FR3051046A1 - ALL-IN-ONE RAPID DIAGNOSTIC DEVICE ON BLOOD PRODUCT FOR QUALIFICATION OF BLOOD POCKET, OR TEST BEFORE SURGERY, OR DASHBOARD IN GENERAL MEDICINE - Google Patents

Abstract

The invention relates to a device (1) provided with an inlet for receiving blood or a blood component, of one or more chromatographic or immunochromatographic tests, in a sealed envelope avoiding the contamination of the nursing staff. According to variations of the invention, it can take various forms, it can be integrated directly into a blood bag (5), be compatible with various connections (2, 3, 4), or include a suction device to accelerate the chromatographic tests. The device according to the invention is particularly intended for general medicine, surgery, obstetrics, medical emergencies, and countries or organizations seeking security, rapid qualification, or reliable and economical traceability of blood bags.

Description

The present invention relates to a rapid diagnostic device all-in-one blood or blood component for blood bag qualification, or test before surgery, or dashboard in general practice.

In the field of public health, some international bodies recommend the completion of four minimum tests for microbiologically qualifying blood for blood transfusion: search for HIV antibodies, hepatitis C, syphilis, and search for hepatitis B antigen. In addition, the immunological qualification of the blood before transfusion requires at least one ABO and Rh grouping.

When an individual presents himself to donate his blood, a blood bag is taken, and several blood tubes are taken at the same time and then disconnected from the blood bag for qualification tests. These tests take place in a nearby room or in remote laboratories depending on the country or the organization. Depending on the result of the tests, a traceability system makes it possible to qualify or not the blood bag to be transfused, and the grouping ABO and Rhesus D is labeled on the pocket. Unqualified blood bags are destroyed.

In countries with poorly developed health and IT logistics infrastructures, tests are often performed in a nearby room, by manually taking blood drops from the blood tube, which the operator records on rapid diagnostic tests, including results are visible in less than 10 minutes. For the microbiological qualification tests and the ABO or Rhesus D grouping tests, these are immunochromatographic tests based on the antigen-antibody combination of the same nature as the recent HIV or hepatitis C self-tests known to the general public, and whose technique is well known to those skilled in the art.

In countries with advanced logistics, health, IT, and technical infrastructure, the donor may choose to donate blood or blood components directly, such as plasma and platelets. The tests can be adapted to the sampled component. Whatever they are, they are often made in remote laboratories according to dedicated techniques, also well known to those skilled in the art. Human intervention is almost zero and all operations are automated to reduce traceability errors.

The non-limiting disadvantages of these blood qualification systems are as follows: - The traceability system is expensive, - The traceability system is weak in developing countries where many labeling errors are reported, - The qualification system requires a lot of manual or automated operations that generate either a lot of errors or significant costs, - The qualification system is not instantaneous while one may wish to collect and transfuse in stride, - In In some countries, a significant portion of the bags collected is contaminated, leading to additional costs and health problems.

The device according to the invention overcomes these disadvantages. Indeed, the device contains according to a first feature a single input for receiving a small amount of blood or blood component. According to a second characteristic, it contains a chromatographic or immunochromatographic test. According to a third characteristic, the blood is confined in the device to ensure the safety of the nursing staff.

According to particular embodiments, the device according to the invention can: - have a sampling needle, or a connection tip for a catheter, or a connection system for sampling body, - be under vacuum or comprise a suction device to accelerate the diffusion of the liquid in the chromatographic or immunochromatographic test, contain an anticoagulant, contain a filter passing the plasma, the filter being monolayer or multi-layer, the filter may be common to several tests, contain immuno-chromatographic tests for the detection of AIDS, hepatitis C, syphilis, hepatitis B, ABO grouping, Rhesus D, chikungunya, malaria, dengue, CMV, or of ebola, this list being non-limiting. - be directly integrated into a blood or blood component bag.

The attached drawings illustrate the invention: FIG. 1 represents various nonlimiting modes of use of the invention: the first drawing illustrates the device (1) directly connected to a sampling needle (2), the assembly forming a ideal autonomous test in general medicine. The second drawing shows an arm in which has been stitched a twin-port finned catheter (3), whose patients are often provided in hospital, the device (1) is then provided with the corresponding connection, which makes its rapid use , without the patient needing another sting. The third drawing shows a conventional configuration where the patient is already provided with a catheter with sampling body (4), the device is then provided with a corresponding connection system. The fourth drawing shows a blood bag (5) to which the device (1) is integrated. The fifth drawing shows another blood bag (5) to which the device (1) is integrated in the blood bag (5) integrally to exclude any traceability problem. - Figure 2 shows, from the front and in section, a first embodiment of the device (1) according to the invention, including 6 tests (11) immunochromatography. On the right is the entrance (12) for receiving the blood, and a transparent plastic envelope (14) ensuring the safety of the nursing staff. FIG. 3 represents, from the front and in section, a second embodiment of the device (1) according to the invention, characterized in that the rapidity of the test is accelerated by placing the assembly under vacuum, so that when the device is connected to the blood or blood component, the liquid is drawn into the chromatographic tests (11). FIG. 4 represents, in section, a third embodiment of the device (1) according to the invention, particularly adapted to the sampling bodies (4), or the device (1) takes the form of a tube (19) equipped with a chromatographic test (11), the entry into the device (1) is then a plug (20) of rubber.

