage and move a portion of the pump actuator inserted through the second opening, when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated and when the actuator of the pump is moved when the test cassette is inserted into the analytical device and the actuator of the pump of the analytical device is activated, wherein the movable element is configured to move through the first opening and the detector is configured to determine the distance traveled by the movable element along the first axis relative to the body of the test cassette. 19. The test cassette of claim 18, further comprising a controller having one or more processors and one or more memory devices, wherein the controller is connected with the possibility of data transmission to the linear displacement sensor detector and the controller is configured to receive and store data generated by the linear displacement sensor detector. 20. The test cassette according to claim 18 or 19, further comprising a communication interface for transmitting data generated by the linear displacement sensor. 21. A test cassette for insertion into an analytical instrument having a rotary actuator, a heater and a cassette receiver, comprising: a test cassette body of a type suitable for receiving cassettes of an analytical instrument by a receiver, and a port for receiving a heater of an analytical instrument; a first angular displacement sensor having a first detector and a first rotary member rotating about a first axis of rotation, wherein the first angular displacement sensor is located within the housing of the test cassette such that the first rotary member engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the first detector is designed to determine the angle by which the first rotary member rotates about the first axis of rotation relative to the housing of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated; and a temperature sensor having a receiving portion in the body of the test cassette and a temperature detector located inside the receiving portion, wherein the temperature sensor is located inside the body of the test cassette so that the receiving portion engages with the heater of the analytical instrument when the test cassette is inserted into the analytical instrument, wherein the receiving portion is intended for heating by the heater of the analytical instrument, and wherein the temperature detector is intended for determining the temperature inside the receiving portion. 22. The test cassette of claim 21, further comprising a second angular displacement sensor having a second detector and a second rotary element rotating about a second axis of rotation, wherein the second angular displacement sensor is located within the body of the test cassette such that the second rotary element engages with the rotary actuator of the analytical instrument when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated, and wherein the second detector is designed to determine a second angle through which the second rotary element rotates about the second axis of rotation relative to the body of the test cassette when the test cassette is inserted into the analytical instrument and the rotary actuator of the analytical instrument is activated. 23. The test cassette of claim 22, wherein the first axis of rotation and the second axis of rotation are parallel to each other. 24. The test cassette of claim 21, wherein the rotary member includes a shaft and elements for engaging with a rotary actuator of the analytical instrument. 25. The test cassette according to item 21, in which the first angular displacement sensor further includes an encoder disk having a central axis of the disk that is on the same line with the central axis of the rotary element and the first axis, and The first detector is an optical sensor for detecting the movement of the encoder disk. 26. The test cassette according to claim 21, wherein the first angular displacement sensor further includes a force application element configured to apply a resistive force to the rotary element. 27. A test cassette according to any one of paragraphs 21-26, in which the first angular displacement sensor further includes a friction element for contacting the rotary element and applying a frictional force thereto. 28. The test cassette according to item 27, in which the first angular displacement sensor further includes a force application member arranged such that the friction member is located between the force application member and the rotary member, and the force application element is configured to apply force to the friction element along the axis of rotation in the direction of the rotary element. 29. A test cassette according to any one of paragraphs 21-26, in which the receiving part is made of metal. 30. A test cassette according to any one of paragraphs 21-26, in which the receiving part is designed with the possibility of contact with a heater inserted through the port. 31. The test cassette according to item 30, in which the receiving portion additionally includes a heating cuff around the receiving portion and the heating cuff is designed to be in contact with a heater inserted through the port. 32. A test cassette according to any one of paragraphs 21-26, further comprising a torque sensor for measuring the torque applied to the rotary member. 33. A test cassette according to any one of paragraphs 21-26, further comprising a controller having one or more processors and one or more memory devices, wherein the controller is connected in a data-transmitting manner to the first detector and the temperature sensor and the controller is configured to receive and store data generated by the first detector and the temperature sensor. 34. The test cassette according to claim 33, further comprising a communication interface for transmitting data generated by the first angular displacement sensor and the temperature sensor. 35. The test cassette according to item 34, in which: the communication interface is configured to transmit data generated by the first angular displacement sensor and the temperature sensor, the controller is configured to transmit data generated by the first angular displacement sensor and the temperature sensor to the analytical instrument and the analytical device is configured to issue a notification at least in part based on data generated by one or more of the first angular displacement sensor and the temperature sensor.