WO1998010283A1 - Sample protective container integral with body fluid separating sheet - Google Patents

Abstract

A container adapted to measurably separate a small or very small quantity of body fluid, especially, blood, and transportable simply, safely and stably. This sample protective container is characterized in that it has (a) a region capable of adsorbing a body fluid to be examined, especially, blood, (b) a region enabling the adsorbed body fluid to be subjected to a pretreatment based on the principle of chromatography, and (c) a region enabling components of the chromatographically separated body fluid to be held in a separated state, and at least the region (c) is protected. Especially, a sheet type container in which a blood separating sheet is protected by a substrate sheet by which the blood separating sheet is fixed and a sheet covering a section holding separated blood serum components is easily handled.

Description

 Description Specimen protection container integrated with body fluid separation sheet

 The present invention relates to a container capable of separating a small amount or amount of bodily fluid in a measurable manner and capable of carrying it easily, safely and stably, and a method therefor. More preferably, the present invention provides a container capable of measurably separating blood into a clot and a serum and transporting the separated components while maintaining a measurable state, and a method used therefor. About. According to the present invention, there is provided a method for measuring the blood of ί¾ * so as to measurably separate the blood cell component from a blood cell component, and to maintain the separated components in a measurable state. , And / or transport or store. In addition, the present invention relates to a storage container for a sample after blood separation, which is used when a clinical institution is outsourced from a medical institution (clinic room) to a laboratory (inspection room) in a clinical test.

 ADVANTAGE OF THE INVENTION According to the present invention, it is possible to examine a component in the blood from a relatively small amount or a body fluid, more preferably from an ear collection fluid when only a single drop or two drops are obtained, such as an infant. Thus, it is possible to easily separate it into a blood clot or the like, which mainly contains blood cell components such as red blood cells, and a serum or plasma component.

 According to the present invention, it is possible to separate into a blood clot and a serum component mainly containing blood cell components without adding a liquid coagulant or the like to the blood for the test, and to transport the separated blood to the test facility in a separated state. And In addition, laboratories can easily secure the required volume for measurement or inspection. In addition, if necessary, the blood is treated with a liquid coagulant or the like, separated into blood cell components and plasma components, and kept in a separated state. Can be moved to or saved.

According to the present invention, by cutting out and using sheet fragments of an appropriate length, the required amount of the test sample component can be easily adjusted, and the collected blood is subjected to physiological analysis so as to be suitable for test measurement. Adjust the concentration by diluting with food or buffer solution. It can save troublesome work. Background art

 To date, various measurement tests have been developed using blood, saliva, urine, cerebrospinal fluid, ascites, tears, and other body fluids for diagnostic purposes, and are widely used to prevent, diagnose, and treat diseases. Have been. Above all, in recent years, a relatively small amount or only a small amount has been obtained, and various measures have been devised so that such measurement tests can be performed efficiently using body fluids, and research and development have been carried out to obtain reliable measurement results. I have. Since blood circulates through the body, it contains components that reflect various symptoms of the body.By measuring and testing various components contained in the blood quickly and quickly, Diagnosis of illness etc. can be performed quickly and accurately, and it can be used for the prevention and treatment of the disease.

 Conventionally, when a clinical test is performed using a component sample such as blood collected from the human body, the collected blood is first treated with anticoagulant such as heparin, sodium EDT, sodium citrate and the like. It is mixed with the drug, and the blood plasma component is separated by centrifugation to obtain the sample, or the blood cell component is coagulated without mixing with the anticoagulant, and the serum component is separated by centrifugation to obtain the sample, such as glass or plastic. They were dispensed into Spitz, stored at different storage temperatures, and sent to an inspection organization (inspection hall).

 In such a case, (1) the operation of separating the sample components from the blood, (2) the operation of separating the sample components and dispensing them into a storage container, (packing and transporting according to the conditions of room temperature, refrigeration, and freezing, which are the IM superficial temperatures) Was sent to the inspection organization (inspection hall).

 By the way, the components in blood are usually measured and separated into blood clots and serum components, and then a measurement test suitable for each component is performed. When blood is collected, the blood cell components immediately form aggregates (blood clots), but these aggregates may take up specific serum components and affect the measurement results, It is generally desirable to perform such separations as soon as the blood is collected, since some of them may lyse and interfere with the measurement of components in the serum.

Serum from blood in particular is a frequently used and important sample for such analyses. This serum is usually sent to a hospital and used for a special sterile blood collection or blood collection. Vein puncture was performed using a set to collect at least 5 cc or more of blood and then centrifuged under cooling to obtain its serum components. Such a method requires specialized techniques and requires a dangerous venipuncture in some aspects, and furthermore requires a centrifugal separator, which is practically infeasible outside hospitals and is very inconvenient. In addition, since a blood collection tube (test tube) is used, the sample is bulky, and the sample is stored in a liquid state or transported, so that handling is inconvenient. In the analysis and measurement using many serum samples, a small amount of serum, for example 1 to 5 to 1/10 of the amount of MJ ^ per drop of blood, is sufficiently measured. The ability to collect a small amount of blood easily and without difficulty and to use it for various measurement tests without the need for unnecessary invasion and other problems is required. .

 There is also a strong demand for such a small amount of blood samples to make it easier to handle ^ * number of samples more easily in hospitals, or to enable individuals to easily collect blood. . Infants and infants have special requirements for blood collection, and it is difficult to collect blood using a standard iinffl device, and only one drop using a disposable blood collection device called a “lancet”. Can usually collect only a small amount of blood from two drops

(For example, Toya Masayuki, Inspection and Technology, Vol. 23, No. 8, pp 61-605, 1995). It is practically impossible to subject the whole blood thus obtained to separation means such as centrifugation, and therefore cannot be separated into blood clots and blood serum mainly containing blood cell components. It was virtually impossible to perform normal laboratory measurements using the resulting serum samples.

In recent years, the amount of specimens used in clinical tests has been miniaturized due to the high precision and high sensitivity of test methods. Among them, a body fluid material such as blood or serum is cut into a filter paper cut to a certain size according to the test item, so that it is infiltrated into a sample, and blood components and coagulation components that have clotted during the test are removed, and serum components are removed. A simple method is used as a test material, and filter paper containing such blood is used as a specimen. In such a case, if the sample supported on the filter paper is blood, blood cell components and serum It is possible that some inconveniences may occur depending on the inspection items. In the case of using filter paper carrying serum and plasma components, there is still a problem that it is necessary to separate the blood components (for pretreatment).

 When blood is used as the specimen, the blood (whole blood) is separated into blood clots such as blood cell components and serum, and the force used for each measurement test <. Such separation processing can basically be performed after blood collection. It is better to perform as soon as possible, and it is possible to obtain measurement results and clinically significant results.Power <known power <, since such separation was only possible by centrifugation, It was time-consuming and unsatisfactory. Perform measurements on multiple test items using a single sample.ii) The separated blood cell components and plasma components or serum components should be kept under the same conditions until they are measured and tested. Power <, which is good for evaluating subsequent Ito Yoshika, but until now this was not practically possible.

A sample that is collected and then undergoes substantially no alteration, etc., until it is measured or tested, and must be kept in a more stable form.In particular, liquids such as body fluids are susceptible to such alterations. It is difficult to maintain the same state as when it was performed, and it is required to be able to hold the body fluid sample in a more stable form (eg, Kiyoto Eiraku et al., Pediatrics, V o L 1 2, NO. 8, p 1 287-1 297, i 980; bill Teruo et al., Pediatric endothelium, Vol. 12, No. 8, p 1 265-1 2 7 0, 1 980 years') _c;

 There was a need for a method of separating a small number of specimens from a clot composed of blood cell components, etc. and a serum component by a simple operation.

In addition, as described above, blood is collected in a plastic blood collection tube using a disposable liaffl disposable measuring instrument, allowed to stand at room temperature for a certain period of time, and then centrifuged with a cooling centrifuge to separate the clot portion from the serum portion. Then, the serum part obtained as the supernatant was separated into another test tube, etc., but the blood collection tubes and test tubes used for such ^ are consumed in large quantities and are bulky. Is contaminated by blood, and disposal as waste is a problem. Furthermore, since blood samples are stored and transported as a liquid, there is another problem in that they have an intention to handle them. Recently, each sample is accompanied by basic information such as the name, age, and gender of the subject, and information such as test request items. The power that is automatically managed and inspected using a computer together with this kind of automation is further required, and a suitable, high-density, high-amount It is also required to develop containers that are suitable for Disclosure of the invention

 The present inventors have determined that a blood serum that can be collected only in a small amount, such as a blood sample from an infant or an elderly person, or a blood sample that can be collected by an individual, and then a serum or sample for the sample can be obtained by a simple method. As a result of diligent research, it was determined that plasma could not be prepared, and that it was easy and safe to use even small amounts of samples, and that it could be stably held and carried. It has been found that using a separation sheet not only allows serum and Z or plasma to be easily separated from whole blood, but also allows the separated serum, Z or plasma to be retained until stable measurement. In addition, the present inventors can easily handle the ¾ftiii solution, and can easily transport and handle the ¾ftiii solution, and at the time of measurement, only the sheet portion of the serum portion or only the sheet portion of the plasma portion. The present invention has been found to be able to cut out the sample and use it for the measurement, to obtain good 沏 j results with such a method, and to be able to easily adjust the amount of the sample used for the test. That is, the present invention

 [1] (a) An area where the bodily fluid to be separated can be penetrated and Z or adsorbed,

 (b) an area allowing the permeated and Z or adsorbed body fluid to undergo a separation process according to the principle of mouth chromatography; and

 (c) An area that allows components in the body fluid that has undergone chromatographic separation to be retained in a separated state

A sample protection container characterized in that at least the area of (c) above is protected.

[2] Apply the bodily fluid to be separated. The area (a) that has been subjected to force separation should be oriented in a direction perpendicular to the direction in which the separation is performed by one principle of chromatography. The sample protection container according to the above (1), which is configured to be able to apply a body fluid,

 [3] Chromatography--protection of components in body fluids that have undergone separation <to prevent contamination in a separated state (characterized by means of sufficient structure) The sample protection container according to the above [1] or [2],

 [4] Protection is provided in such a manner that the components in the body fluid subjected to the chromatographic separation are kept in a separated state, in a form that does not substantially cause exposed portions. The specimen protection container according to any one of the above (1) to (3),

 (5) The specimen protection container according to any one of (1) to (4) above, wherein the protection is performed by covering or by a casing.

[6] Protecting power \ The sample protection container according to any one of the above [1] to [5], which is provided by covering a sandwich type with a sheet.

 [7] The protecting force according to any one of the above [1] to [6], wherein the sample protecting container is detachable,

 [8] The specimen protection as described in any one of the above items U] to [7], wherein the protection means comprises two sheets, one of which has an adhesive surface at least in part. Container,

 [9] Ensure that the protection means is composed of two sheets, one of which is a sheet constituting the base, and which has an adhesive surface that can be repeatedly adhered or peeled on at least a part thereof. Any one of the above-mentioned (1) to (8), the specimen protection container according to (1),

 [10] A protective means is composed of two sheets, one is at least partially composed of an iSo visible sheet, and the other is at least partially a sheet having an adhesive surface that can be repeatedly adhered or peeled off. The sample protection container according to any one of the above (1) to (9), which is characterized by being constituted by

(11) The regions (a), (b) and (c) described in the above (1) are powerful, because whole blood is separated into components such as blood cells and serum components or plasma components by one principle of chromatography. A specimen protection container according to any one of the above (1) to (10),

 [1 2] Above description [1: Areas described (a), (b) and (c) Force Properties that allow whole blood to be separated into components such as blood cells and serum or plasma components by one principle of chromatography. The specimen protection container according to any one of the above (门 to U 1), which is a sheet having

 [1 3] The above [1] to [1], wherein the regions (a), (b), and (c) in which the words (1), (2), and (3) have the characteristics of a directional separation sheet. 1 2) The sample protection container according to any one of

 [14] The regions (a), (b) and (c) described in [1] above can strongly separate whole blood into components such as blood cells and serum components or plasma components by one principle of chromatography. A sample protection container according to any one of the above (1) to (13), wherein the sample protection container is a sheet having properties, and has properties of a force-directed separation sheet.

C 15] A sample protection container characterized in that the directional separation sheet for blood is protected,

 [16] The above-mentioned [15], wherein the directional separation sheet is characterized in that it can separate whole blood into components such as blood cells and serum components or plasma components by one principle of chromatography. ] Described sample protection container,

 [17] The directional separation sheet is developed by chromatography in a substantially specific direction from the site for receiving the test blood to convert whole blood into a clot component and a serum component or a blood cell component and a plasma component. The specimen protection container according to the above (15) or (16), which has a property capable of being separated.

 [18] The above-mentioned [15] to [15], wherein at least a region of the directional separation sheet that retains a serum component separated from blood or a blood plasma component separated from blood cells is protected. 1 7) any of the following,

 [19] The means for protecting the serum component or plasma component holding region of the directional separation sheet has a structure sufficient to prevent contamination of the serum component or plasma component. The specimen protection container according to the above (18),

[20] a serum component holding region or a plasma component holding region of the directional separation sheet The sample protection container according to the above (18), wherein the means for protecting the sample has a structure sufficient to prevent the serum component or the plasma component from drying.

 [21] The directional separation sheet and the serum component holding area of the directional separation sheet are sufficiently large that the means for protecting the plasma component holding area can be easily cut by a scissor. (18) The sample protection container according to (18),

 [22] Any one of the above [15] to [21], wherein the directional separation sheet has a strip structure that is long in the direction of movement of the sample based on the principle of chromatography 离! ^. Sample protection container,

 [23] The directional separation sheet is sandwiched between the upper and lower two sheets, and the directional separation sheet exists in a form that is divided into a part that receives blood and a part that holds separated serum or plasma. The specimen protection container according to any one of the above (15) to (22), wherein

 [24] In one of the two sheets sandwiching the directional separation sheet,

 (a) the part covering the blood receiving part and the part covering the serum or plasma retaining part are detachably attached to each other, or

(b) The part that receives the blood and the part that retains the serum or blood are integrated into a sheet that covers the part, and has an opening at the part that receives the blood to allow blood to be received. are doing

The specimen protection container according to the above (23), which is characterized in that:

 [25] The above-mentioned [23] or [23], wherein the upper and lower two sheets sandwiching the directional separation sheet are adhered to each other via an adhesive surface to protect the directional separation sheet. 2 4) Sample protection container described in

 [26] The regions (a), (b) and (c) described in [1] above and the directional separation sheet described in [15] provide wettability exceeding 65 dynes Z cm. The specimen storage according to any one of the above-mentioned [1] to [25], which has a fiber structure having a critical value of surface tension (critical value of surface tension imparting wettability) that can be applied. Protective container,

[27] The above-mentioned U] (a), (b) and (c) and the above: 15 :: The directional separation sheet described has a fibrous structure having a surface tension critical value of more than 65 dynes / cm, and the amount of fibers contained in the compact with respect to the force and the volume of the final compact. The specimen protection container according to any one of (1) to (26), wherein the volume ratio is 0.2 or more,

 (28) The specimen protection container according to (26) or (27), wherein the average diameter of に お け る in the fiber structure is about 3 m or less.

 [29] »The specimen protection container according to any one of the above [26] to [28], wherein the fiber structure comprises at least one fiber web layer;

 [30] Any one of the above-mentioned [26] to [29], wherein the sheet is a mat-like sheet that is stretched so as to have directionality. Described sample protection container,

 [31] The specimen protection container according to any one of [26] to [30], wherein the surface of ¾ is modified so that a carboxyl group and a hydroxyl group are mixed. ,

 [32] the sample protection container according to any one of the above [26] to [31], wherein the porosity force in the fiber structure \ is sufficient to fill the received blood sample.

 [33] Any of the above-mentioned [: 26] to [32], wherein the fiber has a structure graphed so as to present a hydroxyl group on the surface of the fiber. The specimen protection container according to

 (34) The fiber strength <the above-mentioned (26) to (33), wherein the sample protection container according to any one of (26) to (33), comprising a synthetic polymer fiber.

 [35] the specimen protection container according to any one of [26] to [34], wherein the fiber is made of polybutylene terephthalate;

 [36] The inspection according to any one of [26] to [35], wherein the fiber has a critical value of surface tension for imparting wettability of more than 65 dynes / cm. Body protection container,

[37] The area described in the above [1] (a), (b) and (c) and the above [15] The directional separation sheet force described in the above <, giving a wettability exceeding 65 dynes Z cm To do It is made of a fiber structure having a critical surface tension value (criticality of wettability-imparting surface tension) that can be obtained. Further, the area (b) described in the above [1] and the directional separation sheet described in the above [15] A force that allows the passage of serum or plasma into the sample <has an action to prevent the passage of red blood cells! ^ 蒦 The specimen protection according to any one of the above (1) to (3), characterized by having a layer container,

 [3 8] The sample protection container described in the above [3 7] [3], characterized in that the layer strength <porous.

 [3 9] The sample protective container according to [3 7], wherein the ^ ΙΪ layer is a microporous membrane.

 [40] The specimen protection container according to [39], wherein the microporous membrane is a polyamide.

 [41] The specimen protection container according to [40J, wherein the polyamide is selected from nylon 6, nylon 66, and nylon 61.

 [42] the specimen protection container according to the above [39], wherein the surface of the microporous membrane is a vascular resin membrane;

 [43] The specimen protection container according to the above [42], wherein the vein resin film is a fluorinated carbon resin film.

 [44] The regions (a), (b), and (c) described in the above [] and the directional separation sheet described in the above [15] have a wettability-imparting surface tension critical value exceeding 6 dynes and cm. And a strong tube suction force suitable for retaining serum or plasma in the area (c) described in [1] above and the directional separation sheet described in [15] above. The specimen protection container according to any one of the above UJ to 3], wherein the sample protection container has a structure having

 U5] The specimen protection container according to the above-mentioned [44], wherein the structure having a strong capillary suction force is a microporous membrane.

 [46] the specimen protection container of the above-mentioned [45], wherein the microporous membrane is a polyamide;

[47] The specimen protection container according to the above [46], wherein the polyamide is selected from the group consisting of nylon 6, nylon 66 and nylon 61. [48] the specimen protection container according to the above [45], wherein the surface of the microporous membrane is a hydrophilic resin membrane;

 [49] the sample protection container according to the above [48], wherein the hydrophilic resin film is a hydrophilic fluorocarbon resin film;

 [50] Any one of the above [门 to [4], characterized in that it is protected so that it can be stored, moved or transported, and that it is provided with Z or a management information symbol. Sample protection container,

 [51] Any of the above [门 to [50], characterized by being for a sample for analysis, testing or measurement, and / or being provided with a management information symbol therefor. A sample protection container according to

 [52] Any of the above-mentioned [1] to [51], characterized in that it has the ability to separate components in the sample and that it contains Z or an anticoagulant. Sample protection container described in Kao

 [53] (a) Apply the body fluid for measurement to the area where the body fluid to be separated and treated is infiltrated and Z-adsorbed,

 (b) subjecting the applied bodily fluid to a separation process according to a chromatographic principle, through a region enabling the bodily fluid to undergo a separation process according to a chromatographic principle;

 (c) the components in the bodily fluids that have undergone the chromatographic separation are then retained in an area that allows them to be retained in a separated state; and

A method for protecting a measurement sample, which comprises protecting at least the area (c).

[54] The method of the above-mentioned [53], wherein the body fluid to be separated is applied in a direction perpendicular to the direction in which the separation is performed according to the principle of chromatography.

 (55) The sample protection container according to any one of the above (1) to (52) contains a measurement body fluid, performs a separation process of the body fluid, and holds the components in the body fluid in a separated state. The method according to the above (5 3) or (5 4), wherein

[56] Penetrate and Z or adsorb the test blood on the directional separation sheet, and Characterized in that the whole blood is separated from the blood clot and serum component or the blood cell component and plasma component by chromatographic development in substantially one specific direction from the adsorption site and the adsorption site. 3)-Any one of [5 5]

 [57] The upper and lower sheets sandwiching the directional separation sheet are adhered to each other via an adhesive surface to form a covering structure to protect the directional separation sheet, and In one of the two sheets sandwiching the packet, the portion that covers the portion that receives blood and the portion that covers the portion that holds serum or plasma can be attached and detached independently of each other. At the time of measurement, the coating sheet covering the portion holding the serum or plasma is removed, and a required portion is cut out from the portion holding the serum or plasma of the directional separation sheet, and A method characterized by using blood serum or plasma obtained by cutting out for measurement,

 [58] Serum or plasma retained on the directional separation sheet, and the serum retention if ^ feX is used to retain the serum of the directional separation sheet after removing the coating sheet covering the plasma retention site. A test serum or plasma-containing sample obtained by treating the cut-out portion or the plasma-retaining site with a serum extraction medium or a plasma extraction medium, and using the thus obtained serum-containing sample or plasma-containing sample for measurement. How to use plasma samples,

 [59] After separating the serum portion retained on the directional separation sheet from the blood area containing other llll sphere components, perform a test or (± a test serum sample characterized in that it is used for measurement. How to use

 [60] A method for using a test plasma test sample characterized in that the plasma portion held on the directional separation sheet is separated from a region containing other blood cell components, and then used for testing or measurement.

 [61] The serum portion or the plasma portion held on the directional separation sheet is cut into a predetermined size in accordance with the size of the directional separation sheet, and the amount of the serum sample or the plasma sample is cut. A method for using a test serum or plasma sample, characterized in that the amount is determined and used; and

[62] The amount of serum or plasma sample required for measurement or analysis is determined by the thickness and width of the directional separation sheet of In accordance with the length of the directivity separation sheet. J 3 The method of using serum or plasma samples for testing. In a more specific aspect, the present invention provides:

 [63] A strip-shaped blood separation sheet is fixed on a base sheet, and the blood separation sheet is

 (a) an area for penetrating and / or adsorbing the blood to be separated and

(b) subjecting the permeated and / or adsorbed blood to a separation treatment by one principle of chromatography and dividing it into a region for holding the separated serum or plasma, and at least a region of the above (b) with a protective sheet A sample protection container characterized by being protected,

 [64] A strip-shaped blood separation sheet is fixed on a base sheet, and the blood separation sheet is

 (a) a zone for penetration and Z or adsorption of the blood to be separated and

(b) The permeated and Z- or adsorbed blood is subjected to a separation treatment by a chromatographic principle, and is divided into a region for retaining the separated serum or plasma, and at least the region of the above (b) is protected. It is protected by a sheet, and the test blood is permeated and Z or adsorbed in the area (a) and separated into serum or plasma. Is a specimen protection container characterized by holding serum or plasma;

 [65] Blood separation sheet power, Hemasep L (Hemasep)

: Old name—Hemadyne (available from Pall, New York, USA) Membrane or Hemasep L blood fraction

The sample protection container according to the above [63] or [64], wherein the sample protection container is: Germanman Science Japan K.K. (Note: available after the merger of Pall Corporation).

 (66) The specimen protection container according to any one of (63) to (65), wherein the specimen protection container according to the above (63) to (65), which is substantially based on the configuration shown in FIG. 1.

[67] Width (W) 1 ~! Omm, length (L) 10 ~ 200mm, and thickness 0.05 ~ 0.50mm The blood separation sheet on the substrate sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is used for the blood drop permeation of the blood separation sheet and / or Or the sample protection container according to any one of the above (63) to (6ti), wherein the sample protection container is provided so as to cover the blood separation sheet while leaving the adsorption portion.

[68] A blood separation system cut into strips with a width (\ ¥) of 2 to 5 mm, a length (L) of 30 to 70 mm, and a thickness of 0.15 to 25 mm The blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is formed of a blood separation sheet. The specimen protection described in any one of the above CG 3] to [67〗], wherein the specimen is provided so as to cover the blood separation sheet, leaving the blood dropping permeation and the Z or adsorption part. Container,

 (69) Any of the above (63) to (65), which essentially has the form shown in Fig. 2 as a basic component, the specimen protection container according to one of the above,

 [70] Blood cut into strips with a width (W) of 1 to 10 mm, a length (L) of 10 to 20 mm, and a thickness of 0.05 to 0.5 mm The separation sheet is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is formed of a blood separation sheet. One provided to cover the blood drop permeation and Z or the adsorbed portion, and the other provided so as to cover the blood separation sheet while leaving the blood drop permeation and / or the adsorbed portion. The specimen protection container according to any one of the above items 63-3 to 6 (i) and [69], wherein

 [71] Blood separation sheet cut into strips with a width (W) of 2 to 5 mm, a length (L) of 30 to 70 mm, and a thickness of 0.15 to 0.25 mm Is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is one of the blood separation sheets. The blood separation sheet is provided so as to cover the blood drop penetration and Z or the adsorbed portion, and is provided so as to cover the blood separation sheet while leaving the blood drop penetration and Z or the adsorption portion. The sample protection container according to any one of the above (63) to (66) and (69), wherein

[72] The above-mentioned [63] which is essentially based on the configuration shown in FIG. Five

The sample protection container according to any one of to

 [73] Width (W)] ~ 1 Omm, length (L) 10 ~ 20 Omm. And thickness is 0.05 ~ 0.50 mm. The separation sheet is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is Any one of the above [63] to [66] and [72], characterized in that the blood separation sheet has a window for blood permeation and blood reception at the Z or adsorption part. Described sample protection container,

 [74] A blood separation system cut into a strip with a width (W) of 2 to 5 mm, a length (L) of 30 to 70 mm, and a thickness of 0.15 to 0.25 mm. The sheet is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is one of the blood separation sheets. The specimen protection container according to any one of the above (63) to (66) and (72), which has a window for blood reception at the blood drop penetration and / or adsorption portion of the

 [75] The separation sheet protection sheet must be fixed on the base sheet where the blood separation sheet is fixed with an adhesive so that it can be repeatedly attached and peeled off. The sample protection container according to any one of (1) (6 3) to (7 4),

[76] The method according to the above [[6], wherein the blood separation sheet is sealed with a base sheet on which the blood separation sheet is fixed and a separation sheet protection sheet. 6 3) to the sample protection container according to any one of (75),

 [77] The above-mentioned [63- [76], wherein a scale is provided along the blood separation sheet on the substrate sheet where the blood separation sheet is fixed. Specimen protection container described in the description

 [78] Calibration force applied along the blood separation sheet on the substrate sheet where the blood separation sheet is fixed, as a measure for determining the amount of the component used as the specimen The specimen protection container according to any one of the above (63) to (77), which is characterized by being used.

