Solution and method for delivering or preserving trace blood

By dilute the trace blood more than 8 times, and the diluted solution containing buffer and salt is used, the problem of glycating the blood sample during transportation or preservation is used to ensure the measurement accuracy of the GA value.

CN119365777APending Publication Date: 2025-01-24PROVIGATE KK
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Patent Information

Application Number
CN202380046618.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-11-30
Filing Date
2023-11-27
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

When transporting or preserving trace amounts of blood, albumin reacts with glucose present in the blood, resulting in an increase in the saccharification degree of glycated albumin, affecting the accuracy of GA value determination.

Method used

By dilution of blood samples greater than 8 times, the diluted solution containing buffer and salt is used to reduce the frequency of physical contact between albumin and glucose, and inhibit the speed of glycation.

Benefits of technology

During the transportation or saving process, the glycosylin speed of glycated albumin is effectively suppressed, the determination accuracy of the GA value is ensured, and the measurement caused by hemolysis or other factors is inaccurate.

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Abstract

According to one embodiment of the present invention, a solution for transporting or storing a blood sample can be provided. The blood sample can be a trace blood sample. In several embodiments, the solution may contain a buffer and a salt as active ingredients. The solution may be configured so as to dilute the blood at a dilution rate of 10 times or more.
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Description

Technical Field

[0001] The present invention relates to solutions and methods for transporting or preserving minute quantities of blood. Background Art

[0002] In a blood test, various biomarkers contained in the blood are measured by various methods. One example is glycated albumin in the blood. Glycated albumin is a glycated product of albumin. Albumin is a protein that exists in large quantities in the body and has a high binding rate with glucose. It is said that the glycation degree (GA value or GA%) of glycated albumin (GA) represents the average value of blood sugar levels in the last two weeks. Therefore, the GA value has attracted attention in recent years as an indicator used in blood sugar control / management.

[0003] Ideally, the GA value is measured at a higher frequency than that of a conventional blood test. Therefore, an effective method is to perform a transport test instead of a test in a hospital. Specifically, the user collects a small amount of blood such as fingertip blood and sends it to a test institution by a transport method such as mail. The test institution may have a measuring device that can perform tests efficiently and accurately, and may provide the test results to the user and related institutions.

[0004] Glucose or other components in whole blood may react with albumin during transportation or storage and affect the final actual GA value or even the determination of the GA value. Summary of the invention

[0005] In some embodiments of the present invention, a solution for transporting or storing a blood sample is provided. In some embodiments, the blood sample can be a trace amount of blood sample. In some embodiments, the solution can contain a buffer and a salt as an active ingredient. The solution can be formed in a manner that dilutes the blood at a dilution rate of more than 8 times.

[0006] Further aspects and advantages of the present invention will be readily apparent to those skilled in the art from the following detailed description which merely illustrates exemplary embodiments of the present invention. As will be appreciated, the present invention may be in other different embodiments, some of the details of which may be modified in various obvious aspects without departing from the present invention. Therefore, the drawings and descriptions are to be regarded as illustrative in nature and not as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 This is a graph showing the time-dependent change of GA value at different dilution rates in one example.

[0008] Figure 2 This is a graph showing the change in GA value over time in two examples.

[0009] Figure 3A schematic diagram illustrating the steps of using a mailing kit containing a diluent according to one embodiment.

[0010] Figure 4 A schematic diagram illustrating the steps of using a mailing kit containing a diluent according to one embodiment. DETAILED DESCRIPTION

[0011] <Trace amounts of blood>

[0012] The blood sample can be provided by various methods. In some embodiments, the blood sample can be capillary blood. In some embodiments, the blood sample can be collected from a vein or artery of a living body. In some embodiments, the blood sample can be collected by puncture. It can be collected from droplets (capillary blood) generated on the skin by puncturing the fingertips, earlobes, soles of feet, arms, abdomen, etc. In some embodiments, the blood sample can be collected by the subject himself. In some embodiments, it can be collected by a doctor, a nurse, or a clinical laboratory technician. In some embodiments, the blood sample can be collected near the inspection device (for example, a clinic where the inspection device is installed, etc.).

[0013] In some embodiments, the blood sample collected from the subject may be a trace amount of blood. The trace amount of blood may have a volume of a droplet of a trace amount of blood (capillary blood) generated on the skin by puncture.

