JPH0545186B2 - - Google Patents

Description

[Detailed Description of the Invention] [Field of Industrial Application] This invention is a method for separating a blood sample into blood cell components and plasma or serum components by centrifugation, and then extracting only the plasma or serum components for use in clinical tests. The present invention relates to possible analysis containers.

[Background of the invention]

In clinical testing, tests using blood as specimens provide important diagnostic information, and these tests include hematological tests, microbiological tests, immune serum tests, and clinical chemistry tests. There are many different types. In these tests, whole blood plasma or serum components are used as the specimen, but it is necessary to select the specimen to be used depending on the type of test.
For example, when measuring red blood cell index, white blood cell index, hematocrit value, etc. in a hematological test, whole blood is used as it is, but when plasma or serum components are used as a specimen, after collecting the blood in a blood collection tube,
This is separated into blood cell components and plasma or serum components by centrifugation, and the supernatant, plasma or serum components, is fractionated into another container using a pipette or decantation.

However, the conventional method of separating plasma or serum components has problems such as complicated and time-consuming operations, and errors in collecting test samples. It does not satisfy the conditions of convenience; in other words, when centrifuging and collecting the supernatant using a pipette or decantation, there is a risk that blood cell components etc. may be mixed into plasma or serum components. This is because sufficient skill and caution were required of the operator to prevent such contamination.

In addition, conventionally, in order to clearly separate blood cell components from plasma or serum components and to facilitate preparative separation operations,
A gel-like substance (thixotropic substance) made of plastic beads such as styrene, silicone/silica, etc. that has a specific gravity intermediate between blood cell components and plasma or serum components.
Attempts have been made to use C. as a phase separation material, but these have had drawbacks such as insufficient separation and time required for coagulation to obtain serum components, and the use of supernatant after centrifugation The accuracy, speed, and simplicity of preparative separation operations have not been improved.

Furthermore, in recent years, analytical technology has made remarkable progress, and it has become possible to perform various blood tests using extremely small amounts of blood. An example is dry chemistry in clinical chemistry testing. This dry chemistry uses a dry sheet impregnated with a reagent, supplies the specimen sample to it, causes it to react, and measures the specimen sample by photometrically measuring the change in color density due to the reaction using a wet method. This eliminates the need for operations such as adjusting reagents, preparing reaction containers, processing specimens after use, weighing specimens and reagents, diluting them, and mixing them according to operating instructions, as required in the method. This dry sheet has a reagent layer that selectively develops color by reacting with the sample on a water-impermeable transparent support, and a developing layer on top of which the sample is diffused in an area proportional to its volume. Analytical elements are often used, and testing can be performed by simply supplying about 10 μl of the specimen sample onto the developing layer.

According to the above-mentioned dry chemistry, there is no need to collect a large amount of blood for testing, and there is no physical or mental burden on the test subject, especially in cases where it is difficult to collect blood with a blood collection needle, such as in newborns. Reduce. To collect a small amount of blood, a glass capillary tube is used, a hole is made in the subject's earlobe or fingertip, and the glass capillary tube is applied to the hole to utilize the capillary phenomenon. The blood sample collected in the capillary tube in this way is separated into blood cell components and plasma or serum components by centrifugation, and the separated plasma or serum component is taken out above the capillary tube and used as a specimen sample, but since the tube is thin, The operation was quite troublesome.

[Purpose of the invention]

In view of the above points, this invention separates a collected blood sample into blood cell components and plasma or serum components by centrifugation, and then directly transfers the plasma or serum components to an analytical element without taking them out into a separate container. The purpose is to provide an analytical container that can be applied.

[Structure of the Invention] In order to achieve the above object, the present invention provides a transparent container body having a hollow part made of a capillary tube capable of holding a blood sample in a penetrating manner, and a transparent container body having a transparent container body having a hollow part made of a capillary tube capable of holding a blood sample. An indicator line indicating the amount of blood sample to be collected is provided, and after collecting the sample in the hollow part, the collecting end is sealed and the blood sample is placed inside the hollow part when the sample is placed in a centrifuge with the sealed side outside. A dividing surface that separates blood cell components and plasma or serum components is defined by the boundary surface, and a branch hole communicating from the hollow part to the outside is provided on the plasma or serum component side of the dividing surface with respect to the axial direction of the hollow part. The branch hole is provided at a right angle or inclined toward the plasma or serum component side, so that the plasma or serum component can be taken out independently from the blood cell component through this branch hole. Specifically, the hollow part is a capillary tube, and when the sample is collected into the hollow part and then centrifuged with the sealed side facing outward, plasma is collected from the dividing surface where blood cell components and plasma or serum components are separated. Alternatively, the branch hole is provided on the serum component side, and the branch hole is configured to be perpendicular to the axial direction of the hollow portion or inclined toward the plasma or serum component side.

