JP4894566B2 - Blood sample dispensing kit and blood sample dispensing method - Google Patents

Description

  The present invention relates to a blood sample dispensing kit and a blood sample dispensing method.

  Conventionally, clinical laboratory data is used independently by each medical institution. However, it has become increasingly common for patients to visit a plurality of medical institutions and for healthy people to come to the hospital with their health checkup results. Therefore, there is a need to generalize the mutual use of clinical laboratory data.

  In view of the present situation, the clinical laboratory data sharing manual of the Japan Clinical Hygiene Laboratory Association has issued a clinical laboratory data sharing manual (Non-patent Document 1). In this manual, it is obliged to measure accuracy at least four times a year in quality control data in the maintenance of measurement in clinical tests. Further, the manual introduces that (1) a commercially available control sample or (2) a homemade sample is used as the quality control sample (blood sample). From the viewpoint of cost reduction in a medical institution and a difference in reactivity between a commercially-managed sample in a measurement reagent and a completely human-derived blood sample, it is preferable to use (2) a homemade sample.

  By the way, in order to prepare a homemade sample, a special apparatus is required. Prior to the publication of the above manual, the applicant has provided a plasma purification apparatus as shown in FIG. 3 to a medical institution and has contributed to reducing the cost of the medical institution. This contribution is recognized, and the applicant's product is also introduced in the above manual.

  By the way, it is preferable to dispense and store the prepared homemade sample in a small container in order to perform each reference measurement. However, the blood sample may be contaminated or cause an infection accident during the column work.

Medical Examination Vol. 55, No. 11, 2006

  An object of the present invention is to provide a kit and a method for dispensing a blood sample safely and easily.

The present invention is [1] a kit for dispensing a blood sample as a quality control sample ,
The kit includes a blood dispensing unit and a vacuum blood collection tube,
The blood dispensing unit is
A bag for containing a blood sample,
A blood sample dispensing kit comprising a plurality of blood collection tube holders connected directly or indirectly to the bag port;
[2] Furthermore, it comprises a branch pipe having at least two or more branch paths,
The blood collection kit according to [1], wherein the blood collection tube holder is connected to the bag via the branch path;
[3] The blood sample dispensing kit according to [1], wherein the vacuum blood collection tube includes a light-shielding layer in a bottomed container,
[4] A method of dispensing a blood sample as a quality control sample using a blood dispensing kit,
The blood dispensing kit includes a blood dispensing unit and a reduced-pressure blood collection tube,
The blood dispensing unit is
A bag for containing a blood sample,
Comprising a blood collection tube holder connected directly or indirectly to the bag,
(1) storing a blood sample in a bag;
And (2) a blood sample dispensing method comprising the step of connecting the reduced pressure blood collection tube to the blood collection tube holder,
And [5] The blood sample dispensing method according to [4], wherein the blood sample is serum for quality control.

  According to the blood dispensing kit and method of the present invention, an operator can dispense a blood sample safely and easily.

  The present invention takes a kit form including a blood sample dispensing unit A and a plurality of reduced-pressure blood collection tubes B. That is, the blood sample dispensing unit A is used to achieve safe and easy dispensing of a blood sample into a plurality of reduced-pressure blood collection tubes B.

In the present invention, "blood sample as a quality control sample"
(A) Blood sample purchased commercially (B) Serum sample separated and purified from residual blood after testing (pooled serum)
(C) Whole blood sample (blood test sample) collected from volunteers with informed consent
(D) Serum sample (serum) separated and purified from (C) above
Say. The “homemade sample” refers to the samples (B) to (D) among the blood samples. Furthermore, when the blood sample is serum, it is called quality control serum.

  Hereinafter, the present invention will be described with reference to the drawings.

  FIG. 1 shows a blood sample dispensing unit A of the present invention. The blood sample dispensing unit A includes a bag 1 for storing a blood sample, and a blood collection tube holder 2 connected directly or indirectly to the bag 1.

  The bag in the present invention refers to a container that is manufactured by welding from a film and can collect a blood sample, and includes at least one port 11. The bag 1 is not particularly limited as long as it is approved for medical use. However, it is preferable that the capacity be enough to accommodate the blood sample. Specifically, the bag 1 preferably has a capacity of about 300 to 5000 ml, preferably about 500 to 3000 ml. As the bag 1, it is desirable to use Nipro Alime Bag (registered trademark) from the viewpoint that it has a capacity capable of sufficiently storing a blood sample and the film constituting the bag 1 has sufficient strength.