[0014] The volume of the fingertip blood is generally between 0.5 μL and 20 μL. In some embodiments, the volume of the fingertip blood is 10 μL. A prescribed volume of blood may be collected.

[0015] The volume can be the same as or greater than 0.1 μL, 0.2 μL, 0.3 μL, 0.4 μL, 0.5 μL, 0.6 μL, 0.7 μL, 0.8 μL, 0.9 μL, 1.0 μL, 1.1 μL, 1.2 μL, 1.3 μL, 1.4 μL, 1.5 μL, 1.6 μL, 1.7 μL, 1.8 μL, 1.9 μL, 2.0 μL, etc.

[0016] The volume can be the same as or smaller than 1.0 μL, 1.5 μL, 2 μL, 3 μL, 4 μL, 5 μL, 6 μL, 7 μL, 8 μL, 9 μL, 10 μL, 15 μL, etc.

[0017] In some embodiments, the blood sample mixed with the diluent may be whole blood. In some embodiments, the blood sample mixed with the diluent may be plasma or serum.

[0018] <Dilution ratio>

[0019] The description of "dilution rate" or "N×" used in this specification means (V0+V1) / V0 when using a dilution solution of volume V1 relative to a collected blood volume V0. For example, when 10 μL of a transport solution or a storage solution is prepared by mixing 9 μL of a dilution solution with 1 μL of collected blood, the dilution rate is "10 times" or "10×".

[0020] The inventors have found that during transportation or storage, albumin reacts with glucose present in the blood and becomes saccharified, and the measured value may vary. It is generally believed that the rate of saccharification increases with the increase in the frequency of physical contact between albumin and glucose. Dilution of the blood sample helps to reduce this frequency and inhibit the rate of saccharification. Through sufficient dilution, the GA value can be obtained within the required accuracy within the actual range of transportation time (e.g., several hours, 2 days, several days, 1 week) and temperature (e.g., room temperature, normal temperature, etc.). In some embodiments, such a sufficient dilution rate can be used. When the dilution rate is too low, that is, when a sufficient dilution rate is not used, the GA value varies during transportation, and the GA value of the object cannot be obtained with good accuracy.

[0021] The dilution ratio may be the same as or greater than 5×, 6×, 7×, 8×, 9×, 10×, etc. In some embodiments, the dilution ratio may be greater than 5×. In some embodiments, the dilution ratio may be greater than 8×. In some embodiments, the dilution ratio may be greater than 10×.

[0022] When the dilution rate is too high, that is, when the albumin concentration is too low, the measurement cannot be performed. At least the measurement method and the measurement device have a concentration limit. The concentration of albumin in the mixed solution needs to be greater than that. The amount of blood collected from the subject is sometimes small. The concentration must be within a range that can be measured at least in principle or in practice.

[0023] The dilution ratio may be the same as or less than 10×, 15×, 20×, 25×, 30×, 40×, 50×, 60×, 70×, 80×, 90×, 100×, etc. In some embodiments, the dilution ratio may be 100× or less. In some embodiments, the dilution ratio may be 90× or less. In some embodiments, the dilution ratio may be 80× or less. In some embodiments, the dilution ratio may be 50× or less. In some embodiments, the dilution ratio may be 20× or less.

[0024] In some embodiments, the dilution ratio may be between 5× and 100×. In some embodiments, the dilution ratio may be between 8× and 100×. In some embodiments, the dilution ratio may be between 9× and 100×. In some embodiments, the dilution ratio may be between 10× and 100×.

[0025] <Buffer>

[0026] In some embodiments, the solution may contain a buffer. In some embodiments, the buffer may be selected from the group consisting of HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), sodium acetate and PBS (phosphate buffered saline).

[0027] <Salt>

[0028] In some embodiments, the solution may contain a salt. The salt may be, for example, but not limited to, NaCl, KCl, etc. In some embodiments, the salt may be NaCl.

[0029] In some embodiments, the solution can be adjusted to be isotonic to the blood cell components. Thus, hemolysis can be suppressed. Hemolysis usually has no effect on HPLC measurement. However, when components such as hemoglobin that appear due to hemolysis are heated or denatured or modified over time, these sometimes affect HPLC measurement. Alternatively, hemolysis can affect optical measurements such as absorbance measurement. Therefore, suppressing hemolysis during transportation or storage reduces the risk of being unable to measure or causing inaccurate measurements.