 (79) The specimen protection container according to any one of (63) to (78), wherein a plurality of blood separation sheets are fixed on the base sheet.

(80) A plurality of blood separation sheets fixed on a substrate sheet are independent of each other. The sample protection container according to the above-mentioned item 79, characterized in that the sample protection container can be covered with a separation sheet protection sheet.

 [81] The above-mentioned [63.1 to 73], wherein a data application area of the sample management ffl is provided on the substrate sheet where the blood separation sheet is fixed. j, the sample protection container described in any one of

 [82] The sample according to any one of [81j] above, wherein a two-dimensional barcode for sample management information is provided on the base sheet on which the separation sheet is fixed. Protective container,

 [83] The base sheet on which the blood separation sheet is fixed and / or the separation sheet protection sheet is made of a transparent material so that the test sample components can be visually confirmed. The specimen protection container according to any one of the above (63) to (82), which is characterized in that:

 [84] The base sheet where the blood separation sheet is fixed, and the separation sheet protection sheet force <a self-characteristic feature of being composed of a material that can be easily cut [63] The sample protection container according to any one of to

 [85] The specimen according to any one of the above [1] to [84], wherein the separation sheet contains a liquid coagulant and, if necessary, an inhibitor. Protective container,

 [8 6] 上 記! Wherein the one-liquid coagulant is selected from the group consisting of oxalate, citrate, ethylenediaminetetraacetate, and heparin or a salt thereof. 5) Sample protection container as described,

 [87] The solid solution coagulant is selected from the group consisting of sodium citrate, sodium edetate, sodium hebalin, and heparin. ] Described sample protection container,

 [88] a sample protection container according to the above [85], which is an inhibitor, an enzyme inhibitor; and

[89] The sample protection container according to the above [88], wherein the sample protection container is an inhibitory agent \ trazirol. In another aspect, the present invention provides

 [90] Separation sheet power \

 (Λ) Two or more sheets sandwiched between the separation sheets having a width (W), which are arranged in the sample protection container in such a manner that the sides of the separation sheet are closely attached to each other. A force, or

 (B) The sheet-shaped fragment, which is made to be capable of uniformly absorbing and developing a body fluid such as blood, which is arranged in the specimen protection container. The sample protection container according to any one of the above [1] to [89],

[91] The sheet-like fragment of (B) in the above [90] is obtained by intentionally pressing a sheet obtained by cutting the large-sized sheet with a sharp force cutter and an intended cut separation sheet. The sample protection container according to the above (90 J, wherein the container is selected from the group consisting of:

 [92] The force obtained by intentionally pressing the above [91] is a force obtained by pressing the entire surface of the sheet of the sheet-like fragment, or the direction of blood development (or L The sample protection container according to the above [91], characterized by being formed by pressing a linear line in the direction

[93] The linear line of the above [92] has a single line at or near the center of the separation sheet, or a substantially uniform interval on the separation sheet, for example, a gap of 0.5 to 3 mm. In addition, two or more sample protection containers described in 2) above are provided. In the present invention, the directivity means that a serum component or a plasma component obtained from a site where a blood sample has penetrated and / or adsorbed is retained, and a local force <substantially biased in a specific direction. This means that separation based on the principle of chromatography has been achieved with a certain direction. Therefore, when a blood sample is penetrated and / or adsorbed on a directional separation sheet, it is chromatographically moved in a certain direction to cause separation, and the serum component or blood separated at a desired site is separated. Retention force <If it occurs and has such properties, it can be said that it has directivity. BRIEF DESCRIPTION OF THE FIGURES

 m1 is a plan view showing a basic configuration of the sample protection container of the present invention.

 FIG. 2 is a perspective overhead view of the sample protection container (before use) of the present invention.

 FIG. 3 is a perspective overhead view of the sample protection container of the present invention where the protection sheet is removed.

 FIG. 4 is a perspective overhead view of the sample protection container of the present invention in which blood is dropped and absorbed.

 FIG. 5 is a perspective overhead view of the sample protection container of the present invention, in which the protection sheet after serum separation is removed.

 FIG. 6 is a perspective overhead view of the sample protection container of the present invention where a protection sheet is attached for storage.

 FIG. 7 is a perspective overhead view of the sample protection container of the present invention, which is attached to a protection sheet for storage.

 FIG. 8 is a perspective overhead view of the sample protection container of the present invention, in which a plurality of blood separation sheets are attached to a protection sheet for storage.

 FIG. 9 is a perspective overhead view of the sample protection container (before use) of the present invention.

 FIG. 10 is a perspective overhead view of the sample protection container (before use) of the present invention.

 FIG. 11 is a perspective overhead view of the sample protection container of the present invention shown in FIG. 10 in which blood is dropped and absorbed.

 Fig. 12 shows the results obtained by using the serum (horizontal suspension: X) prepared by the method (centrifugal separation method) indicated by the measurement reagent used for the measurement of blood thyroxine and the sample protection container of the present invention. The correlation with the serum sample (vertical axis: y-axis) in the measurement is shown.

 Figure 13 shows the measurement of hemoglobin A and c using serum (horizontal axis: X-axis) prepared by the method (centrifugation method) indicated by the measurement reagent used and the sample protection container of the present invention. Shows the correlation in the measurement with the serum sample obtained (vertical axis: y-axis).

 FIG. 14 shows the results of the development and the turn of ^ blood obtained by dropping the blood of Example 4 into the sample protection container of the present invention having the blood separation sheet of Example 2 (A).

FIG. 15 shows the results of the development z and the turn of blood when a predetermined amount of blood was dropped on the sample protection container having the blood separation sheet of Example 2 (A) of the present invention. FIG. 16 shows the results of the unfolding of blood obtained by dropping a predetermined amount of blood into the specimen protection container of the present invention having the blood separation sheet of Example 2 (B).

 FIG. 17 shows the results of the unfolding of blood when the blood was dropped onto the sample protection container of the present invention having the blood separation sheet of Example 2 (B).

 FIG. 18 shows the results of the development of the blood of Example 2 (C) in which the blood was dropped onto the sample protection container having the blood separation sheet of the present invention having the blood separation sheet, and the results thereof.

 FIG. 19 shows the results of the development of blood when the blood was dropped onto the sample protection container having the blood separation sheet of Example 2 (C) of the present invention and the results of the measurement.

 FIG. 20 shows the results of the development of the blood when the blood of the sample S was dropped on the sample protection container having the blood separation sheet of Example 2 (D) of the present invention, and the results of the turn.

 FIG. 2I shows the results of the development and the turn of the blood obtained by dropping the blood in the specimen protection container of the present invention having the blood separation sheet of Example 2 (D).

 FIG. 22 shows the results of the development and the turn of blood when the blood was dropped onto the sample protection container of the present invention having the blood separation sheet of Example 2 (E).

 FIG. 23 shows the results of the unfolding of blood when the blood was dropped onto the sample protection container of the present invention having the blood separation sheet of Example 2 (E).

 FIG. 24 shows the result of blood development when the blood of interest is dropped onto the sample protection container having the blood separation sheet of Example 2 (F) of the present invention.

 FIG. 25 shows the results of the development and the turn of blood when a predetermined amount of blood was dropped on the sample protection container of the present invention having the blood separation sheet of Example 2 (F).

 Explanation of reference numerals

 1 Blood separation sheet

 2 Mount for fixing blood separation sheet

 3 Protection sheet

 4 Protective sheet covering blood drop site of blood separation sheet

 5 A protective system covering the separated components on the blood separation sheet

 6 Protective sheet for attaching the backing on which the blood separation sheet is fixed-7

8 Window provided in the protective sheet covering the blood separation sheet 9 Blood Droplets

 a Blood drop site on blood separation sheet

 b Site other than blood drop site in blood separation sheet Best mode for carrying out the invention

 According to the present invention, a relatively small or minute amount of a body fluid sample, particularly a serum sample, is protected so that it is not practically contaminated, and is further stably and simply and easily controlled while minimizing deterioration. Safe, less expensive means of storage, transport and transportation are shared. The use of body fluid samples, especially blood samples, which were practically impossible to date using such means for various measurements, tests, and analyzes for clinical or diagnostic purposes is now open. This makes it easier, cheaper, and safer to handle relatively small or large numbers of body fluid samples, especially blood samples. By using the sample protection container of the present invention, the space can be largely saved, and the problem of the ring i ± such as the disposal power of used instruments and the like can be reduced.

The body fluids targeted by the present invention include blood, plasma fluid, amniotic fluid, semen, exudate, leakage, interstitial fluid, cerebrospinal fluid, ventricular fluid, saliva, urine, cerebrospinal fluid, ascites, tears, etc. In particular, whole blood may be mentioned, but it is not particularly limited as long as it is a liquid component derived from a living body that can be used for test measurement. The body fluid of the present invention preferably includes whole blood. When fresh blood is left untreated, blood coagulation occurs, and then the blood cells and fibrin shrink lumps and clear supernatant is released. This supernatant is called blood. Therefore, serum is a liquid component of blood, which is generally a whole blood excluding fibrin clots and blood cells, and is not particularly limited as long as it is a simple liquid component of blood that can be suitably used for force test measurement. ,. Plasma refers to the humoral components of blood circulating in the body, and is equivalent to the portion of fresh whole blood excluding red blood cells and other components, and is usually oxalate, citrate, ethylenediamine after blood collection Add a liquid coagulant such as tetraacetic acid (EDTA) salt or heparin, or keep the temperature low to prevent the progress of blood coagulation. The force that can be obtained is not particularly limited as long as it is a liquid component of blood that can be suitably used for test measurement. W

The sample protection container of the present invention uses a constituent material that is capable of penetrating a body fluid sample for testing and measurement, preferably a blood sample, and that can separate and hold required components. A material whose form is protected so that it does not deteriorate or become contaminated. Further, the sample protection container of the present invention uses a constituent material capable of suitably adsorbing a body fluid sample for testing / measurement, particularly preferably a blood sample, and separating and holding required components. It is a form that is protected from deterioration or contamination. Adsorption is a concept that encompasses the case where a liquid is applied and the water force within it <temporarily penetrates and adheres. Is also included. The sample protection container of the present invention has (a) a region which allows a sample body fluid, for example, whole blood to penetrate and Z or adsorb, and (b) the body fluid (for example, whole blood) permeates and / or Although it may coexist with the adsorbed region, the permeation of the bodily fluid and the separation of the permeated and Z or adsorbed bodily fluid following the Z or adsorbed region by a chromatographic principle (C) coexist with a region for performing the separation process based on the chromatography principle, but may be coexisting with a region for performing the separation process based on the chromatography principle, A component having a region that allows it to be retained in a state separated from components in a body fluid (eg, whole blood) subjected to chromatographic separation (eg, whole blood). It is intended to include the things. A major feature of the sample protection container of the present invention is that the sample protection container has a structure for protecting a region in which a component in a body fluid subjected to the chromatographic separation has been retained. In the present invention, the bodily fluid can be infiltrated and Z or adsorbed, and the infiltrated bodily fluid and / or the adsorbed bodily fluid are separated by the principle of chromatographic draphy, and the components in the separated bodily fluid are separated. Can be kept in a separated state, for example, those having a »锥 structure. In particular, such a structure is a strong structure made of synthetic polymer fibers. Such a synthetic high-molecular structure is made of a synthetic polymer resin, and is preferably a melt-blown process. Examples include those that can be used to form a coherent web with a web. Examples of such synthetic polymer resins (polymers) include polyalkylene terephthalates such as polybutylene terephthalate, polyethylene terephthalate, and polypropylene terephthalate; polyalkylenes such as polymethylpentene, polypropylene, and polyethylene; Various polyimides such as hexamethylene adipamide (nylon 66), nylon 6, nylon 610, nylon 7, nylon 1 and nylon 12, and polycarbonate. Preferably, such a polymer is used after being processed into a molded article (structure) in the form of a fiber sheet (fiber mat).

 A sheet made of such a polymer fiber is modified so that its surface is grafted and the fiber sheet is well-wetted with the body fluid so that a predetermined body fluid penetrating ability and Z or adsorption ability can be obtained. Are preferred.

 The fibrous structure is particularly preferably composed of a fibrous structure capable of separating whole blood into components such as blood cells and plasma components, or blood clots and serum components by chromatography. ^; These include those that have been grafted to have the highest possible density of hydroxyl groups on the surface of the hidden structure, those that have been grafted so that hydroxyl and carboxyl groups are mixed, and those that have both hydroxyl and methyl groups. And those grafted so as to have an amine group.

 A desirable process can also be obtained by using monomers exhibiting hydroxyl groups and polymerizing these monomers in an aqueous environment. A person skilled in the art would be able to easily select which monomers to select, the strength, and the conditions for how to carry out the grafting according to the purpose.

