Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/15003—Source of blood for venous or arterial blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150358—Strips for collecting blood, e.g. absorbent
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150503—Single-ended needles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15142—Devices intended for single use, i.e. disposable
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/02—Adapting objects or devices to another
  • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/18—Transport of container or devices
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/04—Moving fluids with specific forces or mechanical means
  • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
  • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/04—Moving fluids with specific forces or mechanical means
  • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure

Definitions

• the present disclosure relates to solutions and methods for transporting or storing small amounts of blood.
• glycated albumin in the blood.
• Glycoalbumin is a glycation product of albumin.
• Albumin is present in large amounts in the body and is a protein that has a high binding rate with glucose.
• the degree of glycation of glycated albumin (GA) (GA value or GA%) is said to represent the average blood glucose level over the past approximately two weeks. For this reason, the GA value has been attracting attention in recent years as an indicator to be used in blood glucose control and management.
• GA values should desirably be measured more frequently than regular blood tests. For this reason, one effective method is to perform transport testing rather than testing at a hospital. Specifically, the user collects a small amount of blood, such as from a fingertip, and sends it to a testing facility via a transport method such as mail.
• the testing facility can have measuring equipment that can perform tests with high efficiency and high accuracy, and can provide the test results to the user and related institutions.
• Glucose or other components in whole blood may react with albumin during transport or storage, affecting the final actual GA value and potentially affecting the measurement of GA values.
• a solution for transporting or storing a blood sample is provided.
• the blood sample may be a trace blood sample.
• the solution may include buffers and salts as active ingredients. The solution may be configured to dilute blood at a dilution ratio of greater than 8 times.
• FIG. 1 is a graph showing the change in GA value over time at different dilution rates in one example. Graph showing the change in GA value over time in two examples.
• FIG. 1 is a conceptual diagram illustrating the steps of using a mail-order kit containing a diluent according to one embodiment.
• FIG. 1 is a conceptual diagram illustrating the steps of using a mail-order kit containing a diluent according to one embodiment.
• the blood sample can be provided in various ways.
• the blood sample may be capillary blood.
• the blood sample may be collected from a vein or artery of a living body.
• the blood sample may be collected by a puncture method.
• the blood sample may be collected from droplets (capillary blood) generated on the skin by puncturing a fingertip, earlobe, sole of the foot, arm, abdomen, etc.
• the blood sample may be collected by the subject himself/herself.
• the blood sample may be collected by a doctor, nurse, or clinical laboratory technician.
• the blood sample may be collected near a testing device (e.g., a clinic where the testing device is installed).
• the volume may be equal to or greater than 0.1 ⁇ L, 0.2 ⁇ L, 0.3 ⁇ L, 0.4 ⁇ L, 0.5 ⁇ L, 0.6 ⁇ L, 0.7 ⁇ L, 0.8 ⁇ L, 0.9 ⁇ L, 1.0 ⁇ L, 1.1 ⁇ L, 1.2 ⁇ L, 1.3 ⁇ L, 1.4 ⁇ L, 1.5 ⁇ L, 1.6 ⁇ L, 1.7 ⁇ L, 1.8 ⁇ L, 1.9 ⁇ L, 2.0 ⁇ L, etc.
• the volume may be equal to or less than 1.0 ⁇ L, 1.5 ⁇ L, 2 ⁇ L, 3 ⁇ L, 4 ⁇ L, 5 ⁇ L, 6 ⁇ L, 7 ⁇ L, 8 ⁇ L, 9 ⁇ L, 10 ⁇ L, 15 ⁇ L, etc.
• 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.
• dilution ratio or “Nx” used in this specification refers to (V0+V1)/V0 when a volume of diluted solution of V1 is used for a volume of collected blood of V0.
• the dilution ratio is "10 times" or "10x”.
• albumin reacts with glucose present in the blood during transportation or storage, resulting in glycation, which can cause fluctuations in the measured value.
• rate of glycation increases according to the frequency of physical contact between albumin and glucose. Diluting the blood sample reduces this frequency, thereby contributing to suppressing the rate of glycation.
