JPS6053845A - Blood separating tube - Google Patents

Abstract

PURPOSE:To perform examination, by providing a fixing agent holding an examining reagent at the surface of a separating agent, which has intermediate specific gravity between serum (blood plasma) and blood clots (blood corpuscles), so that the surface of the separating agent is fixed in a shape other than a plane, which crosses the central axis of a blood separating tube at a right angle, and performing quick, positive centrifugal separation. CONSTITUTION:A thixotropic separating agent 13 has intermediate specific gravity between serum or blood plasma and blood clots or blood corpuscles. An examination reagent 15 is eluted in the blood when the reagent is contacted with the blood. A fixing agent 14, which is dissolved in the blood, holds the reagent 15. The fixing agent 14 with the reagent 15 is coated on the surface of the separating agent 13 in a shape other than a plane, which crosses the central axis ofa main body 11 of a blood collecting tube 10 at a right angle, i.e., in a shape of a slanted plane with respect to the axis, or a concave or convex surface, or the like. A plug 12 is provided. Pressure is reduced, and the tube is used as a blood separating tube. The collected blood is injected through a blood collecting needle 17, which is penetrated into the plug 12. The separating tube 11 is tumbled and the contents are mixed. The fixing agent 14 and the reagent 15 are dissolved. Then centrifugal separation is performed. Thus quick, positive separation and accurate examination are performed.

Description

[Detailed description of the invention] ■Background of the invention Technical field The present invention relates to blood separation tubes for clinical testing.

BACKGROUND TECHNOLOGY Conventionally, as a blood sample 741'ri for clinical testing, a bottomed blood collection 'i' body with one end open and the other end closed 17, and a stopper that seals the opening of the blood collection tube body have been used. , the blood sampling?i
- A thixotropic separating agent that is housed in the body and has an intermediate specific gravity between the serum or plasma component to be separated and that of the blood clot or blood cell component, and a part of the blood collection tube that is located within the main body and from the blocking agent. − consists of a testing agent provided at +fi+
The test drug is dissolved in the blood by contact with the test drug for one night, and the blood in which the test drug has been dissolved is centrifuged to isolate blood or blood cell components from the blood. ' has been proposed.

The above-mentioned oil-containing tube forms a strong intermediate layer of separating agent between serum or plasma components and blood clots or blood cell components by centrifugation after blood collection. This makes it possible to avoid the risk of contamination of blood cells or blood cells into serum or plasma during serum or plasma collection.

In addition, the blood separation tube already proposed above prevents the test drug from being taken into the separation agent by placing the test drug at a position separated from the separation agent, and prevents the test drug from being taken into the separation agent. The entire amount is dissolved in 1r11 serum or plasma to ensure a stable amount of the required test drug in serum or plasma.

However, even if the test agent is separated from the separating agent at the manufacturing stage as in the blood separation tube already proposed in -1-, the separating agent is generally susceptible to thixotropy due to the effects of heat, vibration, etc. It is difficult to eliminate the possibility that the test agent will be incorporated into the separating agent, which undergoes large thorax changes during the transportation and use stages. If the test drug is incorporated into the separation agent as described above, there will be a shortage of the test drug Fli, which is required in the serum or plasma, and a negative test result may be obtained. becomes impossible.

Also, 1. In the case of the blood separation tube already proposed in IJlj, since the separating agent is easily thixotropic as described in 1-1, even if centrifugation with the tube axis direction as the rotation radius direction after blood collection is performed, In order to achieve a 11f capability for rapid flow of the separating agent in the direction of the tube axis downstream of Tsukisaku, the surface of the separating agent was set to a predetermined shape other than the 1i plane perpendicular to the central axis of the blood collection tube body at the manufacturing stage. Even so, the surface of the separating agent during use has a 111 plane perpendicular to the central axis of the blood collection tube body, or an irregular shape, making it difficult to perform the centrifugation operation quickly and reliably.

II. Purpose of the Invention The present invention reliably prevents the incorporation of test reagents into the separation agent, enables rapid and reliable centrifugation, and dissolves the necessary test reagents. It is an object of the present invention to provide a blood separation tube that can be used to separate serum or plasma components without the risk of contamination with serum or blood cell components and to obtain correct test results.

■Structure of the Invention In order to achieve the second object, the blood separation tube according to the present invention includes a bottomed blood collection tube main body with one end open and the other end closed;
a stopper that seals the opening of the blood collection tube body; a separation agent housed in the blood collection tube body and having a specific gravity intermediate between that of the serum or plasma component to be separated and the blood clot or blood cell component; It consists of a fixative that is adhered to the surface and fixes the surface of the separating agent in a shape other than a plane perpendicular to the central axis of the blood collection tube body, and a test agent held in the fixative. The fixative is eluted into the blood and the testing agent is dissolved into the blood upon contact with the blood, thereby separating blood clots or blood cell components from the blood.