The sheet (or fiber structure) used in the present invention is preferably, for example, a hydrophilic one made of a polyimide material. A typical example of such polyamides is nylon. Preferable nylons include polyhexamethylene adipate, polyproprolactam, polymethylene sebacamide, poly 17-aminoheptanoamide, and polyhexamethylene azeleamide. Preferred is polyhexamethylene adipamide (nylon 66) Power < More particularly preferred are noncortical, substantially alcohol-insoluble hydrophilic polyamide materials. These sheets (fibers) can also suitably have a ratio of methylene CH ₂ : amide NHC〇 in the range of about 5: 1 to about 7: 1.

The properties of this preferred type of material result, at least in part, from the concentration of amine and carboxyl end groups on the surface. The term “surface” or “material surface” refers to the external surface that is visibly exposed by using one component or a plurality of components, and a sheet composed of »fibers. An inner surface of a material existing inside is exemplified. That is, a surface is a portion of a material that can be contacted by a fluid, especially a liquid. Preferred are hydrophilic polyimide materials having controlled surface properties. Particularly preferred are hydrophilic and microporous non-cortical boriamid materials having controlled surface properties. These veined, virtually alcohol-insoluble materials with controlled surface properties include, for example, alcohol-insoluble polymer resins of the type described above, ie, a methylene CH ₂ : amide NHC◦ group ratio of about 5: 1. Can be formed by simultaneously spinning or drawing a resin in the range of from 7 to 1 with a water-soluble surface-modifying polymer having a functional polar group.

 Surface modified polymers used to make the controlled surface properties of the polyimide materials useful in the present invention include nucleophilic chemical functional groups such as hydroxyl, carboxyl, amine and imine groups. It is intended to include a substantial portion of the group. As a result, the structural material has hydroxyl groups, carboxyl groups, and amine groups on its surface that do not react with each other and contain a high concentration of functional groups, such as a combination of the above groups, or any combination thereof. It will be. These polyamides with controlled surface properties can be coated with a polyimide resin without controlled surface properties, i.e. the force formed from the preferred polyamide resin but with a surface-modified polymer. It has a higher concentration of carboxyl or amine groups than those starting polyimides that have not been modified.

Particularly useful as a sheet component of the present invention are the aforementioned methylene CHs having controlled surface properties caused by the inclusion of high concentrations of carboxyl components: Amide A hydrophilic, microporous, virtually alcohol-insoluble polyamide material formed from hexamethylene adipamide with a NHCO group ratio. Inclusion of a surface carboxyl component can be produced by simultaneously treating the niobium with a cobolimer containing a large amount of carboxyl groups.

Other materials that are particularly useful in the sheet components of the present invention are those that have a controlled surface quality and are co-moulded with the polymer containing abundant primary and secondary amine groups. The surface has been modified with amine functional groups by the treatment. A material formed from polyhexamethylene adipamide containing a hydroxyl group-modified surface thus obtained is also Arikawa in the present invention. Such materials are made by co-stretching Ny resin with a polymer containing large amounts of xyl groups. Fiber mats composed of these polymers must be capable of suitably contacting and impregnating the body fluid. For this purpose, the critical value of the surface tension (wetability-imparting surface tension critical value) that can provide the wettability of the fiber pine mat is usually about 46 dynes / cm or less. It is necessary to increase this to 65 dyne Z cm or more, preferably 95 dyne / cm or more, and more preferably 110 dyne Z cm or more. Here, the critical value of wettability-imparting surface tension can be determined by dropping a specific amount of a liquid having a specific surface tension onto the surface and measuring whether or not the surface is wet. For example, if a liquid is dropped 10 drops on the surface of the material and left as it is, the liquid is absorbed at the place where the drop was dropped, or up to 9 drops of the 10 drops. If wetting is apparently absorbed, wetting is considered to have occurred, and conversely, the liquid force at the location where it was dropped was not absorbed, or even 9 out of 10 drops were dropped. If not absorbed, the case is considered to have no wetting power. Then, if the liquid with a surface tension of 2 G dynes was dropped, the liquid quickly wetted, but if the liquid with a surface tension of 29 Dyne Z cm was dropped, no wetting occurred. In this case, the critical value of the surface tension that can impart wettability to the material (mat) (critical value of surface tension imparting wettability) is 27.5 quin / cm. . This wetting occurs The value in the case where no moisture is generated depends, of course, on the surface properties of the material constituting the constituent material and the size of the pores in the surface that interacts with the liquid. For example, in order to impregnate whole blood, it is preferable that the critical value of surface tension for imparting wettability is as high as possible. A surface tension critical value for imparting wettability of more than 65 dynes, / 'cm, more preferably more than 110 dynes Z cm. It is also a preferred product for the present invention. According to the present invention, a bodily fluid can be permeated and Z or adsorbed, and the permeated and Z or adsorbed bodily fluid is separated by a principle of chromatography, and the separated components in the bodily fluid are separated. The fiber structure that can be held is formed into a shaped body, for example, a structure such as a fiber sheet (or fiber mat). The direction of movement from the area where the body fluid penetrates and Z or adsorbed, e.g. from the area where blood penetrates and Z or adsorbed, to the place where the required components from the body fluid appear, e.g. serum, where plasma appears Is one of the factors for making an important design, which is referred to as the flow direction. The melt-blown process for making a fibrous web uses a fiber-forming nozzle with two or more passages, the innermost of which is a softened polymer resin or a molten high- The molecular resin is transported to the tip of the nozzle, while the other passages carry a high velocity of gas (usually air) to dilute the resin into fibers. Desirably, embodiments of the present invention collect fibers obtained from such a process and form a web on a moving collection surface typically located 5 to 25 cm from the nozzle tip. In order to achieve a high degree of drawing, it is preferred that the moving speed of the moving collecting surface be about 1 Om / "min or higher. When collecting at these speeds, the unity of the collected fibers will increase. Some ^ tend to be as small as, for example, about 1/10 to 1 Z 100 of the thickness required for i ^ used in the container of the present invention. Therefore, it is preferable that the structure used in the present invention requires about 100 layers of material, and when a highly stretched mat is used, serum or plasma may be used. Depending on the degree of elongation of the web with respect to the direction of flow, completely different results are obtained. The material thus obtained can be formed into a desired structure by integrating it. For example, a multi-layer structure made as described above passes the product through a laminated oven characterized by two moving belts, and the material is closed using a pressure roll in the oven; Power < This operation would combine the layers into a single, unitary sheet which could then be cut to the size desired for use in the present invention. The graphing performed to obtain the desired conditions may be before or after lamination. Lay-up can also be performed by compressing the hot plate to obtain a laminated sheet. Furthermore, a heating die may be used to make a special shape, or the pore size between the regions to be formed may be changed.

 It can also be formed into a rolled sheet shape by thermoforming in advance. For example, a multilayer fiber mat made of fibers having a diameter of 3 / m or less can be formed at room temperature, and is sufficiently usable in the present invention.

 If the body fluid undergoes separation based on the principle of chromatography ^, for example, if serum is obtained from whole blood and separated, there is no need for separation to occur so that each component in whole blood is completely separate, and the necessary puncture or analysis is required It is sufficient if the separation force can be achieved within a range that does not cause a problem. In some ^, it is desirable that the liquid component in whole blood can be substantially recovered as a serum component. Similarly, for example, in the case of obtaining plasma by separating it from whole blood, it is sufficient if the required measurement can be achieved within the range of L, which is a question for analysis.

When plasma is obtained from whole blood, it is usually used as a coagulant such as citrate, oxalate, ethylenediaminetetraacetate, heparin or a salt thereof (for example, sodium citrate, sodium edetate (EDTA-2N a), heparin sodium, heparin, etc.) and, if necessary, a container containing an inhibitor such as trazinol or the like. Put it in a container containing a blood coagulant or an inhibitor, mix it well, and then subject it to a separation process based on the above-described chromatographic principle. As another method, an inhibitor such as the above-mentioned liquid coagulant and, if necessary, an enzyme inhibitor should be present in advance at the site where the collected fresh blood can penetrate and Z or adsorb, and such a region can be used. To The purpose can be achieved by directly applying the collected fresh blood and then achieving separation. In the present invention, the structure used to hold the body fluid sample has a property of a directional separation sheet. It is preferably and conveniently used. Particularly preferred directional separation sheets (some may also be referred to as directional separation mats) are those that convert whole blood into clots and serum components, such as blood cell components, or blood components and plasma components. It has properties that can be separated by one principle of chromatography. In such a directional separation sheet, a barrier layer is provided in an area where the separation occurs to allow the movement of serum components or plasma components, but components which should be excluded from serum components such as blood clots or the like. It is also possible to provide a layer (layer で き る) that can substantially prevent the passage of components that should be removed from plasma components such as red blood cells. The layer may be a porous layer, more preferably a microporous membrane. Examples of such a microporous membrane include those made of boriamid such as nylon 6, nylon 66, and nylon 61. The surface of the microporous membrane is preferably a hydrophilic resin membrane, such as a pulsed fluorocarbon resin membrane. Further, the directional separation sheet may be provided with a structure having a strong capillary suction force suitable for holding serum or plasma. Examples of such a structure include the above-described microporous membrane. As a structure used to hold such a body fluid sample, for example, the structure disclosed in Japanese Patent Application Laid-Open No. 5-318202 is cited. Also preferably, Hemasep L) (trade name: former name—Hemadyne); 25 Harbor Park Drive Port Washington, NY, USA ). Pall (Pal BioSupport Division available manually) Membrane or Hemasep L blood fraction ίΙ [Product name: German Science Japan K.K. : Available from Nippon Pall Co., Ltd.).

When a directional separation sheet is used in the sample protection container of the present invention, its size is adjusted to an appropriate size as described in detail below. From a sheet of a smaller size (e.g., cut by sawing, etc. For example, in the case of £, these are cut to a certain size by mechanical cutting using a cutting machine, etc.) In this case, a large pressure is applied to the cut surface, and the obtained sheet-like fragments are problematic in absorbing and expanding blood and the like ^ That is, the cut surface and its vicinity are shrunk (or crimped) when the large-sized sheet is cut into sheet-like pieces, and as a result, the sheet is formed. When the blood absorbs and expands, such as when the microscopic structure such as the fiber structure becomes non-uniform and the blood is absorbed and expanded, the serum (in the vicinity of the cut surface and its vicinity) where the compression (or pressure そ う し た) has been applied causes the serum to flow quickly. Unfold and move the other sheet parts and their unfolding (A There will be different with respect to movement). If the force and thus the uniform absorption and development cannot be achieved, there is a problem in that when sampling is performed, the amount of sample such as serum per unit area of the sheet becomes uneven.

 In order to avoid such a problem, when the separation sheet is placed in the sample protection container, two or more sheets having a narrow width (W) of the separation sheet are used. It is preferable to place the side-by-side pieces in close contact with each other, or as a net-like piece that is made to absorb and expand blood and the like uniformly.

 The present invention also relates to such an improved sample protection container.

 When a plurality of sheets having a narrow width are arranged side by side, a separation sheet having a substantially uniform width (W) is preferably used, but the separation sheet is not necessarily limited to this and may be used for the intended purpose. It can be selected and used according to.

Examples of the sheet-like fragments that are capable of uniformly absorbing and developing the blood and the like include, for example, a sheet obtained by cutting the large-sized sheet with a sharp cutter (cutting with a sharp cutter). Therefore, it is considered that a large pressure is applied to the cut surface to avoid the force.) Or, a target cut sheet that has been intentionally pressed is used. Any material that can absorb and expand blood and the like uniformly without limitation is acceptable. Here, “to uniformly absorb and develop blood and the like” means that when sampling a sample, for example, the amount of sample such as serum per sheet unit area is large, Means that there is no substantial difference, and Z means that there is substantially no adverse effect on the intended measurement / inspection results. Serum and the like spread and move quickly only at and near the cut surface of the separation sheet, but are absorbed and developed near the center of the separation sheet, so that there is no possibility that it will be lost. Good. When the press is intentionally performed, for example, the entire surface of the sheet of the sheet-shaped fragment may be pressed, or a linear line may be pressed in the blood developing direction (or L direction). May be. The linear line may be processed in a single line at or near the center of the separation sheet, or two or more lines may be formed at substantially equal intervals, for example, at intervals of 0.5 to 3 strokes. Providing a plurality of the above can be powerful.

 The press working is not particularly limited as long as the intended purpose can be attained. For example, the force obtained by a method known in the art <the force that can be performed < More suitable: M It can be used by setting appropriate conditions. The pressing can be performed, for example, by pressing with a pressure of 20 to 200 kgs / cm-, and more preferably, by pressing with a pressure of 40 to 100 kgs / cm-. Can be done. Typically, in the case of a linear line, the line is formed by pressing the sheet under a pressure of 40 to 100 kgs / cm- '. Thus, the present invention provides a specimen protection container characterized in that the directional separation sheet for blood is protected.

 In the present invention, when protecting a structure holding a sample, the structure, form, or shape may be such that the sample is stably held. In such protection, it is preferable to adopt a structure in which the region holding the specimen in the above structure is not contaminated, for example, such that the region force <substantially does not generate an exposed portion. Form.