  A blood collection tube holder 2 is connected to the bag 1 directly or indirectly. In the present invention, the blood collection tube holder is a device for stably piercing a rubber stopper of a decompression blood collection tube B, which will be described later, and for taking a blood sample stored in the bag 1 into the decompression blood collection tube B. Means a device. The said blood collection tube holder 2 should just employ | adopt a commercially available thing, and since it does not specifically limit, it abbreviate | omits for details.

  In the case where the blood collection tube holder 2 is directly connected to the bag 1, for example, a mode in which the blood collection tube holder 2 is processed so that the blood collection tube holder 2 can be directly connected to the port 11 of the bag 1 can be mentioned. However, from the viewpoint that the operability is improved and the commercially available blood collection tube holder 2 can be used as it is, for example, an embodiment in which the tube 3 is indirectly connected as shown in FIG. 1 is preferable. Of course, these tubes 3 may be provided with means for controlling the flow rate, such as a roller clamp (not shown).

  The material of the tube 3 is not particularly limited as long as it is a material suitable for medical use. Examples include polyvinyl chloride, polytetrafluoroethylene and poly (ethylene-vinyl alcohol) copolymers.

  Moreover, as an aspect in the case of indirectly connecting the blood collection tube holder 2 to the bag 1, as shown in FIG. 1, branch pipes 41 and 42 may be further provided. In the present invention, the branch pipe refers to an instrument for diverting a blood sample stored in the bag 1. The number of flow paths that branch in the branch pipes 41 and 42 (referred to as “branch paths” in the present invention) is not particularly limited as long as it is two or more, but has two branch paths used in a bag system in the medical field. It is sufficient to use a branch pipe. Specifically, a Y-shaped tube, a T-shaped tube, a three-way stopcock, and the like correspond to this. Of course, these branch pipes 41 and 42 are not particularly limited as long as they are approved for medical use.

  Of course, the number of branch pipes 41 and 42 is not limited to one, and the branch pipe 41 and 42 may be further branched by using a three-way cock 42 as the second branch pipe as shown in FIG. The blood sample dispensing unit A shown in FIG. 1 shows only one embodiment in which the number of terminal branches is four. Of course, the final number of branches at the end can also be appropriately set by those skilled in the art. The number should just be about 1-6 considering the work efficiency of dispensing.

  A mode of connecting the branch pipes 41 and 42 to the bag 1 can be appropriately selected by those skilled in the art, and is not particularly limited. For example, the branch pipes 41 and 42 can be directly connected to the bag 1 by a method such as welding. However, it is preferable to connect indirectly using the tube 3 from the viewpoint of improving the operability in the dispensing operation.

  Here, when a three-way cock having a Luer taper connection structure is adopted as an aspect of the branch pipes 41 and 42, the blood collection tube holder 2 also punctures a so-called human blood vessel from the viewpoint of easy connection with the three-way cock. It is preferable that the portion connecting the metal needles has a luer taper connection structure. As a result, as shown in FIG. 1, the blood collection tube holder 2 can be easily connected directly to the branch pipe (three-way stopcock) 42 by the Luer taper structure.

  In general, the blood collection tube holder 2 is usually connected to a tip thereof with a metal needle for puncturing a human blood vessel. It does not exist in the past. That is, since the blood collection tube holder 2 is usually an instrument used for collecting blood from a human using a reduced pressure blood collection tube, even those skilled in the art can easily conceive the present invention. I can't.

  Furthermore, the connection of the blood collection tube holder 2 directly to the three-way cock 42 that is one embodiment of the branch pipe is not naturally performed in the recent medical instrument industry. Also in this regard, it can be said that those skilled in the art cannot easily conceive the present invention.

  Moreover, although FIG. 1 has shown the aspect connected directly to the branch pipe (three-way cock) 42, of course, the aspect connected indirectly via a tube may be sufficient. This is the same reasoning as when the bag 1 and the branch pipes 41 and 42 are connected. When indirectly connecting using the tube 3, although not shown in figure, the aspect which provides the instrument which has a luer taper structure in the terminal of the tube 3, and connects the blood-collecting-tube holder 2 is mentioned, for example.

  The bag 1 and the blood collection tube holder 2 of the blood sample dispensing unit A described above may be provided to the medical institution in an assembled state or may be provided to the medical institution as an assembly set.

  The blood sample dispensing kit of the present invention further includes a reduced pressure blood collection tube B. In the present invention, the reduced-pressure blood collection tube refers to one having a lid member partially or entirely made of rubber, and a cylindrical bottomed container whose inside is in a reduced pressure state. The decompressed blood collection tube is referred to as a vacuum blood collection tube in the medical industry. The lid member in the vacuum blood collection tube B includes a rubber plug type and a film type as disclosed in Japanese Patent Laid-Open No. 06-189944, but the vacuum blood collection tube in the present invention is limited to these embodiments. Is not to be done.

  In addition, the reduced-pressure blood collection tube B preferably includes a light-shielding layer around the bottomed container in order to prevent photolysis of substances present in a blood sample such as bilirubin. As an aspect provided with a light shielding layer, what laminated the light shielding film on the surface of the conventional transparent bottomed container, or the thing manufactured with the composition which mix | blended the pigment which has a light shielding effect to a raw material is mentioned.

  The light-shielding film can be appropriately selected by those skilled in the art and is not particularly limited. For example, an aluminum vapor-deposited film or a material such as a polyvinyl chloride resin, a polyethylene resin, or a polyester resin is used. And a composition comprising a pigment having a light shielding effect. These resins may be copolymers with other monomers such as vinyl acetate, propylene, alkyl vinyl ether, ethyl acrylate and methyl methacrylate.

  Examples of the pigment include inorganic pigments such as carbon black and titanium black, and organic pigments such as aniline black, but the present invention is not limited thereto.

  The present invention also extends to a blood sample dispensing method using the above blood sample collection kit. The blood sample dispensing method of the present invention includes (1) storing a blood sample in a bag, and (2) connecting a reduced-pressure blood collection tube to a blood collection tube holder.

  The above “(1) step of storing the blood sample in the bag” simply needs to store the blood sample in the bag 1. The step is preferably performed aseptically. For example, when a serum sample (pooled serum) separated and purified from the residual blood after the test (B) is stored in the bag 1 as a blood sample, a plasma purification apparatus provided by the applicant as shown in FIG. 3 is used. As an example of a container for collection when preparing a homemade sample, an embodiment using the bag 1 of the present invention can be mentioned. Of course, if the amount of serum sample to be purified (pooled serum) is large, a plurality of bags 1 may be connected accordingly.

  In addition, the above “(2) step of connecting the reduced pressure blood collection tube to the blood collection tube holder” simply connects the reduced pressure blood collection tube to the blood collection tube holder and causes the blood dispensing unit A and the reduced pressure blood collection tube B to communicate. The work is not burdened by the worker. For example, in the case of the embodiment shown in FIG. 1, since four blood collection tube holders 2 are provided, blood samples can be dispensed simultaneously into the four reduced pressure blood collection tubes B. FIG. 2 is a diagram showing the usage mode. And this operation | work is repeated and a blood sample is dispensed to the several vacuum blood collection tube B. FIG.

  According to the present invention, since the reference sample in clinical laboratory data management can be handled aseptically, the reliability of clinical laboratory data in the medical field is improved. The present invention will be employed in many medical institutions in the future.

It is a figure which shows one embodiment of the blood sample dispensing unit of this invention. It is a figure which shows the usage condition of the blood sample dispensing unit shown in FIG. It is a circuit diagram of a serum purification apparatus provided by the present applicant.

Explanation of symbols

1 Bag 11 Port 2 Blood collection tube holder 3 Tube 41 Branch pipe (Y-shaped pipe)
42 Branch pipe (three-way stopcock)
B Vacuum collection tube 51 Stock solution tank 52 Prefilter 53 Pump 541 Negative pressure system 542 Positive pressure system 55 Serum filter 56 Chamber 57 Roller clamp

Claims (5)

A kit for dispensing a blood sample as a quality control sample ,
The kit includes a blood dispensing unit and a vacuum blood collection tube,
The blood dispensing unit is
A bag for containing a blood sample,
A blood sample dispensing kit comprising a plurality of blood collection tube holders connected directly or indirectly to the bag . And a branch pipe having at least two or more branch paths,
The blood dispensing kit according to claim 1, wherein the blood collection tube holder is connected to the bag via the branch path. The blood sample dispensing kit according to claim 1, wherein the vacuum blood collection tube comprises a light-shielding layer in a bottomed container. A method of dispensing a blood sample as a quality control sample using a blood dispensing kit,
The blood dispensing kit includes a blood dispensing unit and a reduced-pressure blood collection tube,
The blood dispensing unit is
A bag for containing a blood sample,
Comprising a blood collection tube holder connected directly or indirectly to the bag,
(1) storing a blood sample in a bag;
And (2) A blood sample dispensing method including the step of connecting the reduced pressure blood collection tube to the blood collection tube holder. The blood sample dispensing method according to claim 4, wherein the blood sample as the quality control sample is serum for quality control.

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