Further, in the present invention, the fixative is applied to the surface of the separating agent by freeze-drying an aqueous solution containing a test drug.

Further, in the present invention, the fixing agent is polyvinylpyrrolidone.

(JJ of the invention: weight description) FIG. 1 is a sectional view showing a blood collection tube io according to an embodiment of the present invention. 1-type blood vessel 101'', a bottomed I black blood vessel body 11 with one end open and the other end occluded, and an open 1 blood collection tube body 11.
4↑ body 12, which is housed inside the blood collection tube body 11 and is the serum or plasma component to be separated.011
In addition, a thixotropic separating agent 13 having a specific gravity intermediate to that of blood cell components is deposited on the surface of the separating agent 13 without contact with blood, and the surface of the separating agent 13 is aligned with the central axis of the blood collection tube body 11. A fixing agent 14 to be fixed in a tilted surface shape, and a rule 14
The fixative 14 is eluted into the blood upon contact with the blood and the test drug 15 is held in the test drug 15.
To avoid dissolution of the test drug 15 into the blood, blood in which the test drug 15 has been dissolved is centrifuged to isolate blood clots or blood cell components from the blood.

The blood collection tube body 111 is made of transparent glass, plastics, etc., and the stopper 12 is made of butyl rubber, styrene elastomer, etc. The stopper 12 seals the inside of the blood collection tube body 11 and is capable of forming and maintaining a predetermined depressurized state corresponding to a predetermined amount of blood to be collected inside the blood collection tube body 11, and as shown in FIG. It is possible to pierce the blood collection amount 17 provided in the blood collection holter 16.

The separation agent 13 is located on the bottom side of the blood collection tube body 11 before blood collection, and is substantially hydrophobic and has fecal collection properties (chickentropy), and is substantially inert to blood. and has a specific gravity intermediate between that of the serum or plasma component separated as described above and that of the blood clot or blood cell component. In addition, the surface of the separation agent 13 is fixed in an inclined plane with respect to the central axis of the blood collection tube body 11 by the fixing agent 14 as described above, so that the surface of the separation agent 13 is not taken in the test agent 15, and the surface of the separation agent 13 is fixed in the axial direction of the tube. Under the action of centrifugal force in the radial direction of rotation, rapid flow in the axial direction of the tube enables replacement with serum or blood cell components. Therefore, when the blood collection tube 10 from which the blood was collected is placed in a centrifuge, the separating agent 13 exhibits fluidity and moves to the boundary between the two components, and as the centrifugal force stops, the two components become phase W. Forms an isolated wall in a solid or non-flowing state.

The fixative 14 needs to be iif soluble in blood. This is because it is eluted into the I/a constant test solution 14 at the same time as Steller's blood, and the test drug [5] is quickly dispersed and dissolved in the blood. The fixative 14 is also desirably a suitable adhesive, non-volatile, hematologically inert, etc. Examples of the fixative 14 include polyvinylpyrrolidone, polyvinylpyrrolidone, Water-soluble (11 silicone, polyethylene glycol, dextran, cellulose derivatives such as carboxymethylcellulose, hydroxypropyl, methylcellulose, etc.)

As the testing agent 15, a glycolytic 11n+Iz agent, a coagulation promoter, an anticoagulant, etc. are used. Glycolysis I11. It
Examples of Z agents include thorium fluoride and thorium 1,000-iodoacetate; examples of coagulation promoters include protamine sulfate or thrombin-like enzymes contained in snake venom; and anticoagulants include C]heparin salts.

Here, the fixing agent 14 is applied to the surface of the separating agent 13 by freeze-drying an aqueous solution containing the test agent 15. That is, this blood collection tube 10 is prepared by injecting, for example, a 1 to 2 W/V% polyvinylpyrrolidone aqueous solution containing an anticoagulant onto the surface of the separating agent 13 that has been given a predetermined surface shape in the blood collection tube main body 11, and freeze-drying it. formed by Therefore, in this blood collection tube 10, the fixative 14
holds the test agent 15 from the freeze-drying stage, and the test agent 15 does not scatter during freeze-drying. It is kept dispersed and is not taken into the separating agent 13.

■Specific operation of the invention First, as shown in FIG.
B is the stopper 1 of the blood collection tube 10 inserted into the blood collection holder 16
Blood collection tube main body 1 in a depressurized state by piercing 2
Collect blood inside 1. At this time, the blood ejected from the inner end 17B of the blood sampling needle 17 is mixed with the fixing agent 14 of the separation agent 131- located on the bottom side of the blood sampling tube body 11, and the test drug 15.
The fixing agent 14 is quickly eluted into the blood, and the test drug 15 can be dissolved into the blood.