Factors that destabilize the specimen include oxidation by air in the atmosphere, degradation by light, denaturation of proteins and other components by, degradation by oxygen and the like contained in the specimen, contamination and decomposition by bacteria, etc. Deterioration due to the reaction between components, evaporative concentration, etc., occur, and as a result, power is generated if denaturation occurs. I can do it. Any structure or means that substantially eliminates or eliminates these factors can be used without limitation as long as they meet the purpose of the present invention and are acceptable. . In the present invention, a structure or means known in the art that contributes to eliminating the above-mentioned factors that destabilize the sample, and a structure (for example, Masseb L (Hern asep L) [trade name: available from Paul (Pal 1), New York, USA]; Hemasep L blood separation key [trade name: Germanic Science Japan Co., Ltd. (Note: Nippon Pall Co., Ltd.) Can be used manually as long as it can be recognized as a structure or form or shape that can be used in conjunction with)).

Such protection of the specimen can be achieved by coating it or by casing it. For example, a structure achieved by coating a structure holding a specimen in a sandwich type with a sheet may be mentioned. In such a case, it is preferable that a part of the skin cover sheet is provided so that the sample can be easily collected at the time of test and measurement of the sample, and it is preferable that the entire cover sheet can be easily attached and detached. As a means to secure the attachment and detachment of such a covering sheet, a tight interface force <formed between the same or different types of objects, and the phenomenon that the strength that can transmit the applied stress through the interface in a purposeful manner appears. Examples of the method include a method using an adhesive, for example, a method using adhesion. Such adhesion mechanisms include, for example, those described in Takao Saito, Industrial Materials, Vol. 4 No. 4, pp. 78-88, 1989, The contents thereof are included in the contents of the present specification as a reference in the present specification, and any of L and shift mechanisms among these bonding mechanisms can be arbitrarily selected and used in the present invention. is there. For example, those which exhibit an optimally controlled attractive interaction by realizing close interfacial contact, and which respond viscoelastically by the system being piled up to a load can be used in the present invention. In order to achieve close interfacial contact, the adherend (object to be adhered) is connected by some kind of connection (through an adhesive between the dents and narrow gaps on the adherend surface, including ii ^). Is formed by forming a polymer, for example, under conditions in which compatible molecules can exert their molecular mobilities sufficiently. When they are made to contact each other due to their mutual diffusion, or when the adherend is located, the adhesive on the surface of the adherend, the coating agent, etc. <forces are very close to each other, and the atom Attraction interaction force between molecules, etc. A state that has been significantly generated, such as a force generated by adsorption. Preferably, the means for securing the attachment / detachment of the bonded sheet includes a method utilizing the adhesion achieved by the coating agent and the chemical adsorption at the interface. Structural strength adopted in the space. Preferably, the adhesive surface provided with the coating agent and / or the adhesive is at least partly or capable of being repeatedly applied and removed. Adhesives are those that can be bonded simply by pressing with the pressure of about a finger pressure. <For example, they are evenly applied to paper, plastic film, foam, metal foil, cloth, etc., and are commercially available as so-called adhesive tapes and sheet labels. Some of those used are listed. Depending on the base polymer used, adhesives include rubbers, acrylics, silicones, and polyvinyl ethers.The adhesives can be used at night, suspension, hot melt, and solid. Glue type ones can be mentioned. Examples of the polymer material used for the adhesive include natural rubber such as polysoprene, styrene-butadiene rubber, butyl rubber, polyisobutylene rubber, polybutyl acrylate, 2-ethylhexyl polyacrylate, polyacrylic acid, and silicone rubber. Styrene-isoprene-styrene block polymer, styrene-butadiene-styrene block copolymer, styrene-ethylene-butylene-styrene block polymer, and the like. Adhesives include, if necessary, tackifying resins such as rosin-based, coumarone-indene-based, terbene-based, petroleum-based, styrene-based, phenol-based, and kylene-based; softeners, such as polybutene and polyisobutylene , Polyisoprene, process oil, naphthenic oil, etc .; fillers, such as titanium white, zinc white, calcium carbonate, clay, talc, pigments, carbon, etc .; anti-aging agents, such as phenolic, amine based, etc. Crosslinking agents, for example, those based on thiram, phenol and isocyanate can be added. The base material on which the adhesive is applied is paper (cellulose), cellulose nitrate, cellulose acetate, cellulose acetate butyrate, cellulose propionate, cellulose cellulose such as ethyl cellulose, polypropylene, polyvinyl chloride, polyethylene, etc. Materials such as polyester such as terephthalate, polyimide, 4-fluoroethylene, epoxy resin, etc., gold laminates such as aluminum laminates, metal lumines such as aluminum lan, cloth (for example, Fabrics, knits, etc.), non-woven fabrics, foams (eg, polyethylene, polyurethane, polystyrene, vinyl chloride, natural rubber, black-mouthed plain, etc.).

 The paper used for the base material can be selected from Western paper, Japanese paper, and paperboard, and furthermore, chemical fiber paper can be used.

 Examples of the release agent used when a release agent layer is provided on a coated sheet include silicone rubber, stearyl methacrylate.acrylonitrile copolymer, and chromium complex, which are known in the adhesive-related technical field. You can select and use force from among them. For such adhesives, reference can be made, for example, to the Japan Adhesive Tape Manufacturers Association, Adhesive Tape Handbook, 1998, or references cited therein. In this document, it is included in the contents of this specification by reference. The sample protection container of the present invention is preferably in the form of a body fluid separation sheet, particularly a blood separation sheet, and more preferably in the form or shape of a sheet or film. Can be

Since the sample protection container of the present invention can be configured in a paper or sheet shape, it is possible to effectively use the margin of the paper or sheet shape container, for example, to provide a data management area for sample management. It can also be provided. By providing the sample management data there, test samples are automatically managed, and rapid and safe sample processing becomes possible. When an examination is requested, the “Inspection Request Form” usually contains basic information such as the subject's name, age, and gender, as well as necessary information such as examination request items and medical institution items such as chart numbers. When handling the application, make sure that the symbols (such as identification numbers) in this request form match the symbols affixed to the sample. The business and the request information management (mainly by computer) are managed separately, and they are handled based on 1 ¾ another symbol. In addition, in the test result report, information is integrated into the report so that it can be managed by medical institutions. As a general information management form in such a case, an identification symbol, a barcode, or a two-dimensional barcode that can directly describe information is used.

 In the sample protection container of the present invention, such management information as a code I, a bar code, and a two-dimensional bar code in which information can be directly written is stored together with the sample, stored, moved, or transported. In addition, the ability to manage large quantities and accurate specimens enables the use of more accurate laboratory tests. In particular, the use of a label with patient (specimen) information attached to one side of the container (eg, information using a specimen code and a unique code) makes it easier to carry out burial. In the field of clinical testing, barcodes are used to make it possible to partially control patient sample collection sites, such as individual management at each date and time. \ In addition, centralized management of specimens by computer, clinical testing equipment There is a growing need to improve the analysis efficiency by automatically identifying the samples to be analyzed in sample and sample transport systems, to control test accuracy, and to automate clinical tests. In the field of clinical examination, management of solid 固体 ^ and unique information is required more accurately than item identification. In addition, the integration of objects (samples) and information (inspection results) using a high information volume and high-density barcode that can contribute to the promotion of information-related business related to medical care and the advancement of medical device intelligence is autonomous distributed It is also required in the construction of an information management system that is oriented toward information technology. In this way, the integration of objects and information in consideration of the validity of the code allows the immediateness of processing, autonomous decentralized processing, and single-piece S ^ ij accuracy to be achieved. The need for high-density hiding and 'densification' is needed. The sample protection container of the present invention is suitable for utilizing such a barcode symbol with high joy and high density.

In the case of a sample label applied to a conventional blood collection test tube, errors due to the curved surface of the test tube wall and further contamination (for example, contamination of the label with blood or chemicals, contamination of the label with writing utensils, etc.). Restoration (security level) Due to the problem of ensuring the performance, the bar code symbol has a high level of affection and the density is limited. <The sample protection container of the present invention has a paper or sheet shape. Can be configured as It is suitable for attaching high-density, high-pass, two-dimensional, one-code, etc. one-code symbols. According to the present invention, there is provided a specimen protection container characterized in that a data providing area for specimen management is provided on a base sheet on which a separation sheet is fixed. Provide a container. In particular, in the present invention, the sample protection container is characterized in that, for example, a high-density and high-energy barcode symbol such as a two-dimensional barcode is provided in a sample management data provision area. Is done.

 The one-dimensional barcode is an application of a one-dimensional visual system composed of a stripe pattern formed by a combination of bars and spaces of different widths. Barcode symbols represented by 7 etc. 2D-codes are dimensional matrix or stacked barcodes and symbol codes, such as Codel6K, Code 49, PDF417, Codablock, Vercode. , Data Code, UPS Code and so on.

 The Iff density and the † t¾ capacity are determined by the application of the object to be applied and the attached area of the barcode attached object, but with the sample protection container of the present invention, the barcode attached area has a large degree of freedom. It is possible to provide. Therefore, it is understood that the sample protection container of the present invention has excellent characteristics for attaching a two-dimensional node. The use of a two-dimensional node <code> makes it possible to manage specimens with high density and high passion. For example, it is possible to attach test request information and test result information. By attaching the test request information to the container holding the sample, the sample and the information can be integrated and managed. It is also possible to directly control and record the previous value as information of the dilution factor in a separate column. It is also possible to ensure data integrity and assurance.

The specimen protection container of the present invention, which is provided with the data management area for specimen management, and in particular, the specimen protection container of the present invention which is attached with information by a bar code or the like. It is suitable for constructing a sample transport system, and is used in a system that automatically transports samples to an automatic sorting device, and has the potential to greatly contribute to labor saving, labor saving, and speeding up. ing. Also applied to clinical test automation systems Suitable for The use of barcodes in the field of clinical testing, as well as clinical tests and clinical test automation systems that utilize a sample transport system ^ For example, see Yoshiki Tani, Barcode, pages 35 to 3 9 and April 1993; Medical and Computer, Vol. 6 _N No. 4, pp. 2 (298)-pp. 8 (304) and pp. 38 (34) To page 62 (357), July 1994, etc., which are incorporated herein by reference. . One specific example of the blood sample protection container of the present invention is shown in FIG. In FIG. 1, blood separation sheet 1 is Hemasep L (trade name: obtained from Pal 1 of New York, USA). The membrane has a width (W) of 2 to 5 mm. The length (L) is 30-7 Omm, and the thickness is 0.15-0.25 mm. The blood separation sheet 1 is, if necessary, of width (W) 1-10 mm and length (L) 10-200 mm, and thickness of 0.05-0.50 mm. Ability to select an arbitrary size Even if the size is other than this, those skilled in the art can freely select and design as appropriate in consideration of the purpose and efficiency. The thickness of the strip-shaped membrane is fixed! f ^ By selecting a specific width (W) of the membrane, the amount of sample required for measurement can be easily determined by using the length of the test sample component holding portion of the membrane as a measure. The concentration of the analyte in the sample used for analysis can be easily adjusted).

 The blood separation sheet 1 is fixed on a separation sheet fixing mount (separation sheet fixing sheet) 2 using an adhesive (adhesive). If the adhesive (adhesive) does not adversely affect the specimen, it can be selected from known adhesives and adhesives. The separation sheet fixing board is a typical example of a base sheet. When adhering or sticking on the separation sheet fixing board 2, it can be adhered or adhered so as not to move as a whole, or can be fixed so that only a part thereof is adhered or adhered.

Examples of adhesives include the Japan Adhesive Tape Manufacturers Association, Adhesive Tape Handbook, 1985: Kaoru Kimura, Adhesion Handbook, Polymer Publishing Association, 1985; Masaki Shinbo, Nishino, N Book, 2nd edition, Nikkan Kogyo Shimbun, 1980; Takamon Kamon and Katsuyoshi Saito, Adhesion Handbook, 12th edition, Polymer Society, 1980, etc., or What is described in the literature cited in them <power. The blood separation sheet fixing board 2 is not particularly limited as long as the blood separation sheet i is of a size that can completely fit as shown in FIG. 1, for example, a width of 5 to 3 O mm and a length of It can be 35 to 40 O mm. When fixing a plurality of blood separation sheets I, the size is not limited to the above size, but is preferably B5 size (182 x 2557 mm) and Λ4 size of Japanese Industrial Standard. (2 10>: 2 Π 7 mm), B4 size (2 5 7 x 3 G 4 mm), Λ 5 size (1 48 x 2 i 0 mm) L, R is a standard size, and it is also preferred. The thickness of the backing sheet is not particularly limited as long as it is LJI as ordinary paper, and it can be selected and used. A scale can be provided on the fixing board 2 where the blood separation sheet is fixed, along the blood separation sheet. By providing the scale in this way, the amount of the component to be used as the specimen can be easily determined using the scale as a scale. For example, a strip-shaped blood separation sheet with a size of 2 mm x 60 mm that absorbs 201 blood ^ (especially Hemasep L) (trade name: Pol, NY, USA) (Obtained from (Pal 1)) The area of the separated serum component is, for example, 2 mm xl 1 mm = 22 mm-and a strip of 3 mm x 60 mm * lill When a liquid separation sheet is used, the area of the separated serum component is 3 mm x 7 mm = 21 mm-, and when a strip-shaped blood separation sheet with a size of 5 mm x 60 mm is used, Even if the size of the blood separation sheet changes, the area of the serum component obtained by the separation process is almost the same, as the area of the separated serum component is 5 mm x 4 mm-20 mnr. Since it shows a constant area, it is possible to quantitatively collect a test sample using the area of the separation sheet as an index. In other words, by cutting out a specific area and using it for inspection, a fixed amount of sample can be always obtained, and dilution with a buffer or the like is not particularly necessary. A plurality of blood separation sheets can be fixed on the blood separation sheet fixing mount so that multiple samples can be stored and transported. In addition, the plurality of blood separation sheets fixed on the blood separation sheet fixing board can be covered and protected with a protection sheet for separation sheet independently of each other. Can also be. When a plurality of such blood separation sheets are fixed, a perforation 7 can be provided on the blood separation sheet fixing base so that each blood separation sheet unit can be separated. (See Figure 9). Further, a data application area for specimen management can be provided on the blood separation sheet fixing mount. By assigning the data for sample management to the sample in this way, the test sample is automatically managed, and rapid and safe sample processing becomes possible. In addition, the ability to manage a large number of specimens accurately can be obtained, so that more accurate clinical tests can be obtained.