〔Example〕

Next, the present invention will be explained in more detail with reference to the accompanying drawings.

1 to 4 show a first embodiment of the present invention. In the figures, 1 is a container body molded from a transparent material, and 2 is a blood sample provided so as to pass through the container body 1. It is a hollow part that can be held.
The hollow part 2 is preferably a capillary tube with an inner diameter of 5 mm or less, more preferably 3 mm or less, and has both ends 2a,
2b is open and protrudes from both end surfaces of the container body 1. In this embodiment, the container main body 1 and the hollow part 2 are integrally molded, but the hollow part 2 may be formed by passing a capillary tube through the container main body 1.

Reference numeral 3 indicates an indicator line indicating the amount to be collected when a blood sample is collected using capillary action by applying one end 2a of the hollow part 2 to a perforated part such as an earlobe, a fingertip, or a heel. It is displayed on the outer surface of the main body 1. Of course, when the hollow part 2 is constituted by a capillary tube separate from the container body 1, it may be displayed on the outer peripheral surface of the capillary tube itself.

In addition, when using only plasma or serum components from the collected blood sample as a test sample, apply an anticoagulant (e.g. EDTA salt, heparin) to the collected blood sample.
It is preferable to add or apply a thin layer to the inner wall of the hollow part 2.

4 is a branch hole provided so as to communicate from the hollow part 2 to the outside of the container body 1, and the branch hole 4 is used to separate blood cell components 5 and plasma or serum components 6 in the hollow part 2 by centrifugation, as shown in the second figure. After separation, only the plasma or serum component 6 is taken out to the outside. Therefore, after a blood sample is collected from one end 2a of the hollow part 2 to the indicated line 3, one end 2a is melted or sealed with a suitable sealing member 7, and the sealed side is turned outward as shown in the third figure. The blood cell components 5 separated by the operation of the centrifuge 8 are placed in a centrifuge 8 as shown in FIG.
It is provided on the plasma or serum component side from the dividing surface 9 between the and plasma or serum component 6. Since this dividing surface 9 moves back and forth depending on the blood sample, the branching hole 4
It is preferable that the maximum range of the amount of movement is assumed in advance and provided. Further, the branch hole 4 is perpendicular to the axial direction of the hollow portion 2 or inclined toward the plasma or serum component 6 side. This is to ensure that even if the blood sample penetrates into the branch hole 4 during blood collection, it will be returned to the hollow portion 2 during centrifugation, as described above.

Reference numeral 10 denotes a conical mouth provided at the outer end of the branch hole 4, and the mouth 10 is designed to allow the liquid to drip easily in a bead shape when plasma or serum components 6 are taken out through the branch hole 4. It is something. This mouth part 1
0 may be provided with a cap or seal (not shown) at its tip, if necessary. Further, although the mouth portion 10 is provided in a protruding manner on the outer surface of the container body 1 in the illustrated example, the mouth portion 10 may be formed in a concave shape on the side of the container body 1 so that the mouth portion 10 does not protrude from the outer surface of the container body 1.

The centrifugal separator 8 has a container main body 1 in a rotor 8a.
It is preferable to use a hematocrit centrifuge having grooves 8b in which the The rotation speed of the rotor 8a is preferably 3000 to 15000 rpm.

When blood is collected using the analysis container of the above embodiment, for example, an earlobe, a fingertip, or a heel is punctured to draw blood, the first drop is wiped off, and one end 2a of the hollow part 2 is applied to the next blood drop. , which is collected using capillary action. Then, when the blood sample reaches the indicator line 3 indicating the amount to be collected, it separates from the perforated part.

Thereafter, one end 2a of the hollow part 2 is sealed by melting or using a sealing member 7, and when it is centrifuged in a centrifuge 8, it is separated into a heavy blood cell component 5 and a light plasma or serum component 6 due to the difference in specific gravity. After centrifugation is completed, measure the hematrices if necessary (if this measurement is essential, attach necessary scales on the outer surface of the container body 1 in the longitudinal direction of the hollow part 2). ), the branch hole 4 is faced downward to face the analytical element 11 as shown in the fourth figure. In this case, the positioning of the branch hole 4 and the analytical element 11 can be done by visual inspection if the container body 1 is transparent; A positioning device may also be used.