The different embodiments described are non-limiting; their function is to better understand the invention.

As illustrated in Figure 3, a particular non-limiting embodiment of the device (1) according to the invention consists of a plate (15) of polyethylene of 0.5mm thick thermoformed with 6 footprints 3cm in length, 0.5cm wide, and 1mm deep. 6 tests (11) immunochromatographic technique known to those skilled in the art, 3cm in length, 0.5cm wide, and 1mm thick are placed in the fingerprints: HIV antibody, hepatitis C antibody, siphilis antibody, Hepatitis B antigen, AB antigen, Rhesus D. The 6 tests (11) have a result area, totally white before use. After use, for each of the first four tests, 1 to 2 colored lines are displayed in the result area: a control line, which defines whether the test is valid or not, and a line that defines whether the blood is healthy or no. For the ABO grouping test (11), 1 to 3 colored lines are displayed after use: the control line which defines whether the test (11) is valid or not, the line A, and the line B, which qualifies the donor group. For the rhesus test (11), 1 to two red lines are displayed: the control line that defines whether the test (11) is valid or not, and a line that defines the rhesus grouping of the donor. A plastic film, not shown, maintains the bottom end tests (11) in their position. On the upper end of the tests (11) is affixed a filter (13) 1 cm wide and 5 cm long, multi-layer, allowing the plasma to pass but not the red blood cells, well known to those skilled in the art. This filter was soaked and then sprinkled with lithium heparin to prevent coagulation. At two tests (11), the grouping ABO and the rhesus D, 2 holes (16) calibrated 100 microns section are drilled in the filter. A form (17) of thermoformed polyethylene, the central portion of which has a circular cord 6mm wide by 2mm in height, and whose sides are flat areas 5mm wide, is sealed on the edges of the filter (13). ). In the middle of this tunnel form has been thermoformed a nozzle section of 2.2mm, or is sinking a hose (12) flexible pvc 2mm section. The assembly is enclosed in a transparent pocket (14) sealed so as to avoid any contamination with the outside. The device has been shown here provided with a sampling needle (2), but it can be provided with a connection to be attached to any object containing blood or a blood component.

To use this device (1), it should be arranged vertically on a dedicated support provided with it, or let it hang by the pipe of the inlet (12). When this device (1) is supplied with blood, the blood fills the form (17) in a thermoformed tunnel. The filter (13) passes the plasma but does not pass the cellular elements of the blood. The plasma diffuses in the first four tests (11), and the control lines become colored, confirming the validity of the test (11), while the other lines become colored only if the blood carries the disease to be detected. For both rhesus blood pool tests, the plasma diffuses through the filter (13), and a minimal flow of red blood cells passes through the holes (16). These 2 tests (11) are fed with a mixture of plasma and red blood cells, with concentrations according to the recommendations of the supplier of these tests (11). The control lines become stained, confirming the validity of the test (11) while positive A, B, and rhesus lines become so only if the blood carries the corresponding antibodies.

The tests (11) used here are recommended for a reading between 5 minutes after the test and 30 minutes after, even if the test result (11) is still readable for several weeks, but with increasingly blurred lines. An operator ticks the results of the test (11) in this time interval recommended on a sticker supplied with the device (1), so as to maintain the results in a sustainable manner. The device (1) with its results can also be photographed during this time interval, and the printed photo is glued to the device (1), or the corresponding blood bag (5) corresponding to transfuse, or on the donor's file, where the photo is analyzed by a computer system and then computerized the results.

According to a second embodiment illustrated in FIG. 3, the device (1) according to the invention is made as follows: on a transparent flexible plastic film (14) of 6cm by 6cm, there are 4 tests (11) HIV antibodies, hepatitis antibodies C, syphilis antibody, and hepatitis B antigen. On the high end of these four tests (11), there is a filter (13) permeable to particles smaller than 2 microns, 1 cm wide and 5 cm in length, and sealed to another transparent plastic film (14) 6cm by 6cm, the plastic film being hollowed out of a rectangular shape corresponding to the filter (13). A T-shaped plastic, not shown here, is affixed between the tubular inlet (12) and the filter (13). This T-shape is sprinkled with anticoagulant. We place a third plastic (14) transparent 6cm by 6cm. The three transparent plastic films are sealed (18) on the four edges, and around the tubular entrance. The void is created between the two outer plastic films (14). The residual pressure in the device is of the order of 100mbar. The inlet (12) is connected to a pipe, not shown here. The pipe is connected to a valve adapted to a catheter (3) illustrated in Figure (1). The valve, according to techniques known to those skilled in the art, preserves the vacuum in the device (1) as long as the valve is not connected to the catheter.