• temperature e.g., room temperature, normal temperature, etc.
• a sufficient dilution rate can be adopted. If the dilution rate is too low, i.e., if a sufficient dilution rate is not adopted, the GA value will fluctuate during transportation, and the subject's GA value cannot be determined accurately.
• the dilution ratio may be equal to or greater than 5x, 6x, 7x, 8x, 9x, 10x, etc. In some embodiments, the dilution ratio may be 5x or greater. In some embodiments, the dilution ratio may be greater than 8x. In some embodiments, the dilution ratio may be 10x or greater.
• the measurement method and device have a concentration limit.
• the albumin concentration in the mixed solution must be greater than that.
• the amount of blood drawn may be small.
• the concentration must be at least within a range that is measurable, either in principle or practically.
• the dilution ratio may be equal to or less than 10x, 15x, 20x, 25x, 30x, 40x, 50x, 60x, 70x, 80x, 90x, 100x, etc. In some embodiments, the dilution ratio may be 100x or less. In some embodiments, the dilution ratio may be 90x or less. In some embodiments, the dilution ratio may be 80x or less. In some embodiments, the dilution ratio may be 50x or less. In some embodiments, the dilution ratio may be 20x or less.
• the dilution ratio may be between 5x and 100x. In some embodiments, the dilution ratio may be between 8x and 100x. In some embodiments, the dilution ratio may be between 9x and 100x. In some embodiments, the dilution ratio may be between 10x and 100x.
• the solution may include a buffering agent, which may be selected from the group consisting of HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), sodium acetate, and PBS (phosphate buffered saline).
• a buffering agent which may be selected from the group consisting of HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), sodium acetate, and PBS (phosphate buffered saline).
• the solution may include a salt.
• the salt may be, for example, but not limited to, NaCl, KCl, etc. In some embodiments, the salt may be NaCl.
• the solution may be adjusted to be isotonic with respect to blood cell components. This can suppress hemolysis. Hemolysis generally does not affect HPLC measurements. However, if components such as hemoglobin released by hemolysis are denatured or modified by heat or over time, they may affect HPLC measurements. Alternatively, hemolysis may affect optical measurements such as absorbance measurements. Therefore, suppressing hemolysis during transportation or storage reduces the risk of measurements becoming impossible or inaccurate.
• GA levels may be measured using HPLC. In some embodiments, GA levels may be measured using an enzyme method or the like.
• Absorbance measurement devices using the enzymatic method are generally low-cost and do not require a large amount of space. Furthermore, commercially available reagents can be used, and no condition setting or reagent preparation is required. Furthermore, the pretreatment process is simple. The centrifuged blood collection tubes need only be placed on the device. However, these devices are based on optical measurements such as absorbance measurement, and cannot obtain accurate measurement values when the device contains substances with pigments such as hemoglobin, for example when measuring whole blood. In other words, accurate measurements cannot be made in the case of hemolysis.
• HPLC devices can generally perform relatively accurate measurements, even in cases of hemolysis. Because these are dedicated machines, they are expensive per unit, require a large space (footprint), and have long measurement times. However, multiple HPLC devices can be installed in a facility and operated under constant proper management. This allows for high accuracy as well as overall high efficiency and low costs.
• the solution may include a buffer and a salt as active ingredients.
• the solution may include an active ingredient consisting of a buffer and a salt as active ingredients.
• the solution may include a buffer, a salt, and water.
• the solution may consist essentially of a buffer, a salt, and water.
• the solution may contain ingredients other than buffers and salts.
• the solution preferably does not contain albumin and glycoalbumin, or ingredients that substantially affect the measurement.
• CMIT and/or MIT It is preferable to avoid meropenem trihydrate.
• the inventors have found that these ingredients tend to give GA values that are higher than they actually are (not shown).
• Example> Examples will be described below.
• a blood sample was diluted with a diluent according to an embodiment of the present disclosure, and the GA value was measured by HPLC after 0 to 2 days.
• diluent HEPES buffer
• a dilution series from 2 ⁇ to 120 ⁇ was prepared.
