Blood filter paper specimen package, and methods for transporting and storing the same

Abstract

To provide a blood filter paper specimen package that prevents enzyme activity in blood filter paper specimens from decreasing even under high temperature and humidity conditions.SOLUTION: A blood filter paper specimen package comprises an airtight storage section for storing a blood filter paper specimen, and dehumidifying means disposed in the storage section. Further features include the dehumidifying means having the function of maintaining the humidity within the storage section at or below a predetermined humidity level, the storage section being a zipper bag storage section, and the dehumidifying means being a desiccant.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a blood filter paper sample package, a method for transporting and storing the sample. [Background technology]

[0002] Newborn screening is a mass screening of newborns for congenital metabolic disorders, etc. The purpose of newborn screening is to prevent physical and mental disabilities through early detection and treatment of genetic disorders such as those that result from an inability to utilize certain nutrients or an excess or deficiency of growth hormones, which can lead to intellectual disabilities or impaired physical development.

[0003] In Japan, newborn mass screening began as a national project with public funding in October 1977. Currently, newborn mass screening in Japan targets a total of 20 diseases, including galactosemia, a glucose metabolism disorder; congenital hypothyroidism and congenital adrenal hyperplasia, which are endocrine disorders; phenylketonuria and maple syrup urine disease, which are amino acid metabolism disorders; methylmalonic acidemia and propionic acidemia, which are organic acid metabolism disorders; and VLCAD and MCAD, which are fatty acid metabolism disorders.

[0004] Lysosomal diseases, a type of congenital metabolic disorder, are also called lysosomal storage diseases because they are caused by the accumulation of substrates that should be broken down within cells due to a deficiency or reduction in hydrolytic enzymes present in lysosomes (also called "lysosomes" or "lysosomes").

[0005] Lysosomes break down carbohydrates and glycolipids within cells, and approximately 60 types of hydrolases are involved in this process. When the lysosomes are unable to perform their degradative function due to a deficiency or abnormality in these responsible enzymes, substances that should be broken down accumulate in the body as waste products. The collective name for congenital metabolic disorders that arise in this way is lysosomal storage diseases. Symptoms vary depending on the enzyme that is deficient, and there are approximately 30 known disease names, including Fabry disease, Pompe disease, Gaucher disease, mucopolysaccharidosis type I (MPS I), and mucopolysaccharidosis type II (MPS II).

[0006] In the newborn mass screening test, a very small amount of blood is first collected from the heel of a newborn baby 4 to 6 days after birth at an obstetric medical institution onto a filter paper (hereinafter referred to as a blood collection filter paper), and the blood-stained blood collection filter paper (hereinafter referred to as a blood filter paper sample) is then mailed to a screening center affiliated with the obstetric medical institution.

[0007] At the screening center, various measurements are then performed on samples extracted from the blood filter paper specimens. Specific measurement methods used include enzyme-linked immunosorbent assay (ELISA), a method for measuring enzyme activity using a synthetic substrate method (Patent Documents 1 to 4), and a tandem mass spectrometry method (Non-Patent Document 1), and these have demonstrated the usefulness of newborn mass screening tests.

[0008] On the other hand, there is an optional, paid-for expanded screening (also called optional screening) test for diseases that are not included in newborn mass screening and meet five conditions: (a) there is a treatment available, (b) there is a highly accurate test to determine the possibility of having the disease, (c) there are a relatively large number of patients compared to other congenital abnormalities, (d) if the disease is detected before it develops, it can be treated more effectively and prevent symptoms or serious disabilities, and (e) there are few characteristic symptoms, making it difficult to detect through regular medical examinations.

[0009] Expanded screening includes those for lysosomal storage diseases, severe combined immunodeficiency (SCID), and spinal muscular atrophy (SMA). For SCID, DNA of T-cell receptor excision circles (TRECs) and Igκ chain gene rearrangement fragments (KRECs) genes is measured by quantitative PCR in samples extracted from blood filter paper specimens, while DNA of the SMN1 gene is measured in SMA (Patent Documents 5 and 6).