[0030] <GA measurement>

[0031] In the present invention, the method for measuring GA is not limited. In some embodiments, GA value can be measured by HPLC. In some embodiments, GA value can be measured by enzymatic method or the like.

[0032] The absorbance measuring device using the enzymatic method is usually low-cost and does not require a large space. Furthermore, commercially available reagents can be used, and there is no need to set conditions or prepare reagents. In addition, the pretreatment operation steps are also simple. Just place the blood collection tube directly after centrifugation. However, these are based on optical measurements such as absorbance measurement, and when a substance containing a pigment such as hemoglobin is contained, for example, when whole blood is measured, accurate measurement values ​​cannot be obtained. In other words, it is impossible to accurately measure in the case of hemolysis.

[0033] HPLC devices are usually able to perform relatively accurate measurements even in the case of hemolysis. These are dedicated devices, so the unit cost is high, a large space (floor area) is required, and the measurement time is long. However, multiple HPLC devices can be set up in an organization and always run under appropriate management. This can achieve high accuracy and can achieve high efficiency and low cost overall.

[0034] <Other ingredients>

[0035] In some embodiments, the solution may contain a buffer and a salt as active ingredients. In some embodiments, the solution may contain an active ingredient consisting of a buffer and a salt as an active ingredient. In some embodiments, the solution may contain a buffer, a salt, and water. In some embodiments, the solution may consist essentially of a buffer, a salt, and water.

[0036] In some embodiments, the solution may contain ingredients other than buffers and salts. In some embodiments, the solution preferably does not contain albumin and glycated albumin, or ingredients that have a substantial effect on the determination. For example, it is preferred not to use some preservatives. For example, it is preferred not to use ProClin (registered trademark). It is preferred not to use CMIT and / or MIT. It is preferred not to use meropenem trihydrate. The inventors have found that these ingredients tend to give GA values ​​that are higher than the actual ones (not shown).

[0037] <Example>

[0038] The following is an explanation of the examples: A blood sample was diluted with the diluent according to the embodiment of the present invention, and the GA value was measured using HPLC after 0 to 2 days.

[0039] <Preparation of measurement samples>

[0040] A diluent (HEPES buffer) is dispensed into a 1.5 mL tube to introduce a certain amount of blood sample (10 μL, see below) to achieve the desired dilution ratio. A dilution series from 2× to 120× is prepared. The dilution ratio and the amount of diluent dispensed into the tube are as follows. 2×: 10 μL, 5×: 40 μL, 8×: 70 μL, 10×: 90 μL, 40×: 190 μL. In this specification, for example, "10 times" or "10× diluent" refers to a sample prepared by mixing 10 μL of a whole blood sample and 90 μL of a diluent.

[0041] Venous blood was collected using a vacuum blood collection tube containing an anticoagulant. Glucose was added to the tube to give a glucose concentration of 1000 mg / dL. 10 μL of the whole blood was dispensed into each of the tubes prepared above and mixed by slowly inverting the mixture to prevent hemolysis.

[0042] The samples were measured on the same day (“Day 0”), or stored in a 37°C thermostat for one day (“Day 1”) or two days (“Day 2”) before being measured.

[0043] Before the measurement, a diluent was added to the 2× to 8× diluted solution to achieve the same concentration as the 10× diluted solution, and blood cells were removed by centrifugation. For the 10×, 40×, and 120× diluted solutions, no diluent was added, and blood cells were removed by centrifugation. Then, half the amount of the eluent was added to the 2× to 10× diluted solution, and 20 μL of it was introduced into the HPLC device. For the 40× and 120× diluted solutions, no diluent was added, and ethanol was added to a final concentration of 4%, and 40 μL and 100 μL were introduced into the HPLC device, respectively.

[0044] <HPLC measurement>

[0045] The measurement conditions refer to "Detection of GA by HPLC" J Chromatogr 597, 271-275 (1992). The columns used were AEX: Shodex-Asahipak ES-502N (7.5 mm ID × 100 mm) (Showa Denko K.K.) and BAC: TSKgelBoronate-5PW (4.6 mm ID × 100 mm) (Tosoh Corporation). The eluents used were glycine (JIS special grade), magnesium chloride hexahydrate (JIS special grade), D(-)-sorbitol (Wako grade 1), ethanol (99.5%, JIS special grade), tris(hydroxymethyl)aminomethane (Tris, biotechnology grade), and EDTA·2Na. The analysis was performed using a Prominence HPLC system equipped with a system controller (Shimadzu Corporation).

[0046] <Example 1>

[0047] Prepare the dilutions as follows:

[0048] HEPES 10mM

[0049] NaCl 150mM

[0050] Volume 90 μL

[0051] pH 8.0

[0052] Figure 1 The relative GA values ​​of the preparation day "Day 0" and two days later "Day 2" are shown. At each dilution ratio, the GA% of "Day 0" was set as 100% and the ratio (GA% change rate) of the GA% of "Day 2" to that was calculated.

[0053] In the case of 2× to 8×, GA% changes significantly over time. It is speculated that the reason is that the glucose present in the sample reacts with albumin, and the saccharification degree of albumin increases. In the case of 8× dilution, an increase in GA% over time was also observed, but the rate of increase was suppressed relative to the range of 5× or higher. It can be seen that the dilution of 8× has the effect of inhibiting glycation. In contrast, in the case of 10× and more dilute dilutions, the change of GA% over time is small. This result suggests that the increase in the saccharification degree of albumin caused by the reaction of glucose with albumin at these dilution ratios is suppressed or does not cause substantial problems.

[0054] Figure 1 As an example, the threshold is set to ±3%. That is, when the change rate of GA% is 97% to 103% (100±3%), it is determined that GA% has not changed substantially. This threshold is an example and can also be set to other values. The threshold can be determined based on the accuracy of the measurement, the desired accuracy, etc. In the case of 10× to 120×, the fluctuation range is less than 3%, and stops at a range of about 2%.

[0055] There is a concern that the HPLC measurement may not be performed correctly if the dilution ratio is too large. However, in the inventors' experiments, no problem was observed at a dilution ratio of 125×.

[0056] In some embodiments, the upper limit of the dilution ratio can be determined by the amount of diluent actually used. For example, in a blood sample transport kit, a container (such as a tube) for containing a mixed solution of the diluent and the blood sample can be used. As an example, the fingertip blood collected is about 10 μL, and the capacity of the tube is about 1.5 mL. At this time, the volume of the diluent that can be added to the tube is at most about 1.4 mL, and the dilution ratio is about 140×. Taking into account the movement of blood from the blood collection kit into the tube, etc., the volume of the diluent that can be added to the tube can be less than this volume. The above is an example, and the maximum dilution ratio can be determined by other transport or storage conditions including weight and size.

[0057] <Example 2>

[0058] In this example, the following dilution solutions were prepared.

[0059] Sodium acetate 100mM

[0060] NaCl 80mM

[0061] Volume 90 μL

[0062] pH 8.4

[0063] The whole blood sample was diluted 10-fold with a diluent containing sodium acetate as a buffer in this example, and the rate of change of the GA value was measured. Figure 2 The results compared with the dilution solution containing HEPES in Example 1 are shown.

[0064] Depend on Figure 2 It is found that when sodium acetate is used as a buffer, the change in GA value over time is suppressed within an acceptable range, similarly to when HEPES is used as a buffer.

[0065] <Blood collection / dilution storage / transport kit>

[0066] use Figure 3 and Figure 4 A method for storing or transporting fingertip blood according to one embodiment is described. A puncture instrument such as a lancet (not shown) is used to allow blood (fingertip blood) 210 to flow out from the body surface 200 of a subject (object, user). A blood collection tube 110 has a tubular structure, a portion of which has a capillary 111. The front end opening 112 of the capillary 111 is brought into contact with the fingertip blood 210 (A). The fingertip blood 210 is collected inside the capillary 110 based on the capillary phenomenon (B).

[0067] Prepare a tube 120 containing a diluent 130 (C). Insert the blood collection tube 110 with the collected blood 210 into the tube 120 with the capillary facing downward (D). At this time, it is preferred that the front end 112 of the capillary 111 reaches the liquid surface of the diluent 130 in the tube 120. Thus, the blood 210 in the capillary 111 falls into the diluent. Here, wait until most of the blood in the capillary falls into the diluent. The blood 210 moves in the diluent 130 to form a mixed solution 131 (E).