This embodiment is particularly suitable for the case where it is a question of having a rapid diagnosis on a patient already provided with a catheter (3) with fin stitched for example in the arm. The staff then screws the device valve (1) to the catheter socket (3). The valve is open upon connection, and the vacuum in the device (1) creates a suction force that sucks the blood to the filter (13) and the plasma through the filter (13) to the tests (11). The T-shape allows blood to be safely distributed to all four tests (11).

According to this embodiment, the results of the tests (11) are obtained more rapidly; With some commercial chromatographic tests (11), the results can be obtained in about one minute.

A variant of this embodiment consists in adding an open-cell elastic shape to the lower end of the tests (11); this makes it possible to adjust the desired suction volume.

According to a third non-limiting embodiment, illustrated in Figure 4, the device (1) according to the invention consists of a tube (19) made of plastic, provided with a plug (20) rubber shutter. Inside the tube (19), there is a filter (13) in the form of a sleeve, the filter (13) passes the plasma but does not pass the cell elements of the blood. The multilayer filter (13) was previously impregnated with an anticoagulant. There is also a small amount of anticoagulant inside the sleeve formed by the filter (13). The plastic tube (19) is provided at the base with a hole (21) of about 2 mm in diameter, in front of which an immunochromatographic test (11) is available. In this variant, it has been used. Hepatitis C. A flexible plastic film (14) surrounds the tube and is sealed at the top of the tube (20), and vacuum is created throughout the device (1).

In the non-limiting variants of this embodiment, an open-cell elastic shape is added to the upper end of the test (11) to adjust the desired suction volume. There are also around the tube (19) as many tests (11) as you want. Another alternative is to use an unperforated glass tube (19), and the test (11) is placed inside the tube (19). When the tube (19) is not pierced, the tube (19) plays the role of the waterproof protective envelope that secures the nursing staff.

This embodiment is particularly suitable for sampling bodies (4) used in hospitals today. The patient is for example already provided with a catheter and a sampling body (4). The doctor needs a quick diagnosis. It introduces the tube (19) provided with the test (11) in the sampling body (4), which pierces the closure plug (20). The patient's blood is drawn through the vacuum into the tube (19), and the blood mixes with the anticoagulant. The plasma passes through the filter (13) and then continues to be drawn through the immunochromatographic test (11). In a few minutes, the doctor has the results of the tests (11) chosen.

The three embodiments that we have just described and their variants are non-limiting illustrations of the invention.

The device (1) according to the invention is particularly intended: - to perform an instant qualification test before possible blood sampling in areas where contaminated blood bags to be destroyed constitute a financial and sanitary problem, - to be routinely added to the pockets of blood to become the system of qualification and traceability of blood bags, - to serve as an instant test before transfusion for any doubtful pocket, especially in countries where traceability is doubtful. - to act as an instantaneous test before any surgery for the surgeon to take the associated precautions, - to serve as a rapid diagnostic test secure for general practitioners, or in emergency medicine, or in various specialties such as obstetrics.

Claims (10)

1) Device (1) for rapid diagnosis on blood or blood component, characterized in that it contains an inlet for receiving blood or a blood component, for example a tubular inlet (12) or a rubber stopper (20). ) pierceable, at least one chromatographic or immunochromatographic test (11), and a tight envelope confining the blood in the device, for example a plastic film (14) or a tube (19). 2) Device (1) according to claim 1 characterized in that it also comprises a sampling needle (2), or a connection tip for catheter (3), or a connection system for sampling body (4). 3) Device (1) according to one of the preceding claims, characterized in that the interior of the device (1) is under vacuum or in that the device (1) comprises a suction device for accelerating the diffusion of the liquid in the chromatographic or immunochromatographic test (11). 4) Device (1) according to one of the preceding claims, characterized in that it contains a filter (13) allowing the plasma to pass but not passing the cell elements of the blood, the filter (13) being monolayer or multilayer , the filter (13) being common or not to several tests (11). 5) Device (1) according to one of the preceding claims, characterized in that it contains an anticoagulant, for example disposed upstream of a filter (13) or a filter (13) is imbibed. 6) Device (1) according to one of the preceding claims, characterized in that it contains at least tests (11) immunochromatographic detection of the AIDS virus, hepatitis C, syphilis, and hepatitis B. 7) Device (1) according to one of the preceding claims, characterized in that it contains tests (11) for grouping ABO and rhesus D. 8) Device (1) according to one of the preceding claims characterized in that it contains one or more tests (11) among Chikungunya, malaria, dengue, CMV, ebola. 9) Device (1) according to one of the preceding claims directly integrated in a pocket (5) for collecting blood or blood component. 10) Assembly incorporating at least one bag (5) for collecting blood or blood component and a device (1) according to one of the preceding claims.