As the mounting sheet for fixing the separation sheet used in the present invention, (1) a material to which an adhesive can be applied for fixing the separation sheet, (2) a film-like material having a uniform thickness, and (3) a light shielding property is particularly required. If not, a transparent (translucent) material (a material that has transparency (translucency) even when colored), (4) a material with high gas and liquid blocking performance, and (5) excellent temperature resistance (Freezing to 50 ° C), (6) easily cut material, (7) writable material with general writing utensils, (8) material that can be incinerated as combustible material (9) adhesives that are not modified by the adhesive, and (10) adhesives that do not easily penetrate into the adhesive; . Separation sheet fixing mounts that more satisfy the above-mentioned performances are more preferable, but their performance depends on the type of sample to be treated and the purpose of the measurement 'for the purpose of analysis'. It is permissible to take into account as appropriate to satisfy only Examples of the mounting sheet for fixing the separation sheet include those made of a material selected from base materials to which the pressure-sensitive adhesive is applied. The blood separation sheet 1 set on the separation sheet fixing mount 2 is further covered with a separation sheet protection paper (protection sheet) 3. The separation sheet protection paper 3 is usually provided so as to cover the portion b of the blood separation sheet 1 except for the blood dropping portion a of the blood separation sheet 1. Blood dropping of blood separation sheet 1 The part a is easily separated with a separation sheet protective paper (protective sheet) .1 so that the liquid separating sheet 1 is not contaminated until the sample protective container of the present invention is used. It can be set up so that it can be removed.

 In another structure, the protective sheet 3 and the protective sheet 4 are forcibly integrated into one sheet to form a separated sheet protective paper (for example, FIG. 10 and FIG. 11). Thus, the blood separation sheet 1 set on the separation sheet fixing mount 2 may be in a protected form. Preferably, in such a structure, a window 8 opened in the protective sheet 3 is provided at the blood dropping portion a of the blood separation sheet 1 (for example, FIGS. 10 and 1). 1) Power < The shape of the window 8 may be any shape as long as it can penetrate and Z or adsorb blood into the lower part a of the blood droplet, for example, any shape such as an oval, a square, or a cross is possible. It is. The separation sheet fixing board 2 can be arbitrarily color-coded so that the [III droplet lower part a] and the other part of the blood separation sheet 1 can be visually checked. Further, the separation sheet fixing board 2 is provided so that the sample component for the test sample separated and processed can be easily collected as described below. Any of the areas can be color-coded (so that they can be easily identified).

 Another method is to put the separation sheet mounting sheet 2 in a container such as a sealable bag of an appropriate size, seal it if necessary, use it for storage and / or transportation, and use it. Sometimes this can be achieved by taking it out. Under the blood dropping part a of the blood separation sheet 1, that is, between the blood separation sheet 1 and the separation sheet mount 2, a blood absorbing portion is provided so as to absorb excess blood among the dropped blood. A filter paper can be provided to prevent extra blood from leaking out, and it is possible to always separate blood clots and serum components on a blood separation sheet under uniform conditions. There are advantages.

When plasma components are obtained separately, 、 1 liquid coagulant such as citrate, oxalate, ethylenediaminetetraacetate, heparin or a salt thereof (for example, sodium citrate, sodium edetate) (EDTA-2 N a), heparin sodium, to ), And an inhibitor such as trazinol, if necessary, can be present in the blood separation sheet 1 in advance. In this case, fresh blood can be directly applied to the blood dropping portion a to permeate and Z or adsorb it. Inhibitors such as the liquid coagulant and, if necessary, an enzyme inhibitor can be present throughout the blood separation sheet 1 or locally in the blood dropping portion a. However, whether to adopt the deviation can be appropriately selected and performed according to the purpose. By using a blood separation sheet that has been impregnated with a liquid coagulant or coated in advance, blood can be subjected to separation processing in a relatively new ^! . For example, it is possible to reduce the effects of hemolysis. When using the blood sample protection container of the present invention, first, if there is a protective paper 4 in the portion a where the blood is dropped, remove it (see FIGS. 2 and 3). Next, at the fingertip, 1 to 1 drop of blood obtained by lancet puncture from the earlobe (earlobe) is dropped on the blood drop portion a (see Fig. 4). As in the specific example shown in FIG. 10, a window 8 is formed at the protective sheet 3 (which entirely covers the blood separation sheet I) above the part a where blood is dropped. If it is open, drip blood onto its window 8 without removing the protective sheet 3 (see Fig. 11).

When using finger blood or ear blood as a test sample, a more specific method of collecting blood is to massage or warm the fingertip or ear of the subject well before puncturing, and then puncture with disinfecting gauze. It is preferable to use a method in which the site is wiped dry, and a blood is obtained by puncturing a fingertip or ear で with a disposable lancet or a scalpel. In this case, it is preferable that the wound is as small as possible (about 3 mm or less). The first blood drop is wiped off, and the next blood drop is adsorbed on the blood dropping portion a of the sample protection container of the present invention. Normally, the blood separation sheet I is kept dry until the sample is adsorbed. Normally applied blood is about 20 to 30 u1. In performing this dropping, it is preferable to drop the blood so that the blood permeates the entire blood dropping portion a of the blood separation sheet. This can also be suitably adjusted by arranging an extra piece of filter paper for absorbing blood below the drip portion a. And this is the blood The width (W) of the release sheet can also be controlled by appropriately selecting the width (W), preferably the width (W) can be 2 to 5 mm, more preferably 2 to 4 mm. You. After the dropping of blood, in this figure (eg, Fig. 4), the blood is opened in the right direction, and serum is separated in the area covered with the protective paper 3. For example, when blood is dropped on the entire drip portion a, a purified portion with a length of about 1 () to 15 mm can be obtained on the serum separation sheet. Separation into serum can usually be performed for 2 to 5 minutes

After the serum separation process is completed, the protective paper 3 is removed and the blood separation sheet 1 is dried in a normal process (see Fig. 5). The separated blood sample is preferably air-dried (air-dried). After sufficiently air-drying, the blood separation sheet 1 that holds the blood in the sample protection container should be stored in a refrigerator (2 to 8 ° C) while avoiding moisture absorption. Therefore, a protective sheet 5 for storage and Z or transportation is attached on the mount 2 on which the dried blood separation sheet 1 is fixed (see FIG. 6). The separated serum part can be placed on L, ^, which keeps the serum part moist, without removing the protective paper 3 or, if the protective paper 3 is removed, the serum part will not dry out A protective sheet 5 can be stuck on it. As another method, after mounting the fixed backing sheet 2 of the blood separation sheet 1 in a container such as a sealable bag, the mouth of the bag may be sealed. In addition, the protective paper 3 is covered, and the backing 2 on which the separation sheet 1 is fixed can be attached to the protective sheet 6 for storage and / or transportation (see FIGS. 7 and 8).

The protective material (sheet) for the separation sheet (eg, protective papers 3, 5, and 6) used in the present invention has the following properties, namely, from the adhesive for fixing the release sheet to the following. Material, ② film-like material with uniform thickness, ③ material with high gas and liquid blocking performance, 素材 material with excellent temperature resistance (freezing to 50 ° C), ⑤ material that can be cut easily [6] Among materials that can be incinerated as combustibles, those having at least one or more of them are preferable. Protective materials for separation sheets that more satisfy the above performance are more preferable, but their performance depends on the type of sample, the type of measurement and analysis, the purpose, etc. To satisfy only some of them It is permissible to consider it as appropriate. Examples of the protective material for the separation sheet include those made of a material selected from the base materials to which the pressure-sensitive adhesive is applied.

 When the protective sheet 5 or 6 is adhered onto the separation sheet fixing backing 2, an adhesive may be applied to the backing 2 in advance so that it can be easily adhered. Alternatively, an adhesive may be applied to the protective sheet 5 or 6 side. The pressure-sensitive adhesive layer provided in this manner is a material that can be repeatedly adhered and peeled <preferable, and before use, the release paper is peeled off to expose the pressure-sensitive adhesive layer and be used for adhesion. You may be doing it. Also, the adhesive layer may be provided so that the separation sheet 1 is tightly dimensioned by the backing 2 to which it is fixed and the protection sheet 5 or 6 (and further by the protection sheet 3). Good. It is also possible to use a metal laminate sheet as a cover sheet or to use the metal laminate sheet as a storage bag in order to further ensure the sealing performance. Preferably, a material that can secure sufficient sealing properties via the pressure-sensitive adhesive layer is used, which is preferable in terms of easiness. It is more preferable that the adhesive does not denature the separation sheet fixing sheet and the separation sheet, and / or does not penetrate the separation sheet fixing sheet and the separation sheet. Those having one of these properties are preferable, but adhesives that satisfy the above-mentioned properties more are more preferable.However, those properties depend on the type of sheet to be treated and the like. If so, it is arbitrarily possible to consider only some of them to be satisfied. Instead of adhesives, coatings that use the same properties or adsorption phenomena in the coating layer can also be used. Their performance depends on the type of sheet, etc. to be handled, and those skilled in the art can arbitrarily use only a part of them. The specimen protection container thus stored and / or transported can be handled as follows when conducting the test.

The serum part on the separation sheet is cut out with scissors together with the separation sheet. In particular, select and cut out the required parts used for inspection. For example, since the serum portion exists on the separation sheet with a length of about 10 to 15 mm, the serum portion of the separation sheet must be of an appropriate length (to obtain the test components required for measurement). L '), and the cut serum part The protective sheet (5 or 6) for preservation is removed from the separation sheet, and the test component held in the separation sheet as a solid phase is extracted into the liquid phase. · Focus on analysis. The protective sheet (5 or 6) can be peeled off before cutting the separation sheet with scissors. In addition, a separation sheet portion in which a component desired to be used as a sample is located can be arbitrarily selected and cut and used.

 As long as it is possible to perform substantially native extraction of the test component retained in the separation sheet into the liquid phase, no extraction solvent is used for this extraction, and the extraction method Is not particularly limited. From the viewpoint of performing extraction as natively as possible, it is preferable to use a buffer solution (pHG.8 to 7.G) such as a lys buffer solution or a phosphate buffer solution as the extraction solvent.

 From the viewpoint of extraction efficiency, the extraction solvent preferably contains a surfactant (preferably, a nonionic surfactant such as Tween-20). The concentration of this surfactant is preferably about 0.1 to 0.5% J.

 The extraction conditions are not particularly limited. For example, when a test component is held on a spot filter paper having a diameter of 3 mm (thickness: about 1 mm), the following conditions are preferably used. Extraction solvent: Tris buffer containing 0.1 to 0.4% Tween 20 (0.05 to 0.2 mol / L) or phosphate buffered saline

 Extraction solvent volume: 200-300〃 L

 Extraction temperature: normal temperature (about 25 ° C)

 Extraction time: 〖~ 4 hours

 The above explanation is mainly for the case where serum is obtained. The force <described above, when plasma is used instead of serum, or when a plasma sample is obtained, the same processing can be used for testing. The specimen can be obtained and transported and stored.

The method of the measurement is not particularly limited as long as various measurements in the above-mentioned extract can be performed. The measurement of the analyte includes, for example, high performance liquid chromatography, electrophoresis, ultracentrifugation, colorimetry, precipitation, atomic absorption spectrometry, chemiluminescence, gas chromatography and the like. For example, as many as 41 types of amino acids and diamino acids are 0-phthalaldehyde (0 PTA), including 0-phthalaldehyde ZN-acetyl-L-cysteine (ΟΡΤΛΖΑcCys). Use of liquid The measurement can be performed efficiently by chromatography and fluorescence analysis. Further, a method utilizing a reaction having specificity such as an enzyme reaction or a ίίΐΐ ^ antibody reaction can be used. Biochemical tests using enzymatic reactions include, but are not limited to, lyse, amylase, lysozyme, acid phosphatase, aldolase, and serum alanine aminotransferase (ALT [Glutamic acid pyruvate transaminase: GPT )), Serum aspartate aminotransferase (AST [glutamate oxaloacetate transamine; GO-cho]), cholinesterase (ChE), creatine kinase (CK), adenosine deamine, lactate dehydration ^ Hydroxybutyrate dehydrogenase (α-HBD), α-glutamine transpeptidase (α-GTP), leucine aminopeptidase (LAP), etc. In some cases, a specific synthetic substrate or a naturally occurring substrate is used to Or contact measurement, it is often a useful reference to coupling enzyme.

 Methods using specific binding, for example, methods using complementary nucleic acid sequences, effectors and receptors, enzymes and inhibitors, receptors and ligands, complement binding reactions, reactions between antibodies and antigens, etc. Can also be used.

 Methods using the above complementary nucleic acid sequence include polymerase 'chain' reaction (PCR), reverse 'transcriptase' polymerase 'chain reaction (RT-PCR), insitu hybridization, and the like. One-way, southern-blot, and hybridization.

(1) The ability to preferably use an immunological assay utilizing an antibody reaction. Examples of the above immunoassays include the Western blot method, the Octaloni method, the nephrometry method, the immunoelectrophoresis method, the latex agglutination immunoassay, the hemagglutination reaction, the radioimmunoassay (RIA), and the S-Hologen immunoassay. Method (EI Α), fluorescent immunoassay method I Α) equivalent strength <available. In some cases, it is preferable to use a fluorescence immunoassay, particularly a time-resolved fluorescence immunoassay (TR-FIII), because of its high sensitivity <easy to obtain. Test samples processed using the sample protection container of the present invention, such as serum and plasma, can be subjected to various tests. Endocrinological tests (including tumor-related tests) such as function tests, thyroid function tests, kidney and gastrointestinal function tests, adrenal medulla and adrenal cortex function tests, gonad function tests, placental function tests, and parathyroid-related tests , Immune component determination test, serum protein related speed test, blood glucose control indicator test, enzyme fractionation-related test, serum protein component qualitative / quantitative test, etc., test for plasma protein abnormalities, antibody test, antigen test, hepatitis virus test, Immunoserologic tests such as infectious disease serologic tests, autoimmune serological tests, etc., immunohematological tests, platelet function tests, general coagulation tests, coagulation factor tests, coagulation and fibrinolytic tests (Including blood coagulation test), protein test, colloid reaction test, vital pigment test, porphyrin-related test, glucose metabolism test, lipid test, nitrogen-containing component test, clearance test Biochemical tests such as electrolyte tests, metal tests, enzyme activity tests, vitamins and other tests (including tests related to industrial medicine such as lead and organic solvents), drugs for the central nervous system, drugs for the cardiovascular system, antibiotics, narcotics , Toxicological drug analysis, congenital abnormal chromosomes, blood disease chromosomes, immune-related genes, leukocyte Z malignant lymphoma-related genes, cancer genes, genetic diseases, etc., HLA tests, transplant-related tests, etc. Testing · HLA and cellular immunoassays. For these tests and measurements, if necessary, for example, edited by Hisashi Tanaka and Setsuo Takayama, Pharmaceutical Development, Vol. 10, Diagnostics, Hirokawa Shoten, Published March 15, 1990; SRL, Inc. Guidance 19995, prepared in April, 1993, GO, 000 The various tests listed in ΦΝE can be listed, and the contents and the references cited therein are self-published. The contents of the present specification are incorporated herein by reference.

Example

 Next, the present invention will be described with reference to examples, but the present invention is not limited thereto. The present invention is based on the concepts set forth in the description and the claims, without departing from the scope of the invention, and is understood to be within the $ 5 range of the present invention. Should be. Example II

 As a disposable lancet for fingertip (or earlobe) blood collection, a commercially available penlet Ii (trade name, sold by Tanabe Seiyaku Co., Ltd.) was used.

 1. Blood sampling method

 When collecting blood from your fingertips, first wash your hands with stone 鹼 and water (using hot water improves blood circulation and make it easier to collect blood). Then, hang your arm around your body for 10 to 15 seconds. Then, squeeze the fingertip to collect blood and disinfect the area to be punctured with cotton swabs. Make sure that the disinfected fingertips are dry, and then, with the cap on, securely attach the pen pallet II with the two-pro lancet to the finger. Penlet I Press the button on the I and stab your fingertip, and squeeze your finger for a few seconds until enough blood drops are obtained. The site where blood is collected should be different each time. Avoid doing so with no change, as it may make you feel throbbing or firm your skin.

 Before collecting blood from the ears, the examiner's ears should be warmed or warmed well before puncturing, and the punctured area should be wiped dry using a disinfecting case, and the ears should be removed using the disposable lancet or scalpel. Was punctured to obtain ear 朵 blood. The first blood drop is wiped off, and the next blood drop is absorbed by the site a of the separation sheet in the sample protection container of the present invention shown in FIG. After air-drying sufficiently, they were stored in a refrigerator (-1 ° C) to avoid moisture absorption.

2. Extraction conditions

A part of the area b of the separation sheet 1 for separating and retaining the ear blood obtained as described above into serum is punched out with a 3 mm diameter punch or a sheet piece (3 mm diameter spot separation) Paper). The components to be measured were extracted from the paper pieces. In this extraction, the following six extraction conditions were compared and examined (extraction temperature: 25 ° C).

 1) Type of extraction buffer:

 0.1% Tween-20 contained 0.imo1 / 1 / Ύris-HCl buffer (pH 7.4) and phosphate buffered saline (pH 7.2)

 2) Extraction: 200〃 1, 250〃 1, 300 \

 3) Minute of extraction solution;: 1 50 K 1 25 1

 4) Number of 3 mm Φ spot separation sheets for extraction:

 1, 2, 3, 4, 5

 5) Extraction time:

 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours

6) Tween-20 concentration in Tris-HCl buffer for extraction:

0.1%, 0.2%, 0.3%, 0.4% Using the various extracts (extracts) obtained as described above as samples, use the following measurement kit ^, Each measurement was performed.

(1) Measurement of blood thyroxine (τ _; )

 Measurement of blood thyroxine (（,) is carried out using Μ— “Koninku” (trade name: US, manufactured by Chinoku Co., Ltd., Diagnostics).

 The measurement was performed as follows.

 1) Transfer a specified amount (25 / i 1) of the serum extract (sample to be measured) extracted from b (area: 2 x 10 mm) of blood separation sheet 1 to a 12 x 75 mm Zmm polystyrene test tube. Dispense. Dispense the standard product in the same manner.

 2) Next, add 1001 of tracer reagent (component; outer needle: thyroxine ['!]), Serum albumin, PBS (Phosphate Buffered Saline) and others to each test tube. Dispense.

 3) Dispense 500 µl of the immobilized antibody (components: iron microparticles bound with heron anti-thyroxine antibody, iron serum albumin, PBS and others) into each test tube.

4) Shake the test tube on a vortex mixer for 3-4 seconds and mix at room temperature. Incubate.

 5) Decant the test tube rack with the test tubes set in the magnetic separator, and remove the supernatant. After decanting, place the inverted rack on absorbent paper and drain for 3 minutes. Finally, lift the rack and gently tap it several times on water-absorbing paper to completely remove the test tube droplets.

 6) Remove the test tube rack from the magnetic separator and measure the radioactivity of sediment in each test tube using a gamma counter. The obtained results were compared with the results obtained using the serum samples (serum prepared by the usual method (centrifugation method)) indicated by the above MT, “Coating”. The results are shown in FIG. A good correlation was found.

(2) Measurement of hemoglobin A _1C (HbA, c)

 Hemoglobin ,, (HbA, c) was measured using Rapidiat HbA (trade name: sold by Fuji Repio Co., Ltd.).

 1) Extract the red blood cells (area: 2 x 10 mm) of the blood separation sheet 1 using the sample diluent supplied with the HbA / standard reagent. Add 500〃1 of the sample dilution liquid per 51 red blood cells, and lyse the sample.

 2) Add the latex reagent 300 / ^ 1 to the sample obtained in 1) or 8/1 of the control Hb A ,. solution dispensed into the test tube, mix and incubate at 37 ° C for 5 minutes after mixing. To remove.

3) Anti-HbA _lc reagent reagent (containing anti-human hemoglobin A _IC mouse monoclonal antibody, 79 g / ml) Dissolve 10 ml of the attached anti-Hb A, agent dilution solution (10 ml) and dissolve The anti-HbA, r. Agent and this anti-HbA! c Add 1001 to a test tube, mix and incubate at 37 ° C for 5 minutes to perform antigen-antibody reaction.

4) Using a spectrophotometer, measure the turbidity (absorption) of the sample and the control HbA _IC solution at 660 nm with purified water as a control. The obtained results were compared with the results obtained using the blood samples indicated by Ravidia Auto HbA1 ₍ red blood cell samples prepared by the usual method (centrifugation method)). The results are shown in Fig. 13. Good correlation was found. Ί 8 Example 2

 The blood separation sheet [Hemasep and blood fraction 鹏 (standard: Η Μ 8i05) (brand name); Germanic Science Japan Co., Ltd. (Note: Name after the merger of Nippon Pall Corporation)] The sample protection container of the present invention having the cut blood separation sheet of a specific size as the blood separation sheet 1 was prepared.

 Using the sample protection container of the present invention having a blood separation sheet of each size, a predetermined amount of whole blood collected on the previous day is collected and dropped at room temperature at "a: blood drop site of the blood separation sheet". Blood was absorbed by the separation sheet. At the same time, we observed the blood development pattern, especially the serum development pattern (including the area). Blood separation sheet size (L x W):

 (A) 70 concealed (L) 3 mm (W)

 (B) 70 thigh (L) X 5 mm (W)

 (0 70 mm (L) x 7 mm (W)

 (D) 70 mm (L) x 10 圆 (W)

 (B) 70 irni (L) 10 mm (W)

 (F) 70 iran (L) x 10 圆 (W) In the blood separation sheet of (E) above, there is a slit in the center of the sheet (filter paper) along the length direction (L axis). It is. In the blood separation sheet of (F), the entire surface was pressed or linearly pressed on the surface. Pressing was performed at a temperature of about 24 ° C, a humidity of about 62¾, and a pressure of about 100 kgs / cnr.

 FIGS. 14 to 25 show the results of the development and the turn of each blood, which was sufficiently developed and dried.

In the figure, a strip-shaped partial force, which is located in the middle of each, is a separation sheet (cut), and the portion surrounded by a square outside is a separation sheet fixing stand. Represents a piece of paper and is shown as being in duplicate. The dotted line outside the strip-shaped separation sheet fragment indicates that the separation sheet is a protection sheet? S has been Therefore, a boundary between a space area formed by the protective sheet and the fixing sheet and a contact area between the protective sheet and the fixing sheet are shown. In other words, since there is a close contact portion (each outer region) between the protective sheet and the mounting sheet, a container is formed, and as a result, blood that has been dropped and absorbed or penetrated, or serum that has been developed, etc. Does not leak out.

 FIGS. 14 and 15 show the results of the blood separation sheet of (Λ) above, using two of the liquid samples Α and 、. In FIG. 14 (1), 10 〃1 was used, and In (2), 20 〃1, in (3), 30 〃1, in (4), 401, 50 ml in Figure 15 (5), 60 ml in (6), (7) shows the result of dropping 70〃1. In (2) of Fig. 14, it is observed that the yellow serum part develops in a V-shape, indicating that the serum moves quickly at the edge of the sheet. The same is observed for (3) in Fig. 14.

 Fig. 16 and Fig. I7 show the results of the blood separation sheet of (B) above, using two blood samples A and B, respectively. In (2), 30 〃1, in (3), 40 fi l, in (4), 50 〃1, in (5) in Fig. 17, 60 〃1, and in (6), 70 〃1 (7) shows the result of dropping 80 801 and (8) shows the result of dropping 90 u \. In (1), (2), (3) and () in Fig. 16, the yellow serum part was observed to develop in a V-shape, and the serum power was observed at the edge of the sheet. <You can see that it is moving quickly. In Fig. 17 (5), the yellow serum part reaches the end, but there is a part where the serum is not soaked in the center part of the sheet. To be observed.

Fig. 18 and Fig. 19 show the results of the blood separation sheet of (C) above, using two blood samples E and F. In Fig. 18 (1), respectively, 20〃1 was obtained. the same (2) in 40 〃1, the same (3) in 60 〃1, the (4) in 80 _W l, 1 9 of the (! 5) in] 00 l, the same (6) This shows the result of dropping 120 jl. In (2) and (3) of Fig. 18, the yellow serum part is strongly observed to develop in a V-shape, indicating that the serum moves quickly at the edge of the sheet. . Also, in () in FIG. 18, the yellow serum part reached the end, but the central part of the sheet was not impregnated with serum, and it was observed that there was a part. FIGS. 20 and 21 show the results of the blood separation sheet of (D) above, using two blood samples C and D, respectively. In FIG. The result of dropping 60 1 in (2), 80 〃1 in (3), 100 \ in (4), 120 ul in (5) in Fig. 21 and 140 ul in (6) in Fig. 21 Is shown. In Fig. 20 (1), (2), (3) and (4), it can be observed that the yellow serum part develops in a V-shape. You can see that the serum is moving fast. In (5) of Fig. 21, it is observed that the yellow serum portion has a portion that has not penetrated the serum at the center of the force reaching the end.