After the branch hole 4 is made to face the analytical element 11 in this way, the pipette 12 is placed at the other end 2b of the hollow part 2.
(It is preferable that the other end 2b of this hollow part 2 has a form that can be connected to an ordinary pipettor.) and press the push rod 13 as shown by the arrow in Fig. 4 to release plasma or serum. The component 6 is pushed out through the branch hole 4 and applied to the analytical element 11.

FIG. 5 shows a second embodiment of the invention. In this case, branch holes 4, 4', and 4'' are provided that communicate with the outside from three locations in the hollow portion 2 that can hold a blood sample.Among these branch holes 4 to 4'', the middle of the hollow portion 2 is provided. The branch hole 4 in the part contains the plasma or serum component 6 mentioned above.
The branch hole 4' on one end 2a side of the hollow part 2 is for blood injection, and the branch hole 4'' on the other end 2b side is a hole for air injection connected to a pipettor. The branch holes 4', 4'' for air injection and air injection are normally sealed with rubber plugs or simple sealing members (not shown). Therefore, in order to inject a blood sample into the hollow part 2 of this second embodiment, first, one end 2a of the hollow part 2 is sealed with the sealing member 7. Then, the branch hole 4' for blood injection is opened, and the blood is injected directly from there to the indicated line 3 with a syringe.
Next, the branch hole 4' for blood injection is sealed and centrifuged in the same manner as described above to separate the blood cell component 5 and plasma or serum component 6, and the branch hole 4 is faced downward to face the analytical element. At the same time, by connecting a pipettor to the upwardly directed branch hole 4'' for air injection and operating the push rod, plasma or serum components can be pushed out through the branch hole 4.

FIG. 6 shows a third embodiment of the invention. In this case, the other end 2b side of the hollow portion 2, which is capable of holding a blood sample, is bent in the opposite direction to the installation direction of the branch hole 4. This is so that when the branch hole 4 is turned downward when plasma or serum components are taken out, the other end 2b of the hollow part 2 is turned upward, and the pivot can be easily connected from the vertical direction. Note that the other functions are the same as in the first embodiment.

〔Effect of the invention〕

As described above, the present invention provides a transparent container body having a hollow part made of a capillary tube that can hold a blood sample in a penetrating manner, and the amount of the blood sample to be collected from one end of the hollow part on the outer surface of the container body. After collecting the sample in the hollow part, the collecting end is sealed and the blood sample is separated into blood cell components and plasma or serum components in the hollow part when the sample is centrifuged with the sealed side outside. Define a dividing surface that separates the two, and define a branch hole that communicates with the outside from the hollow part on the plasma or serum component side of the dividing surface, and set a branch hole that is perpendicular to the axial direction of the hollow part or on the plasma or serum component side. Since the blood sample is tilted to the side, after a collected blood sample is separated into blood cell components and plasma or serum components by centrifugation, it can be directly applied to the analytical element by simply applying pressure from a predetermined location. Therefore, the operation is extremely simple, and the excellent effect that only plasma or serum components can be extracted accurately and quickly is achieved.

[Brief explanation of drawings]

1 to 4 show a first embodiment of the present invention, in which FIG. 1 is a perspective view of the external appearance, FIG. 2 is a sectional view showing the state after centrifugation of a blood sample, and FIG. 3 is a centrifugal view of the blood sample. A perspective view of the rotor portion of the separator, FIG. 4 is a cross-sectional view showing the action when taking out plasma or serum components, FIG. 5 is a cross-sectional view of the second embodiment, and FIG. 6 is a cross-sectional view of the third embodiment. It is. 1... Container body, 2... Hollow part, 3... Indication line, 4,
4', 4''... Branch hole, 5... Blood cell component, 6... Plasma or serum component, 7... Plasma member.

Claims (1)

[Claims] 1. A transparent container body is provided with a hollow part made of a capillary tube that can hold a blood sample in a penetrating shape, and an indicator line is provided on the outer surface of the container body to indicate the amount of blood sample to be collected from one end of the hollow part, and after collecting the sample in the hollow part, the collecting end is sealed and the blood sample is separated into blood cell components and plasma or serum components in the hollow part when the blood sample is centrifuged with the sealed side outside. A branch hole communicating with the outside from the hollow portion is provided on the plasma or serum component side of the dividing surface at a right angle to the axial direction of the hollow portion or inclined toward the plasma or serum component side. An analytical container featuring: