WO1998010283A1 - Recipient de protection d'echantillon solidaire d'une feuille de separation de fluides corporels - Google Patents

Recipient de protection d'echantillon solidaire d'une feuille de separation de fluides corporels Download PDF

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Publication number
WO1998010283A1
WO1998010283A1 PCT/JP1997/003103 JP9703103W WO9810283A1 WO 1998010283 A1 WO1998010283 A1 WO 1998010283A1 JP 9703103 W JP9703103 W JP 9703103W WO 9810283 A1 WO9810283 A1 WO 9810283A1
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WO
WIPO (PCT)
Prior art keywords
sheet
blood
sample
separation
protection container
Prior art date
Application number
PCT/JP1997/003103
Other languages
English (en)
Japanese (ja)
Inventor
Yoshihiko Abe
Masanori Oka
Jun-Ichi Satake
Original Assignee
Srl, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Srl, Inc. filed Critical Srl, Inc.
Publication of WO1998010283A1 publication Critical patent/WO1998010283A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/60—Construction of the column
    • G01N30/6052—Construction of the column body
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components

Definitions

  • 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 ⁇ 3 ⁇ 4 * 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 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.
  • 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.
  • a blood clot or the like which mainly contains blood cell components such as red blood cells, and a serum or plasma component.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • a blood collection tube test tube
  • the sample is bulky, and the sample is stored in a liquid state or transported, so that handling is inconvenient.
  • 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. .
  • 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.
  • 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;
  • 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.
  • a serum or sample for the sample can be obtained by a simple method.
  • 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.
  • 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.
  • the present inventors can easily handle the 3 ⁇ 4ftiii solution, and can easily transport and handle the 3 ⁇ 4ftiii 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 ⁇ 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
  • a sample protection container characterized in that at least the area of (c) above is protected.
  • 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.
  • 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 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 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 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.
  • 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
  • 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,
  • 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.
  • a method for protecting a measurement sample which comprises protecting at least the area (c).
  • 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 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
  • 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.
  • 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,
  • 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.
  • 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.
  • 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.
  • the present invention provides:
  • a strip-shaped blood separation sheet is fixed on a base sheet, and the blood separation sheet is
  • a strip-shaped blood separation sheet is fixed on a base sheet, and the blood separation sheet is
  • 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.
  • 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).
  • 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.
  • 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 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.
  • the specimen protection container according to any one of the above items 63-3 to 6 (i) and [69], wherein
  • 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
  • the sample protection container according to any one of to
  • 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,
  • 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
  • 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),
  • 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.
  • 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 one-liquid coagulant is selected from the group consisting of oxalate, citrate, ethylenediaminetetraacetate, and heparin or a salt thereof.
  • the solid solution coagulant is selected from the group consisting of sodium citrate, sodium edetate, sodium hebalin, and heparin. ] Described sample protection container,
  • sample protection container according to the above [88], wherein the sample protection container is an inhibitory agent ⁇ trazirol.
  • the present invention provides
  • 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 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 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.
  • two or more sample protection containers described in 2) above are provided.
  • 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.
  • 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).
  • a relatively small or minute amount of a body fluid 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.
  • 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.
  • 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.
  • 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 tetraacetic acid
  • 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).
  • sample protection container of the present invention has a structure for protecting a region in which a component in a body fluid subjected to the chromatographic separation has been retained.
  • 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.
  • 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.
  • synthetic polymer resins 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.
  • 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.
  • a predetermined body fluid penetrating ability and Z or adsorption ability can be obtained.
  • 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.
  • ⁇ 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 ⁇ 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.
  • 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.
  • hydrophilic polyimide materials having controlled surface properties.
  • Particularly preferred are hydrophilic and microporous non-cortical boriamid materials having controlled surface properties.
  • 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:
  • Inclusion of a surface carboxyl component can be produced by simultaneously treating the niobium with a cobolimer containing a large amount of carboxyl groups.
  • 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.
  • 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.
  • 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.
  • 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.
  • the critical value of the surface tension that can impart wettability to the material (mat) 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.
  • the critical value of surface tension for imparting wettability is as high as possible.
  • 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.
  • a high velocity of gas usually air
  • 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.
  • 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.
  • ⁇ 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.
  • 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.
  • a heating die may be used to make a special shape, or the pore size between the regions to be formed may be changed.
  • 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.
  • 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.
  • plasma 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.
  • 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.
  • an inhibitor such as trazinol or the like.
  • 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.
  • 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 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.
  • 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 ⁇ ⁇ ⁇ ) 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.
  • the directional separation sheet may be provided with a structure having a strong capillary suction force suitable for holding serum or plasma.
  • 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 ⁇ [Product name: German Science Japan K.K. : Available from Nippon Pall Co., Ltd.).
  • a directional separation sheet 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.
  • 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.
  • the separation sheet 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.
  • 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.
  • “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.
  • 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.
  • 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.
  • the line is formed by pressing the sheet under a pressure of 40 to 100 kgs / cm- '.
  • the present invention provides a specimen protection container characterized in that the directional separation sheet for blood is protected.
  • the structure, form, or shape when protecting a structure holding a sample, may be such that the sample is stably held.
  • 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. .
  • 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)).
  • Masseb L Hern asep L
  • 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.
  • a structure achieved by coating a structure holding a specimen in a sandwich type with a sheet may be mentioned.
  • 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.
  • 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.
  • 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.
  • 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.
  • the adherend object to be adhered
  • the adherend is connected by some kind of connection (through an adhesive between the dents and narrow gaps on the adherend surface, including ii ⁇ ).
  • 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.
  • 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.
  • 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.