[0010] As mentioned above, the most distinctive feature of newborn mass screening and expanded screening is the use of blood filter paper samples, which are prepared by dropping blood obtained from the heel of a newborn onto a blood collection filter paper (Non-Patent Document 1). The advantages of using blood filter paper samples include: (1) they can be stored at room temperature by air drying (blood metabolite concentrations are maintained for approximately one week); (2) they can be easily mailed from the hospital to the testing institution; (3) each 3 mm diameter punch-out piece contains approximately 3 μL of whole blood, allowing extraction procedures to be performed using a 96-well plate; (4) because they contain cellular components such as red blood cells and white blood cells, they can be used for enzyme activity measurements and DNA analysis; and (5) they can be used as test material for extended periods of time if stored frozen after testing.

[0011] On the other hand, it is important to note that (1) since the blood sample contains whole blood, the measurement target is significantly affected by the concentration within the cells (red blood cells), so pretreatment or other measures are required for each measurement target, (2) if multiple applications are made, the blood concentration may become excessive, and (3) if the sample is hung up to dry, the blood concentration will be higher at the bottom of the dropped spot (Non-Patent Document 1). [Prior art documents] [Patent documents]

[0012] [Patent Document 1] Japanese Patent Application Laid-Open No. 2017-169528 [Patent Document 2] Japanese Patent Application Laid-Open No. 2017-169529 [Patent Document 3] Japanese Patent Application Publication No. 2018-102294 [Patent Document 4] Japanese Patent Application Laid-Open No. 2018-102295 [Patent Document 5] Japanese Patent Publication No. 2022-053961 [Patent Document 6] International Publication No. 2021-020261 [Non-patent literature]

[0013] [Non-Patent Document 1] J.Mass Spectrum.Soc.Jpn.Vol.64(4):127-131(2016) Summary of the Invention [Problem to be solved by the invention]

[0014] Regarding the handling of blood filter paper samples for newborn mass screening, in Japan, the Japan Society of Mass Screening (a general incorporated association) provides guidance in the Newborn Mass Screening Test System Manual, "6. Methods for collecting blood on filter paper, timing of collection, and storage methods" (Journal of the Japan Society of Mass Screening 8:24-27 (1998)).

[0015] The guidelines state that blood filter paper samples (blood filter paper) should be kept horizontally at room temperature for 2 to 4 hours after collection, avoiding high temperatures and humidity (drying with cold air from a dryer is possible), and that blood filter paper samples should be sent on the day of collection or the next day, and that they should not be wrapped in a plastic bag or plastic wrap, but should be placed directly in a special envelope and mailed (if they are placed in a plastic bag, etc., the high temperatures and humidity will cause deterioration and inactivation, making it impossible to obtain accurate measurement values).

[0016] However, with the recent global warming, Japan's trend toward high temperatures and humidity has become increasingly pronounced, with summer temperatures exceeding 30°C (even exceeding 40°C) and humidity levels exceeding 80%. Transporting blood filter paper samples under such harsh conditions can lead to a decrease in enzyme activity in tests for lysosomal storage diseases that measure enzyme activity, particularly in tests for Fabry disease, Pompe disease, Gaucher disease, mucopolysaccharidosis type I (MPS I), and mucopolysaccharidosis type II (MPS II).

[0017] The present inventors conduct newborn mass screening and expanded screening tests at the Newborn Screening Center of KM Biologics Co., Ltd. (located in Kumamoto), but the testing area is not limited to Kumamoto, but extends to Fukuoka, Saga, and Shikoku. Due to the impact of recent revisions to postal services, it has been confirmed that in the case of samples in Shikoku, it sometimes takes about five days from the time of blood collection until they arrive at the testing center.

[0018] Therefore, as a result of extensive research into these problems, the present inventors have discovered a packaging material for blood filter paper specimens that can reduce the decrease in enzyme activity during transport and storage of specimens.

[0019] That is, the present invention has been made in consideration of the above circumstances, and provides a blood filter paper specimen package in which the enzyme activity in the blood filter paper specimen is not likely to decrease even under high temperature and high humidity conditions, as well as a method for transporting and storing the specimen. [Means for solving the problem]

[0020] In order to solve the above-mentioned conventional problems, the blood filter paper specimen package of the present invention has (1) an airtight storage section for storing the blood filter paper specimen, and a dehumidifying means arranged in the storage section.

[0021] The blood filter paper specimen package according to the present invention also has the following features. (2) The dehumidifying means has a function of maintaining the humidity inside the storage section at any one of 70% or less, 60% or less, 50% or less, and 40% or less. (3) The dehumidifying means has a function of maintaining the humidity inside the storage section at 10% or less. (4) The storage section is a storage section of a bag with a zipper. (5) The dehumidifying means is a desiccant.

[0022] In addition, in the method for transporting blood filter paper samples according to the present invention, (6) the blood filter paper sample is contained in the storage section of a packaging body having an airtight storage section and a dehumidifying means arranged in the storage section, and then sealed and transported.

[0023] In addition, in the method for storing blood filter paper samples according to the present invention, (7) the blood filter paper sample is stored in and sealed in the storage section of a packaging body having an airtight storage section and a dehumidifying means arranged in the storage section.

[0024] In addition, in the present invention, (8) a packaging body having an airtight storage section and a dehumidifying means arranged in the storage section is used as a blood filter paper sample transporter for storing blood filter paper samples and transporting them in a sealed state.

[0025] In addition, in the present invention, (9) a packaging body having an airtight storage section and a dehumidifying means arranged in the storage section is used to store blood filter paper samples in a sealed state. [Effects of the Invention]

[0026] The blood filter paper specimen package of the present invention has an airtight storage section for storing the blood filter paper specimen and a dehumidifying means arranged in the storage section, making it possible to provide a blood filter paper specimen package in which the enzyme activity in the blood filter paper specimen is less likely to decrease even under high temperature and high humidity transport conditions.

[0027] Furthermore, if the dehumidifying means has a function of maintaining the humidity inside the storage unit at any one of 70% or less, 60% or less, 50% or less, and 40% or less, the decrease in enzyme activity in the blood filter paper sample can be suppressed. In particular, the lower the humidity, the more the decrease in enzyme activity can be suppressed.

[0028] Furthermore, if the dehumidifying means has the function of maintaining the humidity inside the storage section at 10% or less, it is possible to more reliably suppress the decrease in enzyme activity in the blood filter paper sample.

[0029] Furthermore, if the storage section is a bag with a zipper, it is flexible, soft, and lightweight, and has a small dehumidifying capacity, making it possible to provide a blood filter paper specimen package that is advantageous in terms of ease of handling during transportation and sample stability.

[0030] Furthermore, if the dehumidifying means is a desiccant, the inside of the storage section can be easily dehumidified.

[0031] Furthermore, according to the method for transporting blood filter paper samples of the present invention, the blood filter paper sample is contained in an airtight container section of a packaging body having an airtight container section and a dehumidifying means arranged in the container section, and then sealed and transported.This makes it possible to provide a transportation method that can suppress the decrease in enzyme activity in the blood filter paper sample even under high-temperature, high-humidity transportation conditions.

[0032] Furthermore, according to the method for preserving blood filter paper samples of the present invention, the blood filter paper sample is stored in a sealed storage compartment of a packaging body having an airtight storage compartment and a dehumidifying means arranged in the storage compartment, thereby providing a storage method that can suppress a decrease in enzyme activity in the blood filter paper sample even under high temperature and high humidity conditions.