[0068] The blood collection tube 110 has a tubular structure, and a capillary tube 111 formed at one end and a cylinder 113 formed at the other end are coaxially fluidically connected.

[0069] The plunger 140 is inserted from the top into the barrel 113 of the blood collection tube 110. The pressure inside the barrel 113 increases, and the liquid in the capillary 111 is squeezed out. As a result, the remaining blood 210 is forced out (F). As a result, the amount of the blood sample 210 remaining in the capillary 111 is reduced, and the blood sample can be effectively used for measurement.

[0070] After the residual blood sample 210 in the blood collection tube 110 is fully squeezed out, the plunger 140 is pulled up to remove the blood collection tube 110 connected to the plunger 140 from the tube 120 (G). As a result, the mixed solution 131 of the blood sample and the diluent remains in the tube 120. If the blood collection tube remains in the tube, the blood sample may adhere to the blood collection tube due to shaking during transportation and storage. Removing the residue in the blood collection tube and / or removing the blood collection tube itself from the tube can, for example, improve the recovery efficiency of the measurement object in the blood sample, and also, for example, reduce the risk of hemolysis.

[0071] The tube 120 is closed with a cap 150. A mixed solution 131 of a blood sample and a diluent is sealed in the tube 120. In this state, the mixed solution 131 is transported and / or stored in the tube 120.

[0072] Conventional blood test kits (e.g., DEMECAL (registered trademark) Li-Jia Company) have factors that become obstacles in HPLC measurement. Such solutions are prepared in a manner to separate blood components in order to avoid hemolysis problems. Sometimes, a large amount of blood sample, such as 50 μL, is required for separation or multiple measurements. In addition, when a plasma separation filter is used, a portion of blood will remain on the filter. Therefore, it is impossible to obtain a sufficient amount of separation solution from a trace amount of blood.

[0073] According to some embodiments, the trace amount of blood transported or stored can be whole blood. After blood collection, the trace amount of whole blood can be transported or stored. Plasma separation may not be performed. In methods for transporting and storing blood samples for analyzing substances other than a variety of blood cell components, plasma separation is usually performed in advance. In contrast, the present invention provides a technology for transporting or storing trace amounts of blood without plasma separation. In some embodiments, the collected trace amount of blood can be diluted. By diluting, the handling of the trace amount of blood becomes easy.

[0074] According to some embodiments of the present invention, there is no need to separate blood components. According to some embodiments of the present invention, there is no need for a plasma separation filter. As a result, the loss of blood recovery due to the blood remaining in the plasma separation filter can be avoided. There is no need for components such as a syringe for passing the collected blood through the filter. The loss of recovery due to blood adhering to the surfaces of these components and the inside of the syringe can also be avoided. Therefore, the collected trace amount of blood can be used efficiently.

[0075] In the present invention, for example, a measurement method that is not affected by hemolysis can be used. For example, HPLC can be used. For example, GA measurement using HPLC is not easily affected by hemolysis. The GA value can also be measured by transporting a small amount of blood (trace blood). The GA value is not an absolute value such as concentration, but a ratio of the amount of glycated albumin to the amount of total albumin, that is, a relative value. Therefore, although the fact that the amount collected is a trace amount affects the accuracy of the concentration measurement (fluctuation, etc.), it has little effect on the GA value measurement.

[0076] GA values ​​usually fluctuate at intervals of about 1 to 2 weeks, so by measuring them regularly at intervals of 1 to 2 weeks, they can be effectively used for blood sugar control. Therefore, low-invasive or minimally invasive blood collection is effective. Small amounts of blood collected reduce the invasiveness, i.e., the physical or psychological burden on the user. For example, making the needle of a lancet thinner can reduce pain. In addition, operational burdens such as squeezing out puncture blood, repeated collection, separation of blood components, and maintenance of plasma separation status can be avoided or reduced. Furthermore, there is no need for a complex component structure, which can reduce the cost of the test kit and the cost of each measurement.

[0077] Among them, in some embodiments of the present invention, blood components can be separated. The trace amount of blood transported or stored can be a plasma or serum component. In some embodiments of the present invention, the solution can contain components that avoid or reduce hemolysis. The collected trace amount of blood is prone to drying, coagulation and / or hemolysis when not diluted. These phenomena may have a significant impact on the measurement. Therefore, there is also a risk of increasing the number of blood samples that are not suitable for measurement. In some embodiments of the present invention, these risks can be reduced or avoided by performing appropriate dilution.