  • polystyrene-butadiene rubber examples 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.
  • 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 polyisobuty
  • 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.
  • 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.
  • 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.
  • 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.
  • the symbols such as identification numbers
  • the business and the request information management (mainly by computer) are managed separately, and they are handled based on 1 3 ⁇ 4 another symbol.
  • information is integrated into the report so that it can be managed by medical institutions.
  • an identification symbol, a barcode, or a two-dimensional barcode that can directly describe information is used.
  • 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.
  • 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.
  • the ability to manage large quantities and accurate specimens enables the use of more accurate laboratory tests.
  • 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
  • barcodes are used to make it possible to partially control patient sample collection sites, such as individual management at each date and time.
  • the sample protection container of the present invention is suitable for utilizing such a barcode symbol with high joy and high density.
  • 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.
  • 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 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.
  • 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.
  • the thickness of the strip-shaped membrane is fixed! f ⁇
  • W width of the membrane
  • 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.
  • 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.
  • the size is not limited to the above size, but is preferably B5 size (182 x 2557 mm) and ⁇ 4 size of Japanese Industrial Standard. (2 10>: 2 ⁇ 7 mm), B4 size (2 5 7 x 3 G 4 mm), ⁇ 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.
  • 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))
  • 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.
  • 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.
  • 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).
  • a data application area for specimen management can be provided on the blood separation sheet fixing mount.
  • 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.
  • a transparent (translucent) material (a material that has transparency (translucency) even when colored)
  • 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.
  • 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).
  • the blood separation sheet 1 set on the separation sheet fixing mount 2 may be in a protected form.
  • 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).
  • 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.
  • 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.
  • ⁇ 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.
  • 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.
  • blood can be subjected to separation processing in a relatively new ⁇ ! .
  • a protective paper 4 in the portion a where the blood is dropped, remove it (see FIGS. 2 and 3).
  • 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).
  • 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).
  • 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 ⁇ 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.
  • the blood separation sheet I is kept dry until the sample is adsorbed.
  • Normally applied blood is about 20 to 30 u1.
  • the blood 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.
  • the blood 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
  • 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).
  • 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.
  • the mouth of the bag may be sealed.
  • 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, ⁇ material with excellent temperature resistance (freezing to 50 ° C), 5 material that can be cut easily [6]
  • 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.
  • an adhesive may be applied to the backing 2 in advance so that it can be easily adhered.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ' 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.
  • the protective sheet (5 or 6) can be peeled off before cutting the separation sheet with scissors.
  • 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.
  • 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.
  • a buffer solution pHG.8 to 7.G
  • a lys buffer solution or a phosphate buffer solution as the extraction solvent.
  • the extraction solvent preferably contains a surfactant (preferably, a nonionic surfactant such as Tween-20).
  • a surfactant preferably, a nonionic surfactant such as Tween-20.
  • 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
  • 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.
  • 0-phthalaldehyde 0 PTA
  • ⁇ cCys 0-phthalaldehyde ZN-acetyl-L-cysteine
  • a method utilizing a reaction having specificity such as an enzyme reaction or a ⁇ ⁇ 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 ( ⁇ -HBD), ⁇ -glutamine transpeptidase ( ⁇ -GTP), leucine aminopeptidase (LAP), etc.
  • a specific synthetic substrate or a naturally occurring substrate is used to Or contact measurement, it is often a
  • 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.
  • PCR polymerase 'chain' reaction
  • RT-PCR reverse 'transcriptase' polymerase 'chain reaction
  • Insitu hybridization and the like.
  • an immunological assay utilizing an antibody reaction.
  • 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.
  • TR-FIII time-resolved fluorescence immunoassay
  • Test samples processed using the sample protection container of the present invention can be subjected to various tests.
  • Endocrinological tests including tumor-related tests
  • Endocrinological 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
  • a disposable lancet for fingertip (or earlobe) blood collection 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.
  • the examiner's ears 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.
  • 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.
  • 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).
  • Tween-20 contained 0.imo1 / 1 / ⁇ ris-HCl buffer (pH 7.4) and phosphate buffered saline (pH 7.2)
  • the measurement was performed as follows.
  • tracer reagent component; outer needle: thyroxine ['!]
  • Serum albumin Serum albumin
  • PBS Phosphate Buffered Saline
  • test tube Shake the test tube on a vortex mixer for 3-4 seconds and mix at room temperature. Incubate.
  • Hemoglobin , (HbA, c) was measured using Rapidiat HbA (trade name: sold by Fuji Repio Co., Ltd.).
  • 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.
  • the blood separation sheet [Hemasep and blood fraction ⁇ (standard: ⁇ ⁇ 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.
  • FIGS. 14 to 25 show the results of the development and the turn of each blood, which was sufficiently developed and dried.
  • 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.
  • 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.
  • 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 ( ⁇ ) above, using two of the liquid samples ⁇ and ⁇ .
  • 10 ⁇ 1 was used, and
  • 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.
  • (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.
  • 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.
  • Fig. 18 (1) 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)
  • 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. .
  • 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.
  • FIG. 20 and 21 show the results of the blood separation sheet of (D) above, using two blood samples C and D, respectively.
  • 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.
  • 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.
  • (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.
  • (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.
  • the unprocessed sheet is pressed
  • the sheet is pressed all over the sheet
  • a single line is pressed linearly along the length direction (L).
  • the sheet attached by pressing two linear lines along the length direction (L axis) is attached
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • the sheet (filter; 3 ⁇ 4) 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.
  • 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.
  • a sample protection container having a blood separation sheet having characteristics of developing serum ⁇ uniformity also constitutes a feature of 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
  • 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.
  • 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,
  • 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).
  • 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).
  • 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.
  • specimens blood separation sheets
  • Surfaces, where individual specimens may be perforated to provide individually removable containers, and
  • 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.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un récipient adapté pour séparer, de manière à assurer une mesure, une faible ou très faible quantité de fluide corporel, particulièrement, du sang. En outre, ce récipient est prévu pour être transporté avec fiabilité et stabilité. Ce récipient de protection d'échantillons se caractérise en ce qu'il possède (a) une zone assurant l'adsorption d'un fluide corporel à examiner, particulièrement, du sang; (b) une zone permettant de soumettre le fluide adsorbé à un pré-traitement basé sur le principe de la chromatographie; et (c) une zone assurant le maintien de la séparation des composants du fluide corporel séparés par chromatographie. Cette dernière zone (c) au moins doit être protégée. En particulier, l'invention concerne un récipient de type à feuille dans lequel une feuille de séparation du sang est protégée par une feuille de substrat qui assure sa fixation et une feuille recouvrant une section maintenant les composants du sérum sanguin séparés. Ce récipient est facile à manipuler.
PCT/JP1997/003103 1996-09-05 1997-09-04 Recipient de protection d'echantillon solidaire d'une feuille de separation de fluides corporels WO1998010283A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP25398796 1996-09-05
JP8/253987 1996-09-05

