JP2000249699A - Blood-holding tool - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood-holding tool with a blood-holding part and a humidifying means which can prevent blood from being dry by humidifying the blood-holding part by the humidifying means. SOLUTION: A glass filter 5 and a filter paper 2 are arranged in the vicinity of an inner opening of a bottomed cylindrical container 1. A hydrophilic polymer gel 6 such as gelatin gel or the like is disposed to the bottom of the bottomed cylindrical container 1. When a whole blood 7 is supplied, blood corpuscles are separated by the glass filter 5 and only a blood plasma is held by the filter paper 2. The blood plasma is prevented from drying owing to the steam generated from the hydrophilic polymer gel 6.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood holding device for holding blood for a clinical test or the like.

[0002]

2. Description of the Related Art Recently, a remote clinical test system has been proposed and partially implemented. This system is a system in which a patient or the like undergoing a test collects urine or blood at home or the like, mails it to a clinical laboratory such as a hospital, and tests it according to each diagnostic item. . This test system has the advantage that a subject can receive a test without going to a test institution, and is rapidly spreading. In this test system, as a means for mailing blood or the like, a method of impregnating a card with blood or the like, placing the card in an envelope, and mailing the card has been proposed (Japanese Unexamined Patent Application Publication No.
-104226).

[0003] However, when the blood impregnated in the card is mailed and tested, it may not be possible to perform an accurate test depending on the test items.

[0004]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a blood holding device that can perform an accurate test even when blood is mailed and tested.

[0005]

In order to achieve the above object, a blood holding device of the present invention comprises a blood holding portion and a humidifying means, wherein the blood holding portion is humidified by the humidifying means. Have.

[0006] The present inventors have examined in detail the cause of the inability to perform an accurate test when blood is mailed by impregnating the card and finding out that the cause is that the blood dries. By mail, it takes at least a day from blood collection to testing, and may take several days in remote locations. When the card is impregnated with blood and held for a long time, water in the blood evaporates, which may result in an inaccurate test, and particularly a blood glucose level (Glu).
And in glutamate-pyruvate transaminase (GPT), the reliability is compromised. The present invention
Based on this finding, the blood holding device of the present invention can keep blood in a wet state while preventing drying by the above-described configuration. Therefore, by using the blood holding device of the present invention, even if it is necessary to hold blood for a long time as in the case of mailing, it is possible to perform the test accurately. In addition,
The blood holding device of the present invention can be preferably used for blood transport in a remote clinical test system, but its use is not limited, and can be used for ordinary clinical tests.

The blood held by the blood holding device of the present invention is not particularly limited, and may be any of whole blood, blood cells, serum and plasma.

In the blood holding device of the present invention, the humidifying means is preferably a member containing water, and the blood holding portion is humidified by the evaporation of water from the member. The water-containing member is not particularly limited, and may be a porous member such as a sponge. However, a hydrophilic polymer gel which does not leak water is preferable. The hydrophilic polymer gel is not particularly limited, and examples thereof include a cellulose gel, a gelatin gel, an agarose gel, and a polyacrylamide gel. These hydrophilic polymer gels
They may be used alone or in combination of two or more.

[0009] In the blood holding device of the present invention, the relative humidity of the blood holding portion is usually in the range of 80 to 100%, preferably in the range of 90 to 100%.

When the test object is serum or plasma, the blood holding device of the present invention further has a blood cell separating portion, which is adjacent to the blood holding portion, and the supplied blood passes through the blood cell separating portion. It is preferable that serum or plasma be held in the blood holding part by being introduced into the blood holding part. With this configuration, the blood cells are automatically separated by the supply of the blood, so that the labor of the blood cell separation operation at the inspection institution is omitted, and the test efficiency is improved.

[0011] In the blood holding device of the present invention, the form of the blood holding portion is not particularly limited. For example, the blood holding portion may be formed of a porous member or the blood holding portion may be formed of a capillary tube. Any of them may be used.

[0012]

FIG. 1 shows an example of the blood holding device of the present invention. FIG. 1A is a top view of FIG.
(B) is a cross-sectional view in the II direction of the top view.

As shown in the drawing, the blood holding tool has a configuration in which a blood cell separating material 5, a blood holding material 2, and a humidifying agent 6 are arranged inside a bottomed cylindrical container 1. The blood cell separating material 5 and the blood holding material 2 are both in the shape of a circular sheet and are laminated. The shapes of the blood cell separation material 5 and the blood holding material 2 may be square sheet shapes. The laminated body (2, 5) is in a state where the blood cell separating material 5 is located outside, and the edge of the laminated body (2, 5) is embedded in the inner peripheral wall of the bottomed cylindrical container 1. And is disposed near the upper opening inside the bottomed cylindrical container 1. Further, the humidifier 6 is arranged at the bottom inside the bottomed cylindrical container 1. And the said humidifier 6 and the said laminated body (2,5)
A partition portion 3 is formed between the two, and a plurality of ventilation holes 4 are formed in the partition portion 3. In the figure, reference numeral 7 denotes the supplied whole blood.

As the blood cell separating material 5, a porous material is usually used, and for example, a non-fibrous microporous membrane or a fibrous microporous membrane can be used. Examples of the non-fibrous microporous membrane include brushes made of cellulose esters described in JP-B-53-21677, US Pat. Microporous membranes of polymers, polyamides such as 6-nylon and 6,6-nylon, polyethylene and polypropylene, microporous membranes composed of polysulfone described in JP-A-62-27006, microporous membranes composed of nitrocellulose Porous membrane, having continuous voids in which small polymer particles, glass particles, diatomaceous earth, etc. described in JP-B-53-21677, JP-A-55-90859, etc. are bonded with a hydrophilic or non-water-absorbing polymer. A porous layer or the like can be used. As the fibrous microporous membrane, for example,
Filter paper, nonwoven fabric, woven fabric (for example, plain woven fabric), knitted fabric (for example, tricot knit), glass fiber filter paper (glass filter), and the like can be used. The pore diameter of these porous materials is not particularly limited as long as they do not allow blood cells to pass through, and is usually in the range of 0.2 to 60 μm, preferably 1 to 2 μm.
The range is 0 μm. The thickness of the porous material is usually in the range of 10 to 200 μm, preferably 30 to 200 μm.
The range is 150 μm.

As the blood holding material 2, an absorbent member is usually used, for example, a porous film formed of a resin such as filter paper or a water-absorbing polymer is used. The blood retaining material 2 may contain a preservative such as sodium azide, benzoic acid, and sorbic acid, a buffer such as citric acid and phosphoric acid, and a hydrophilic polymer and a hydrophobic polymer. . When whole blood is retained, an anticoagulant such as heparin may be contained.

As the humidifier 7, a sponge material impregnated with water or the above-mentioned hydrophilic polymer gel can be used, but a hydrophilic polymer gel is preferable. The water content of the hydrophilic polymer gel can be expressed as a gel concentration. Gel concentration is appropriately determined in consideration of the size and strength of the gel,
Usually, it is in the range of 1 to 50% by weight, preferably 5 to 50% by weight.
It is in the range of 30% by weight. As the type of the gel, a cellulose gel, a gelatin gel, an agarose gel, and a polyacrylamide gel are preferable. When a gelatin gel or the like is used, it is preferable to include a preservative.

The material for forming the bottomed cylindrical container 1 is not particularly limited, but usually, a vinyl chloride resin, an acrylic resin, a polyester resin, a polystyrene resin, or the like is used. Among them, polystyrene, which is excellent in strength and flexibility, is preferable in consideration of impact and vibration during mailing.

The size of the blood holding device is not particularly limited, but is usually 2 to 30 m in height in consideration of mailing.
m, outer diameter 5-50 mm, inner diameter 2-20 mm, partition 3
The thickness is in the range of 0.1 to 2 mm, and preferably 5
~ 20mm, outer diameter 10 ~ 30mm, inner diameter 5 ~ 10mm,
The thickness of the partition 3 is in the range of 0.2 to 1 mm. The ventilation holes of the partition part 3 usually have an average pore diameter of 0.1 to 5 mm,
The number of holes is ² to 500 / cm ² , preferably the average pore diameter is 0.5 to 2 mm, and the number of holes is 10 to 100 / cm ^2.
It is. In the blood holding device having the size in the above range, the maximum diameter of the blood cell separating material 5 is usually in a range of 3 to 25 mm, preferably in a range of 7 to 15 mm, and the maximum diameter of the blood holding material 2 is Usually, it is in the range of 3 to 25 mm, preferably in the range of 7 to 15 mm, and the size of the humidifier 6 is usually 3 to 25 mm in diameter and 0 mm in height when its shape is substantially cylindrical. 0.5 to 5 mm, preferably 7 to 15 mm in diameter and 1 to 3 mm in height.
For a blood holding device of such a size, about 0.01
~ 0.1 ml of blood can be retained for about 3-7 days.

As shown in the figure, when the whole blood 7 is supplied to the blood holding device of this example, the blood cells are first separated when passing through the blood cell separating material 5, and the plasma or serum components are introduced into the blood holding material 2, It is held here. And from the humidifier 6
Since water vapor is generated and passes through the ventilation holes 4 of the partition 3 and reaches the blood holding material 2, drying of plasma and serum components is prevented. And if you want to do an inspection,
The blood holding material is taken out using tweezers or a dedicated separating device, and plasma or serum components are extracted therefrom, and a predetermined test is performed.

Although this example has the blood cell separating material 5, it is not necessary to dispose the blood cell separating material 5 when whole blood is to be tested (for example, hemoglobin in blood cells). In this case, the whole blood is held by the blood holding material 2, and the whole blood is extracted in the test.

In this example, the humidifier is arranged in advance, but the present invention is not limited to this, and the humidifier may be arranged after blood is supplied. The same applies to the following examples.

Next, FIG. 2 shows another example of the blood holding device of the present invention. FIG. 2A is a top view, and FIG. 2B is a cross-sectional view in the II-II direction of the top view.

As shown in the figure, the blood holding device is provided with a capillary tube 8 as a blood holding material below a funnel-shaped member 13.
Is inserted. A blood cell separating material 12 is disposed inside the funnel-shaped member 13 and a capillary tube 8 is provided.
A humidifier 9 is arranged at a lower part of the, and an air vent hole 10 is formed at an upper part thereof. In FIG. 2, 7 indicates supplied whole blood, and 11 indicates serum or plasma.

As the blood cell separating material 12, the above-mentioned glass filter or the like can be used, and the pore size is the same as that described above. Further, the size is appropriately determined depending on the size of the funnel-shaped member 13 and the like.

The material for forming the capillary tube 8 is usually glass, but may be other resin such as polystyrene resin, vinyl chloride resin and acrylic resin. The size of the capillary tube 8 is generally 10 to 10 in total length.
0mm, inner diameter 0.05-5mm, outer diameter 0.5-10mm
Preferably, the total length is 30 to 50 mm, the inner diameter is 0.0
5 to 2 mm, outer diameter 0.5 to 5 mm.

The material for forming the funnel-shaped member 13 is usually
Examples include vinyl chloride resin, acrylic resin, and polystyrene resin. The size of the funnel-shaped member 13 is usually a maximum diameter of 3 to 50 mm, an inner diameter of a portion into which the capillary tube 8 is fitted, 0.5 to 10 mm, an overall height of 1 to 50 mm, and a diameter of the air vent hole 10 of 0.01 to 5 mm, preferably
The maximum diameter is 3 to 5 mm, the inner diameter of the portion into which the capillary tube 8 is fitted is 0.5 to 5 mm, the overall height is 1 to 5 mm, and the diameter of the air vent hole 10 is 0.05 to 2 mm.

As the humidifier 9, the above-mentioned hydrophilic polymer gel can be used. The gel concentration is usually 1 to 50% by weight, preferably 5 to 30% by weight.
It is. The size of the humidifier 9 is appropriately determined depending on the size of the capillary tube 8 and the like, but is usually 0.05 to 5 mm in diameter and 1 to 10 mm in height, preferably 0.05 to 2 mm in diameter, The height is 1 to 5 mm.

As shown in the figure, when the whole blood 7 is supplied to the blood holding device of this embodiment, the whole blood is introduced into the capillary tube 8 through the blood cell separating material 12 by capillary action. Since blood cells are separated when passing through the blood cell separating material 12, serum or plasma is introduced into the capillary tube 8. Then, since water vapor is generated from the humidifier 9, the inside of the capillary tube 8 can be maintained in a wet state, and the drying of plasma and serum components is prevented. And
When performing the test, the funnel-shaped member is removed, or the capillary tube 8 is cut with an ampoule cutter or the like, and the serum or plasma components therein are taken out and a predetermined test is performed.

Although this example has the blood cell separating material 12, the blood cell separating material 12 need not be disposed when blood cells are to be tested or when whole blood is to be tested. In this case, whole blood is held in the capillary tube 8, and the whole blood is taken out in the examination.

[0030]

Next, examples will be described together with comparative examples.

Example 1 A blood holding device shown in FIG. 1 was prepared, and plasma was preserved using the device. After that, each test item was tested.

The blood holding device is made of polystyrene resin, and has a size of 20 mm in height, 30 mm in outer diameter, 10 mm in inner diameter, and 0.5 mm in thickness of the partition 3. As the blood holding material 2, a circular filter paper having a thickness of 340 μm and a diameter of 15 mm (manufactured by Whatman, product number: 3MMch)
r) was used. As the blood cell separating material 5, a circular glass filter (manufactured by Germanic Co., product number: Cyt) having an average pore diameter of 0.5 μm, a thickness of 2000 μm, and a diameter of 15 mm is used.
oSep1662) was used. The ventilation holes of the partition 3 have an average hole diameter of 1 mm and a hole number ratio of 30 holes / cm ² .
In addition, as a humidifier, an agarose gel having a gel concentration of 5% by weight was prepared, and was used in the form of a column having a diameter of 10 mm and a height of 5 mm.

[0033] Whole blood collected from a healthy adult male is supplied to the blood holding device, and plasma (10
0 μl), 0 h, 24 h and 96 h,
Stored at room temperature of about 25 ° C. After storage, the filter paper 2 and the glass filter 5 were taken out with tweezers, and after removing the glass filter 5, 300 μl of physiological saline was added to the filter paper 2 to extract plasma. Then, for the plasma samples at each storage time, various test items were tested by a conventional method using a blood measurement device (manufactured by Hitachi, Ltd., type 7070).
The results are shown in Table 1 below. The values in Table 1 are not actual measured values, but are relative values when the measured value at a storage time of 0 hour is set to 100, and the same applies to Table 2 below. In addition,
The inspection items and inspection methods are as follows.

(Test Items) GLU: blood glucose level, enzymatic method ALP: alkaline phosphatase, JSCC method ALB: albumin, BCG method AMY: amylase, immunoinhibition method GOT: glutamic acid-oxaloacetic transaminase, JSCC method GPT: glutamate-pyruvate Transaminase, IFCC method GGT: γ-glutamyl transpeptidase (γ-G
TP), JSCC method CPK: creatine phosphokinase, JSCC method LDH2H: lactate dehydrogenase, JSCC method T-CHO: total cholesterol, cholesterol oxidase method HDL-CHO: HDL cholesterol, direct method TG: triglyceride (neutral fat) , Enzymatic method BUN: serum urea nitrogen, urease method TP: total protein, pyrogallol red / molybdenum complex coloring method CRE: creatinine, HPLC method

(Comparative Example 1) The same storage test as in Example 1 was carried out using the same blood holding tool as in Example 1 except that no humectant was used, and the same test items as in Example 1 were examined. The results are shown in Table 2 below.

[0036]

(Example 1) Storage time inspection items 0 hours 24 hours 96 hours GLU 100 98 98 ALP 100 104 103 ALB 100 100 106 AMY 100 100 100 100 GOT 100 118 91 GPT 100 105 105 105 GGT 100 100 100 GPK 100 98 97 LDH2H 100 99 98 T-CHO 100 99 99 102 HDL-CHO 100 101 94 TG 100 109 109 BUN 100 100 107 TP 100 100 103 CRE 100 109 118

[0037]

(Comparative Example 1) Storage time inspection items 0 hours 24 hours 96 hours GLU 100 89 61 ALP 100 104 83 ALB 100 121 114 114 AMY 100 117 108 GOT 100 122 100 GPT 100 107 50 GGT 100 124 88 GPK 100 106 69 LDH2H 100 106 90 T-CHO 100 125 116 HDL-CHO 100 118 109 TG 100 130 123 BUN 100 107 107 TP 100 121 117 CRE 100 110 120

As can be seen from Table 1, in the blood holding device of the example, the measured value of each test item hardly changed with time. On the other hand, in the comparative example, as can be seen from Table 2, a large temporal change was observed in GLU, CPK, GPT, and the like.

Further, a blood holding device using the capillary tube shown in FIG. 2 was prepared, and each blood test was performed in the same manner as in Example 1. As a result, there was almost no change in measured values with time. Was.

[0040]

As described above, the blood holding device of the present invention has a structure in which the blood holding portion and the humidifying means are provided and the blood holding portion is humidified by the humidifying means. Drying of the blood of the part is prevented. By using the blood holding device of the present invention, which can hold blood in a state where drying is prevented in this way, even if blood is held for a long period of time, it is possible to perform an accurate test. Therefore, if the blood holding device of the present invention is used in a remote clinical test system that requires mailing of blood, a blood test can be performed accurately.

[Brief description of the drawings]

FIG. 1 is a view showing an example of a blood holding device of the present invention,
FIG. 1A is a top view, and FIG. 1B is a cross-sectional view in the II direction of the top view.

FIG. 2 is a view showing another example of the blood holding device of the present invention, FIG. 2 (A) is a top view thereof, and FIG.
It is II-II direction sectional drawing of the said top view.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Cylindrical container 2 Blood holding material 3 Partition part 4 Vent hole 5, 12 Blood cell separation material 6, 9 Humidifier 7 Whole blood 8 Capillary tube 10 Air vent 11 Serum or plasma 13 Funnel-shaped member

 ────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Takanori Uchigaki 57-term, Higashi-kujo, Nishi-Akita-cho, Minami-ku, Kyoto-shi, Kyoto F-term (reference) 2G045 AA01 BA08 BA10 BB06 BB60 CA25 CA26 HA06 HA14 HB13

Claims (8)

[Claims] 1. A blood holding device comprising a blood holding unit and a humidifying unit, wherein the blood holding unit is humidified by the humidifying unit. 2. The humidifying means is a member containing water,
The blood holding device according to claim 1, wherein the blood holding portion is humidified by evaporation of water from the member. 3. The blood holding device according to claim 2, wherein the member containing water is a hydrophilic polymer gel. 4. The method according to claim 1, wherein the hydrophilic polymer gel is a cellulose gel,
4. The blood holding device according to claim 3, which is at least one hydrophilic polymer gel selected from the group consisting of a gelatin gel, an agarose gel, and a polyacrylamide gel. 5. The blood holding section has a relative humidity of 80 to 100.
The blood holding device according to any one of claims 1 to 4, which is in the range of%. 6. The blood holding part further comprising a blood cell separating part, which is adjacent to the blood holding part, and supplied blood is introduced into the blood holding part through the blood cell separating part. The blood holding device according to any one of claims 1 to 5, wherein the blood or serum is held in the blood holding device. 7. The blood holding device according to claim 1, wherein the blood holding portion is formed of a porous material. 8. The blood holding device according to claim 1, wherein the blood holding portion is a capillary tube.