 FIGS. 22 and 23 show the results of the blood separation sheet of (E) above, using two liquid samples C and D. In (1) of FIG. In (2), 60 〃 1; in (3), 80 〃 1; in (4), 100 w 1; in (5), 120 \ in FIG. 23; and 140 u in (6). The result of dropping \ is shown. In any case, it was not observed that the yellow serum portion was not soaked in the center of the sheet placed in the sample protection container.

 FIGS. 24 and 25 show the results of the blood separation sheet of (F) above, in which 80 ul of each was dropped using two blood samples A and B, respectively. In (1), the unprocessed sheet is pressed, in (2), the sheet is pressed all over the sheet, and in (3), a single line is pressed linearly along the length direction (L). In (4), the sheet attached by pressing two linear lines along the length direction (L axis) is attached, and in (5) in Fig. 25, the sheet is attached in the length direction (L axis). The figure shows the result of using a sheet formed by pressing three lines in a line along the line. In (3), (4) and (5) in Fig. 24, it was observed that the yellow serum was moving quickly even in the linear line area, and was placed in the sample protection container. It was not observed that the yellow serum portion was soaked in the center of the sample and was not present. As a result of the experiment, the sheet (filter paper) in which the surface of the blood separation sheet was subjected to a full or linear press process was compared with the non-calorie sample in the spread pattern (pattern including area) of the serum; It was strongly observed that it was changing.

The sheets (filter paper) in (A) to (D) above are obtained by cutting the sheet (filter paper) with a machine, but only on both sides of the sheet (filter paper) (the cut section and its vicinity). 5] It develops (extends) quickly, and as a result, the serum part develops in an arc. In other words, the ability to obtain serum equivalent to the sheet (filter paper) area <the ability to be difficult> is understood. On the other hand, it is clear that sheet (filter paper) in (F) above solves these problems. This is thought to be caused by the faster blood development speed at the crimped part of the sheet (filter paper). Also, in the sheets (filter paper) of (A) to (D) above, it is assumed that considerable pressure is applied to the cut section, and as a result, the serum portion develops in an arcuate manner. it is conceivable that. Therefore, even if the width (W) of the sheet (filter paper) is widened, the serum spreads quickly only on both sides (near the cut part) and is not spread almost uniformly on the sheet (filter paper). It turns out to be a problem. In the figure, the black-colored part of the sheet paper) indicates the part corresponding mainly to the part where blood was dripped, and the dark, red-purple brown to dark, dark brown area Is supported. Next, in the sheet (filter paper) in the figure, the shaded area is a light red-purple brown to light brown (lighter color than the black painted area), mainly red. It is thought to correspond to the part corresponding to the developing part (retained part) of blood cells, etc., followed by a border part indicated by dense spots ^, which is an extremely pale reddish purple It is brown to pale dark brown (more lightly colored than the shaded area), and is considered to be the part corresponding to hemoglobin and other components produced by hemolysis. Then, in the sheet (filter; ¾) of the figure, the area (spread relatively wide) that is lightly spotted above the hatched portion (in the spreading direction) has a light yellow color. This corresponds to the area where the serum is developed (retained). The unprocessed sheet shown in (1) in Fig. 24 was cut specially as a test sump-no-re, sharply by hand without applying pressure, and good results were obtained. Is what it is.

Thus, in order to ensure efficient and reliable sample retention of blood and the like, the above-described prevention of the arc-shaped or V-shaped expansion is required. For this purpose, the blood separation sheet is sharpened with a sharp blade. It can be seen that it is important to prevent the crimping of the cut surface as much as possible by cutting, or to press intentionally to make the spread of serum uniform. Such a sample protection container having a blood separation sheet having characteristics of developing serum <uniformity also constitutes a feature of the present invention. Industrial applicability

In the present invention, a method is used in which a blood sample is immersed in one end of a synthetic polymer fiber structure, and a blood cell component and a serum component are naturally separated.In this container, a trace amount of blood can be separated and collected, and further obtained. In addition, the sample has exactly the same strength or little change in components as those collected by conventional centrifugation, or has little effect such as hemolysis. According to the present invention, the blood separation sheet in the specimen protection container is a strip-shaped synthetic polymer fiber structure having an appropriate width, and the blood cell component and the serum component separated from the blood are combined. The specimen itself can be recognized and handled. Therefore, it has excellent handling performance as a storage container that can hold from blood separation to sample storage and transport in a single device as a blood separation sheet and a sample having a measurement component carried on the sheet. The container of the present invention is different from the conventional spitt

 1) It is easy to handle in a compact sheet or film container with high safety, and it can be cut easily with scissors.

 2) By using a material that can be incinerated, sample disposal can be performed easily and safely.

 3) Since the same device and container can be used from blood collection to measurement, intermediate tasks (for example, centrifugation and dispensing operations) are not required, or such tasks can be performed easily.

 4) This container is extremely easy to remove and bulky because the sample, which is a separation sheet, is sandwiched and adhered and protected in a strip shape.

 5) A transparent sheet can be used on one side of the container so that the separation status can be visually checked, and the scale can be easily set, so that separated test components can be used. The length of the sample can be cut off, the sample is taken, the above advantages are great,

6) A blotter that absorbs excess blood on the lower surface of the blood dropping part of the blood separation sheet. Operability can be significantly improved by using a container (with the extra dropping blood absorbed and separated with an appropriate amount of blood).

 7) Identification can be made easily by attaching a label with patient (specimen) information on one side of the container (information is information using a specimen number or barcode).

 8) One side of the container is made into one sheet, a plurality of specimens (blood separation sheets) are arranged, and the blood dropping part can be in a non-contact state with the next specimen. Surfaces, where individual specimens may be perforated to provide individually removable containers, and

 9) A plurality of sample containers can be created on one sheet, and sample containers can be easily made into sample container sheets with perforations that can be individually removed.

 Another advantage of collecting lilL ± is that the ability to separate components that can be measured from a very small amount of blood (easy) makes it relatively easy to collect samples for newborns and infants, which were previously difficult to collect for testing. And more important inspection information can be obtained safely and quickly. The ability to store or Z and transport specimens in a somewhat dry state <possible, has great advantages.

Claims

The scope of the claims 1. (a) S-permeability and Z-area where the body fluid to be separated is allowed to be adsorbed,  (b) a zone allowing the infiltrated and Z or adsorbed bodily fluids to undergo a separation process according to the principles of mouth chromatography.  (c) An area that allows components in the separated bodily fluid to be kept separated A sample protection container, characterized in that at least the area (c) is protected.  2. The protection is characterized in that it is provided in such a manner that substantially no exposed parts are formed in a region that allows components in the body fluid subjected to the chromatographic separation to be kept in a separated state. The sample protection container according to claim i, wherein  3. The specimen protection container according to claim 1 or 2, wherein the protection is performed by detachably covering with a sheet in a sandwich type.  4. The protection means is composed of two sheets, one of which is a sheet which constitutes the base, and which has a sticky box surface which can be repeatedly pasted and peeled on at least a part thereof. A sample protection container according to any one of claims 1 to 3, characterized in that:  5. The protective means consists of two sheets, one consisting of a sheet that is at least partially translucent and visible therethrough, and the other being repeatedly glued or peeled over at least the-part. 5. The sample protection container according to any one of claims i to 4, wherein the sample protection container is made of a sheet having an adhesive surface capable of being peeled off. 6. The region according to claim 1 (a), (b) and (c) has the property of being able to separate whole blood into components such as blood cells and serum components or plasma components by one principle of chromatography. The sample protection container according to any one of claims 1 to 5, wherein the sample protection container has properties of a directional separation sheet having a fibrous structure. 7. A sample protection container characterized in that the directional separation sheet for blood is protected.  8. Directional separation sheet force <, characterized in that it has a property of being able to separate whole blood into components such as blood cells and serum components or plasma components by one principle of chromatography. Sample protection container.  9. The directional separation sheet is developed by chromatographic development in one specific direction from the site where the test blood can be received, and whole blood is converted into clots and serum components, or blood cells and plasma components. At least the area of the directional separation sheet that holds the serum component separated from the blood clot or the blood fatigue component separated from the blood cell component. 9. The sample protection container according to claim 7, wherein the sample protection container is provided.  10. A strip-shaped blood separation sheet is fixed on a substrate sheet, and the blood separation sheet is  (a) a zone for penetration and Z or adsorption of the blood to be separated and (b) An area where the permeated and Z- or adsorbed blood is subjected to a separation treatment based on the principle of chromatography and the separated serum or plasma is retained. A specimen protection container characterized in that at least the area of (b) is protected by a protective sheet.  1 1. A strip-shaped blood separation sheet is fixed on a base sheet, and the blood separation sheet is  (a) an area for penetration and Z or adsorption of the blood to be separated and (b) an area in which the infiltrated and Z- or adsorbed blood is subjected to a separation treatment by a chromatographic principle, and the separated serum or plasma is retained. At least the area of (b) above is protected by a protective sheet, and the liquid to be permeated and Z- or adsorbed to the area of (a) above to separate it into serum or plasma. The sample protection container is characterized in that serum or plasma power is maintained in the region (b). 1 2. A blood separation sheet is available from Hemasep L (trade name: pa1, NY, USA). Claims characterized by the fact that it is available from Iha Hemasep L Blood Separation (trade name: German Man Science Japan, Inc. (Note: name after the merger of Pall Corporation)) 0 or 11 Sample protection container.  13. The sample protection container according to any one of claims 1 to 12, wherein the sample protection container substantially has the configuration shown in Fig. 1 as a basic component.  14. Blood separation cut into strips of width (W) 1 to 1 O mm, length (L) 10 to 200 mm, and thickness of 0.05 to 0.50 mm The sheet is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is The blood separation sheet is provided so as to cover the blood separation sheet while leaving the blood drop permeation and the Z or adsorption portion of the blood separation sheet, any one of claims 10 to 13 characterized by the above-mentioned. Sample protection container.  15. The specimen protection container according to any one of claims 1 to 12, wherein the basic form is substantially the configuration shown in Fig. 2.  16. A blood separation sheet cut into strips with a width (W) of 1 to 10 mm, a length (L) of 10 to 200 mm, and a thickness of 0.5 to 50 mm. The blood separation sheet is fixed on a sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is The one provided so as to cover the blood drop permeation and the Z or adsorption part, and the one provided so as to cover the blood separation sheet while leaving the blood drop permeation and / or the adsorption part. The specimen protection container according to any one of claims 10 to i2 and 15, characterized by comprising:  17. The sample protection container according to any one of claims 1 to 12, wherein the sample protection container substantially has the configuration shown in Fig. 10 as a basic component. 18. A blood separation sheet cut into strips of width (W) I ~ 10mm, length (L) 10 ~ 200mm, and thickness 0.5 ~ 0.50mm The blood separation sheet on the substrate sheet is fixed on a substrate sheet, and the blood separation sheet on the substrate sheet is covered with a separation sheet protection sheet. The sample protection container according to any one of claims 10 to 12 and 17, further comprising a window for receiving blood at the permeation and / or adsorption portion. 19. The separation sheet protection sheet must be fixed with an adhesive on the base sheet where the blood separation sheet is fixed so that it can be repeatedly attached and peeled off. The specimen protection container according to any one of claims 10 to 18, characterized in that:  20. The blood separation sheet is sealed with a base sheet on which the blood separation sheet is fixed and a separation sheet protection sheet, wherein the blood separation sheet is sealed. The sample protection container according to any one of 0 to 19.  21. Any one of claims 1 to 20, wherein a scale is provided along the separation sheet on the base sheet on which the separation sheet is fixed. Sample protection container as described.  1 1. A plurality of separation sheets are dried on the substrate sheet, and the plurality of separation sheets fixed on the substrate sheet are separated from each other. 21. The sample protection container according to claim 21, wherein the sample protection container can be covered with a protection sheet. 23. The sample sheet according to claim 1 or 2, wherein a data area for sample management is provided on the substrate sheet where the separation sheet is fixed. The sample protection container according to (1).  24. The method according to any one of claims 1 to 23, wherein a two-dimensional code for specimen management information is provided on the substrate sheet where the separation sheet is fixed. The sample protection container according to any one of the above.  2 5. The base sheet where the separation sheet is fixed, and the Z or separation sheet protection sheet is made of a light-transmitting material so that the test sample components can be visually confirmed. The specimen protection container according to any one of claims 1 to 24, wherein:  26. The sample protection container according to any one of claims 1 to 25, wherein the separation sheet contains a liquid-solid coagulant and an inhibitor as required. .  2 7. The separation sheet (Α) Two or more sheets of the separation sheet having a narrow width (W), which are arranged in the sample protection container in such a manner that the sides of the sheets are closely attached to each other. Force, or  (B) The sheet-shaped fragment, which is made to be capable of uniformly absorbing and developing a body fluid such as blood, and arranged in the specimen protection container. The specimen protection container according to any one of claims 1 to 2G.  2 8. The sheet-like fragment according to claim 27 (B) is obtained by intentionally cutting the large-sized sheet with a sharp knife and the intended cut-off separation sheet. 28. The sample protection container according to claim 27, wherein the sample protection container is selected from a group consisting of a pressed product.