Publications (1)

Publication Number Publication Date
WO1998010283A1 true WO1998010283A1 (fr) 1998-03-12

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ID=17258702

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PCT/JP1997/003103 WO1998010283A1 (fr) 1996-09-05 1997-09-04 Recipient de protection d'echantillon solidaire d'une feuille de separation de fluides corporels

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Country Link
WO (1) WO1998010283A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63501594A (ja) * 1985-10-18 1988-06-16 ケム−エレク・インコ−ポレ−テッド 全血試験方法
JPS63169571U (fr) * 1987-04-24 1988-11-04
JPH05209877A (ja) * 1991-10-03 1993-08-20 Miles Inc 全血の分離及び検定の改良型試験具及び方法
JPH0854387A (ja) * 1980-08-05 1996-02-27 Boehringer Mannheim Gmbh 血液から血漿または血清を分離する器具

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0854387A (ja) * 1980-08-05 1996-02-27 Boehringer Mannheim Gmbh 血液から血漿または血清を分離する器具
JPS63501594A (ja) * 1985-10-18 1988-06-16 ケム−エレク・インコ−ポレ−テッド 全血試験方法
JPS63169571U (fr) * 1987-04-24 1988-11-04
JPH05209877A (ja) * 1991-10-03 1993-08-20 Miles Inc 全血の分離及び検定の改良型試験具及び方法

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