• the dilution ratios and the amount of diluent dispensed into the tubes are as follows: 2 ⁇ : 10 ⁇ L, 5 ⁇ : 40 ⁇ L, 8 ⁇ : 70 ⁇ L, 10 ⁇ : 90 ⁇ L, 40 ⁇ : 190 ⁇ L.
• "10 times" and "10 ⁇ diluent” refer to a sample prepared by mixing 10 ⁇ L of whole blood sample with 90 ⁇ L of diluent.
• Venous blood was collected using a vacuum blood collection tube containing an anticoagulant. Glucose was added to this to make the glucose concentration 1000 mg/dL.
• Whole blood was mixed by slowly inverting and dispensed in 10 ⁇ L portions into the tubes prepared above, and mixed to avoid hemolysis.
• Samples were measured on the same day (day 0), or stored in a 37°C incubator for one day (day 1), or stored for two days (day 2), and then measured.
• diluent Prior to measurement, diluent was added to the 2x to 8x diluted solutions to give the same concentration as the 10x diluted solution, and blood cells were removed by centrifugation. Blood cells were removed from the 10x, 40x, and 120x diluted solutions by centrifugation without the addition of diluent. Next, half the amount of eluent was added to the 2x to 10x diluted solutions, and 20 ⁇ L of this was introduced into the HPLC system. Ethanol was added to the 40x and 120x diluted solutions to a final concentration of 4% without the addition of diluent, and 40 ⁇ L and 100 ⁇ L, respectively, were introduced into the HPLC system.
• 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 (Shimadzu Corporation) equipped with a system controller.
• Example 1 The dilutions were prepared as follows: HEPES 10mM NaCl 150 mM Volume 90 ⁇ L pH 8.0
• Figure 1 shows the relative GA values on the same day as preparation (day 0) and the day after (day 2). For each dilution ratio, the GA% on “day 0" was set to 100%, and the ratio of the GA% on “day 2" to this (the rate of change in GA%) was calculated.
• the GA% changed significantly over time. This is presumably because the glucose present in the sample reacted with albumin, increasing the degree of glycation of albumin.
• 8x dilution an increase in the GA% over time was also observed, but the rate of increase was suppressed compared to the 5x or higher range. It was also found that a dilution level of 8x has the effect of suppressing glycation.
• the change in the GA% over time was small. This result suggests that at these dilution rates, the reaction of glucose with albumin and the increase in the degree of glycation of albumin is suppressed, or does not become a substantial problem.
• the threshold is set to ⁇ 3% as an example. In other words, when the rate of change of the GA% is between 97% and 103% (100 ⁇ 3%), it is determined that the GA% has not changed substantially.
• This threshold is only an example and may be set to another value. The threshold may be determined based on the measurement accuracy, the desired accuracy, etc. At 10x to 120x, the fluctuation range is less than 3%, remaining in the range of about 2%.
• the upper limit of the dilution ratio may be determined by the amount of diluting solution actually used.
• a blood sample transport kit may use a container (e.g., a tube) that contains a mixed solution of diluting solution and blood sample.
• the fingertip blood to be collected is about 10 ⁇ L
• the capacity of the tube is about 1.5 mL.
• the maximum volume of diluting solution that can be put into the tube is about 1.4 mL
• the dilution ratio is about 140x.
• the volume of diluting solution that can be put into the tube may be smaller than this.
• the maximum dilution ratio may be determined by other transport or storage conditions, including weight and size.
• Example 2 In this example, the following dilutions were prepared: Sodium acetate 100mM NaCl 80 mM Volume 90 ⁇ L pH 8.4
• Blood (fingert blood) 210 is drawn from a body surface 200 of a subject (target person, user) using a puncture device (not shown) such as a lancet.
• a blood collection tube 110 has a tubular structure, and has a capillary tube 111 in a part of it. The tip opening 112 of the capillary tube 111 is brought into contact with the fingertip blood 210 (A).
• the fingertip blood 210 is contained inside the capillary tube 110 by capillary action (B).
• a tube 120 containing diluent 130 is prepared (C).
• a blood collection tube 110 with collected blood 210 is inserted into the tube 120 with the capillary facing downwards (D).
• D the capillary facing downwards
• the tip 112 of the capillary 111 reaches the liquid surface of the diluent 130 in the tube 120. This causes the blood 210 in the capillary 111 to fall into the diluent.
• the blood 210 moves into the diluent 130, and a mixed solution 131 is formed (E).
• the blood collection tube 110 has a tubular structure, with a capillary tube 111 formed at one end and a cylinder 113 formed at the other end that are coaxially fluid-connected.
• the plunger 140 is inserted into the cylinder 113 of the blood collection tube 110 from above.
• the pressure inside the cylinder 113 increases, forcing the liquid inside the capillary tube 111 to the outside. This forces the remaining blood 210 to the outside (F). This reduces the amount of blood sample 210 remaining inside the capillary tube 111, allowing the blood sample to be used effectively for measurement.
• the plunger 140 is pulled up and the blood collection tube 110 connected to the plunger 140 is removed from the tube 120 (G). As a result, a mixture 131 of the blood sample and 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 procedures. Removal of the residue in the blood collection tube and/or removal of the blood collection tube itself from the tube can, for example, increase the efficiency of recovery of the measurement target in the blood sample and, for example, reduce the risk of hemolysis.
• the tube 120 is closed with the lid 150.
• the mixed solution 131 of the blood sample and diluent is sealed inside the tube 120. In this state, the mixed solution 131 is transported and/or stored inside the tube 120.
• the small amount of blood to be transported or stored may be whole blood. After collection, a small amount of whole blood may be transported or stored. Plasma separation may not be performed. In methods for transporting and storing blood samples for analysis of substances other than many blood cell components, it has been common to perform plasma separation beforehand. In contrast, the present disclosure provides a technique for transporting or storing a small amount of blood without plasma separation. In some embodiments, the collected small amount of blood may be diluted. Dilution makes it easier to handle the small amount of blood.
• separation of blood components is not required.
• a plasma separation filter is not required. This makes it possible to avoid loss of blood recovery due to blood remaining in the plasma separation filter. Components such as a syringe for passing the collected blood through the filter are also not required. It is also possible to avoid loss of blood recovery due to blood adhering to these components or to the inner surface of the syringe. Therefore, the minute amount of collected blood can be used efficiently.
• a measurement method that is not affected by hemolysis can be used.
• HPLC may be used.
• GA measurement using HPLC is less affected by hemolysis. It makes it possible to measure the GA value by transporting a small amount of blood (microvolume blood).
• the GA value is not an absolute amount such as concentration, but is the ratio of the amount of glycated albumin to the amount of total albumin, i.e., a relative value. Therefore, although the fact that the amount collected is microscopic may affect the accuracy of the concentration measurement (such as fluctuation), the effect on the GA value measurement is relatively small.
• GA values generally fluctuate at intervals of about 1-2 weeks, so regular measurements at 1-2 week intervals can be used to control blood sugar. For this reason, low-invasive or minimally invasive blood sampling is effective. A small amount of blood is collected, which reduces the invasiveness, i.e. the physical or psychological burden, on the user. For example, the lancet needle can be made thinner to reduce pain. In addition, it is possible to avoid or reduce the workload of squeezing blood from a puncture, repeated sampling, separating blood components, and maintaining the plasma separation state. Furthermore, there is no need for a complex component configuration, which reduces the cost of the kit and the cost of each measurement.
• blood components may be separated.
• the small amount of blood to be transported or stored may be a plasma or serum component.
• the solution may contain components that avoid or reduce hemolysis. If the small amount of blood collected is not diluted, it is prone to drying, clotting, and/or hemolysis. These phenomena can significantly affect the measurement. There is therefore a risk that the number of blood samples that are not suitable for measurement will increase. In some embodiments of the present disclosure, these risks can be reduced or avoided by appropriate dilution.
• the solution does not contain albumin and glycoalbumin or any other components that would substantially affect the measurement.
• the solution does not contain any preservatives.
• the solution does not contain ProClin®, CMIT, MIT, and/or meropenem trihydrate.
• A001 A solution for transporting or storing a small amount of blood comprising: Contains buffers and salts as active ingredients, configured to dilute the trace blood by a dilution ratio of greater than 8; solution.
• A001b A solution for transporting or storing a small amount of blood comprising: Contains buffers and salts as active ingredients, The device is configured to dilute a small amount of blood at a dilution rate of substantially 10 times or more.
• solution. A011 A001 or any of the embodiments of the solution The trace blood is capillary blood. solution.
• the small amount of blood is collected by a puncture method. solution.
• A013 A solution according to any one of A001 to A012 or any embodiment thereof, comprising The small amount of blood is collected from a fingertip, an earlobe, a sole of a foot, an arm, or an abdomen. solution.
• A014 A solution according to any one of A001 to A013 or any embodiment, comprising The small amount of blood is 0.5 to 20 ⁇ L. solution.
• A015 A solution according to any one of A001 to A014 or any embodiment, comprising The small amount of blood is whole blood. solution.
• A021 A solution according to any one of A001 to A014 or any embodiment, comprising The dilution ratio is 9 times or more. solution.
• A022 A solution according to any one of A001 to A021 or any embodiment, comprising The dilution ratio is 10 times or more. solution.
• A031 A solution according to any one of A001 to A022 or any embodiment thereof, comprising The buffer is selected from the group consisting of HEPES, sodium acetate, and PBS. solution.
• A041 A solution according to any one of A001 to A031 or any embodiment, comprising The salt is selected from the group consisting of NaCl, KCl, MgCl, and CaCl; solution.
• A051 A solution according to any one of A001 to A041 or any embodiment, comprising The active ingredient is adjusted so that the solution is isotonic with respect to blood cell components. solution.
• A061 A solution according to any one of A001 to A051 or any embodiment, comprising Used to measure GA values after transportation or storage period, solution.
• B001 providing a blood collection tube comprising a capillary tube and a cylinder in fluid communication with the capillary tube; providing a tube containing a diluent; Collecting fingerprick blood into a blood collection tube having a capillary tube; introducing the blood collection tube containing the fingerpick blood into the tube such that the tip of the capillary is in contact with the diluent; waiting for the fingerprick blood in the blood collection tube to drip into the diluent; inserting a plunger into said cylinder to expel liquid present in said capillary; removing the plunger and the blood collection tube from the tube; and closing the tube to seal therein the mixture of the diluent and the fingerstick blood; A method for providing the above.
• C001 A kit for mailing a small amount of blood comprising a solution according to any one of A001 to A061 or any embodiment.
• C011 a) a solution according to any one of A001 to A061 or any embodiment; b) a tube containing the solution and configured to receive a small amount of blood;
• a kit comprising:
• C012 The kit of any of the embodiments, comprising: c) A kit further comprising a collection tube having a capillary tube configured to collect a predetermined volume of blood.
• C013 The kit of any of the embodiments described in C011 or C012, comprising: The volume of the solution is 90 ⁇ L, The blood collection tube can collect a volume of 10 ⁇ L of blood. kit.
• C014 The kit of any one of claims C001 to C013 or any embodiment, comprising: d) a plunger configured to be inserted into said blood collection tube and to expel blood within said capillary.
• C015 The kit of any one of claims C001 to C013 or any embodiment, comprising: e) The kit further comprising a blood sampling lancing device.
• C016 The kit of any one of claims C001 to C015 or any embodiment, comprising: The volume of the solution is 90 ⁇ L, The small amount of blood is puncture blood. kit.
• D001 A method for transporting or storing a small amount of blood, comprising: providing a solution according to any one of A001 to A061 or any embodiment; Taking a small amount of blood; and mixing the small amount of blood with the solution to prepare a dilution solution; A method for providing the above.
• D002 The method according to D001 or any embodiment, comprising: The method further comprising transporting the prepared diluent from the location where the blood microvolume was collected to another location.

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