After the blood is collected, the blood and the test drug 15 are mixed by inversion. Here, since the ratio does not change under the fixation by the fixing agent 14 during transportation and use of the preparation 131, the test drug 15 is not incorporated into the preparation 13 and is mixed by tumbling as described in 1. All 15 testing drugs by! - is dissolved in the blood, and there will be no shortage of the test drug 11O, which is considered safe in serum or plasma.

Next, the sampled tube 10 described in 1 is placed in a centrifuge.

By this centrifugation, the blood is divided into serum or plasma components 18
And blood f! K or blood cell component] separated into 9 parts, both components 1
8.19 is fractionated by the separating agent 13 and isolated to ill If, as shown in FIG. Here, the surface of the separation agent 13 is fixed by the fixing agent t4 on a plane that is inclined with respect to the central axis of the blood collection tube body 11, so that the direction of the central axis of the blood collection tube body 11 is the direction of the rotation radius. Under the action of centrifugal force, the separating agent 13 flows rapidly, allowing replacement of the blood clot or blood cell component 19.

- Serum or plasma component 18 separated as described below.
Since the required amount of test drug 15 is mixed with the blood clot or blood cell component 19 and is separated from the blood clot or blood cell component 19 by the separation agent 13, the test drug 15 is not contaminated by the blood clot or blood cell component 19 and can be used for the correct test. It becomes possible to use it as a sample.

Further, the blood collection tube 10 can be used as a sample storage container as it is after separating the serum or plasma component 18 and the blood clot or blood cell component 19, and even when the blood collection tube 15 is stored or transported, both components 18. 19 to ensure that the possibility of intermixing is excluded. Further, the serum or plasma component 18 as a sample stored in the blood collection tube 10 can be taken out very easily and efficiently at any time by decantation, pipetting, or the like.

The surface shape of the separating agent 13 before surface measurement to be fixed by the fixing agent 14 is a concave shape with a concave center part as shown in FIG. 4, and a protruding center part as shown in FIG. 1.
It may also have a convex shape.

■Effects of the Invention As described in 1-, the blood separation tube according to the present invention includes a bottomed blood collection tube body with one end open and the other end closed 17, and a stopper that connects the opening 11 of the blood collection tube body. , a separation agent which is housed in the blood collection tube body and has an intermediate specific gravity between serum or plasma components and blood clots to be separated by 1; It consists of a fixing agent that identifies the surface of the separation agent in a shape other than a plane orthogonal to the central axis of the blood collection tube body, and a test agent held in the fixing agent, and the fixing agent is fixed when in contact with blood. This method causes the elution of the agent into the blood and the dissolution of the test agent into the blood, and separates blood clots or blood cell components from the blood.

Therefore, in order to reliably prevent the incorporation of the 4Φ Sagawa drug into the separation agent, b) the fixative and the test drug are simultaneously dissolved in the blood; Serum or blood obtained by dissolving the necessary test drug part can be fractionated without the risk of contamination between the components or blood cell components, making it possible to obtain correct test results.

Further, the present invention provides a fixing agent that holds the testing agent on the surface of the separating agent by applying the fixing agent to the surface of the separating agent by freeze-drying an aqueous solution containing the testing agent. It is possible to form a stable film of the agent.

[Brief explanation of the drawing]

FIG. 1 is a sectional view showing a liquid separation tube according to an embodiment of the present invention, FIG. 2 is a sectional view showing the separation tube inserted into a blood collection holder, and FIG. 3 is a state in which blood is collected using the separation tube. FIG. 4 is a cross-sectional view of a main part showing a modification of the present invention, and FIG.
The figure is a sectional view of a main part showing another modification of the present invention. 10... Blood collection tube, 11... Blood collection tube body, 12...
Plug body, 13... Separating agent, 14... Fixing agent, 15...
・Test drugs. Patent Applicant Chirusen Co., Ltd. Agent Patent Attorney Osamu Shiokawa 2 Figure 2 Figure 3 2 Figure 4 Figure 5

Claims (3)

[Claims] (1) A bottomed blood collection tube body with one end open and the other end closed, a stopper that seals the opening of the blood collection tube body, and a serum or plasma component to be separated contained within the blood collection tube body. a separating agent having a specific gravity intermediate between that of blood clots or blood cell components; and a test drug held in the fixative, which causes elution of the fixative into the blood and dissolution of the test drug into the blood upon contact with blood; A blood separation tube that separates clots or blood cell components from blood. (2) The blood separation tube according to claim 1, wherein the fixative is adhered to the surface of the separation agent by freeze-drying an aqueous solution containing a test drug. (3) The blood separation tube according to claim 1 or 1, wherein the fixative is polyvinylpyrrolidone.