[0078] According to one embodiment of the present invention, the solution does not contain albumin and glycated albumin, or components that have a substantial effect on the determination. For example, the solution does not contain some preservatives. For example, the solution does not contain ProClin (registered trademark), CMIT, MIT and / or meropenem trihydrate.

[0079] The present invention includes the following embodiments:

[0080] A001

[0081] A solution for transporting or storing a small amount of blood,

[0082] Contains buffers and salts as active ingredients,

[0083] The composition is configured to dilute a trace amount of blood at a dilution ratio greater than 8 times.

[0084] A001b

[0085] A solution for transporting or storing a small amount of blood,

[0086] Contains buffers and salts as active ingredients,

[0087] The method is configured to dilute a trace amount of blood at a dilution rate of substantially 10 times or more.

[0088] A011

[0089] The solution according to A001 or any one of the embodiments, wherein the trace amount of blood is capillary blood.

[0090] A012

[0091] The solution according to A001 or A011 or any one of the embodiments, wherein the trace amount of blood is collected by puncture.

[0092] A013

[0093] The solution according to any one of items A001 to A012 or any one of embodiments, wherein the trace amount of blood is collected from a fingertip, an earlobe, a sole, an arm or an abdomen.

[0094] A014

[0095] The solution according to any one of A001 to A013 or any one of the embodiments, wherein the trace amount of blood is 0.5 to 20 μL.

[0096] A015

[0097] The solution according to any one of items A001 to A014 or any one of embodiments, wherein the trace amount of blood is whole blood.

[0098] A021

[0099] The solution according to any one of A001 to A014 or any one of the embodiments, wherein the dilution rate is 9 times or more.

[0100] A022

[0101] The solution according to any one of A001 to A021 or any one of embodiments, wherein the dilution rate is 10 times or more.

[0102] A031

[0103] The solution according to any one of A001 to A022 or any one of embodiments, wherein the buffer is selected from the group consisting of HEPES, sodium acetate and PBS.

[0104] A041

[0105] The solution according to any one of A001 to A031 or any one of embodiments, wherein the salt is selected from the group consisting of NaCl, KCl, MgCl and CaCl.

[0106] A051

[0107] The solution according to any one of A001 to A041 or any one of the embodiments, wherein the active ingredient is adjusted so that the solution becomes isotonic with respect to blood cell components.

[0108] A061

[0109] The solution according to any one of A001 to A051 or any one of the embodiments, which is used for measuring the GA value during transportation or after a storage period.

[0110] B001

[0111] A method comprising the following steps:

[0112] Providing a blood collection tube having a capillary tube and a barrel fluidically connected to the capillary tube;

[0113] Provide a tube for receiving the diluent;

[0114] Collect fingertip blood into a capillary blood collection tube;

[0115] The blood collection tube containing the fingertip blood is introduced into the tube in such a manner that the tip of the capillary tube contacts the diluent;

[0116] Waiting for the fingertip blood in the blood collection tube to fall into the diluent;

[0117] Inserting a plunger into the barrel and squeezing out the liquid in the capillary tube;

[0118] removing said plunger and said blood collection tube from said tube; and

[0119] The tube is closed to seal the mixed solution of the diluent and the fingertip blood in the tube.

[0120] C001

[0121] A kit for mailing a trace amount of blood, comprising the solution described in any one of A001 to A061 or any one embodiment.

[0122] C011

[0123] A kit comprising:

[0124] a) the solution of any one of A001 to A061 or any one of the embodiments;

[0125] b) A tube configured to contain the above solution and receive a small amount of blood.

[0126] C012

[0127] The kit according to C011 or any one of the embodiments, further comprising c) a blood collection tube having a capillary tube and configured to collect a predetermined volume of blood.

[0128] C013

[0129] According to the kit described in C011 or C012 or any one of the embodiments, the amount of the solution is 90 μL, and the volume of blood that can be collected by the blood collection tube is 10 μL.

[0130] C014

[0131] The kit according to any one of C001 to C013 or any one of the embodiments, further comprising d) a plunger configured to be inserted into the blood collection tube and squeeze out the blood in the capillary tube.

[0132] C015

[0133] The kit according to any one of C001 to C013 or any one of the embodiments, further comprising e) a puncture tool for blood collection.

[0134] C016

[0135] The kit according to any one of items C001 to C015 or any one of the embodiments, wherein the amount of the solution is 90 μL, and the trace amount of blood is puncture blood.

[0136] D001

[0137] A method for transporting or storing a trace amount of blood, comprising the following steps:

[0138] Providing the solution described in any one of A001 to A061 or any one embodiment;

[0139] Collecting a small amount of blood; and

[0140] The above-mentioned trace amount of blood is mixed with the above-mentioned solution to prepare a diluent.

[0141] D002

[0142] The method according to D001 or any one of the embodiments further comprises the step of transporting the prepared diluent from the place where the trace amount of blood is collected to another place.

[0143] Several embodiments and examples of the present invention have been described above, but these embodiments and examples are illustrative of the present invention. For example, the above-mentioned embodiments are described in detail in order to explain the present invention in an easy-to-understand manner, and the size, structure, material, and circuit can be additionally changed as needed. It should be noted that an embodiment in which one or more of the above-mentioned features of the present invention are arbitrarily combined is also included in the scope of the present invention. Without departing from the technical idea of ​​the present invention, the claims include a variety of variations of the embodiments. Therefore, the embodiments and examples disclosed in this specification are shown for illustration and should not be considered to limit the scope of the present invention.

Claims

1. A solution for transporting or preserving a small amount of blood, Contains buffers and salts as active ingredients, The composition is configured to dilute a trace amount of blood at a dilution ratio greater than 8 times.

2. The solution according to claim 1, wherein The trace amount of blood is capillary blood.

3. The solution according to claim 1, wherein The trace amount of blood is whole blood.

4. The solution according to claim 1, wherein The minute amount of blood is 0.5 to 20 μL.

5. The solution according to claim 1, wherein The dilution rate is substantially 10 times or more.

6. The solution according to claim 1, wherein The buffer is selected from the group consisting of HEPES, sodium acetate and PBS.

7. The solution according to claim 1, wherein The salt is selected from the group consisting of NaCl, KCl, MgCl and CaCl.

8. The solution according to claim 1, wherein The active ingredient is adjusted so that the solution becomes isotonic with respect to blood cell components.

9. The solution according to claim 1, which is used for measuring GA value during transportation or after a storage period.

10. A kit for mailing a trace amount of blood, comprising the solution according to any one of claims 1 to 9.

11. A kit comprising: a) a solution as claimed in any one of claims 1 to 9; b) A tube constructed in such a way as to enclose the solution and receive a trace amount of blood.

12. The kit according to claim 11, wherein The device further comprises c) a blood collection tube configured to collect a predetermined volume of blood.

13. The kit according to claim 11 or 12, wherein The volume of the solution is 90 μL, The blood collection tube can collect a volume of 10 μL of blood.

14. A plunger, which is the kit according to claim 11 or 12, wherein: The plunger is d) a plunger configured to be inserted into the blood collection tube and squeeze out the blood in the capillary tube.

15. The kit according to claim 11 or 12, wherein It also has e) a puncture device for blood collection.

16. A method for transporting or storing a trace amount of blood, comprising the following steps: Providing a solution as claimed in any one of claims 1 to 9; Collecting a small amount of blood; and The minute amount of blood is mixed with the solution to prepare a diluent.

17. The method according to claim 16, wherein: The minute amount of blood mixed with the solution is whole blood.

18. The method according to claim 17, wherein: The method further comprises the step of transporting the prepared diluent from the location where the trace amount of blood is collected to another location.

19. A method comprising the following steps: Providing a blood collection tube having a capillary tube and a barrel fluidically connected to the capillary tube; Provide a tube for receiving the diluent; Collect fingertip blood into a capillary blood collection tube; The blood collection tube containing the fingertip blood is introduced into the tube in such a manner that the front end of the capillary tube contacts the diluent; Waiting for the fingertip blood in the blood collection tube to fall into the diluent; inserting a plunger into the barrel and squeezing out the liquid present in the capillary tube; removing the plunger and the blood collection tube from the tube; as well as The tube is closed to seal the mixed solution of the diluent and the fingertip blood in the tube.