[0033] In addition, in the present invention, a packaging body having an airtight storage section and a dehumidifying means arranged in the storage section is used as a blood filter paper specimen transporter for storing and sealingly transporting blood filter paper specimens, or for storing and sealingly preserving blood filter paper specimens, thereby preventing a decrease in enzyme activity in the blood filter paper specimens even under high temperature and high humidity conditions. [Brief explanation of the drawings]

[0034] [Figure 1] FIG. 1 is an explanatory diagram showing the results of measuring enzyme activity in Fabry disease. [Figure 2]FIG. 1 is an explanatory diagram showing the results of measuring enzyme activity in Pompe disease. [Figure 3] FIG. 1 is an explanatory diagram showing the results of measuring enzyme activity in Gaucher disease. [Figure 4] FIG. 1 is an explanatory diagram showing the results of measuring the enzyme activity of MPS I disease. [Figure 5] FIG. 1 is an explanatory diagram showing the results of measuring the enzyme activity of MPSII disease. [Figure 6] FIG. 10 is an explanatory diagram showing the results of measuring humidity during storage for 7 days. [Figure 7] FIG. 1 is an explanatory diagram showing the results of measuring the enzyme activity of Fabry disease during storage depending on the material of the blood filter paper specimen package and the type of desiccant. [Figure 8] FIG. 10 is an explanatory diagram showing the results of measuring the enzyme activity of Pompe disease during storage depending on the material of the blood filter paper specimen package and the type of desiccant. [Figure 9] FIG. 10 is an explanatory diagram showing the results of measuring the enzyme activity of Gaucher disease during storage depending on the material of the blood filter paper specimen package and the type of desiccant. [Figure 10] FIG. 1 is an explanatory diagram showing the results of measuring the enzyme activity of MPS I disease during storage depending on the material of the blood filter paper specimen package and the type of desiccant. [Figure 11] FIG. 1 is an explanatory diagram showing the results of measuring the enzyme activity of MPSII disease during storage depending on the material of the blood filter paper specimen package and the type of desiccant. DETAILED DESCRIPTION OF THE INVENTION

[0035] The present invention provides a blood filter paper specimen package that is resistant to the decrease in enzyme activity in the blood filter paper specimen even under high temperature and high humidity conditions.

[0036] In particular, the blood filter paper specimen package according to this embodiment is characterized in that it is provided with a storage section and a dehumidifying means.

[0037] The storage section is a section for storing the blood filter paper sample and is an airtight section. This airtightness (moisture-proofing) is sufficient as long as it can maintain the humidity at a predetermined level or lower using a dehumidifying means (described later), but does not mean that water vapor or other gases are not allowed to pass between the inside and outside of the storage section.

[0038] The storage section may be any storage space that has a certain level of airtightness (moisture resistance) as described above and is large enough to accommodate the blood filter paper sample. It may be a flexible bag or container, or a container such as a hard case. However, the larger the volume of the storage section, the greater the dehumidifying capacity required to maintain the humidity within the storage section at a predetermined level. Therefore, from the perspectives of transportability, storage space, and dehumidifying efficiency, it is best to avoid a capacity that significantly exceeds the capacity required to accommodate the blood filter paper sample and other necessary items. In the following description, the component that forms the storage section (storage space) in constructing the blood filter paper sample package according to this embodiment, such as the bag or container described above, will be referred to as the "storage section."

[0039] The dehumidifying means is used to dehumidify the storage section (storage space), and the dehumidifying mechanism is not particularly limited, and may be moisture absorption as water is used in chemical reactions, adsorption, or a more mechanical method such as heat exchange. One example of a heat exchange method is when a blood filter paper sample is stored or transported in a sealed case in which the high humidity air intake and low humidity air outlet of a dehumidifying device face the storage section as dehumidifying means.

[0040] Furthermore, the blood filter paper specimen package according to this embodiment can suppress a decrease in enzyme activity in the blood filter paper specimen even under high temperature and high humidity conditions.

[0041] Furthermore, the dehumidifying means of the blood filter paper specimen package according to this embodiment may have the function of maintaining the humidity inside the storage section at any one selected from 70% or less, 60% or less, 50% or less, or 40% or less, and more preferably 10% or less. As will be explained later with reference to experimental results, the use of a dehumidifying means having such dehumidifying capabilities can further suppress the decrease in enzyme activity in the blood filter paper specimen under high-temperature and high-humidity conditions.

[0042] The storage section may also be a storage section of a resealable bag, which is a container. This includes, for example, an example in which the blood filter paper sample package according to this embodiment is realized by a resealable bag equipped with (containing) a dehumidifying means.

[0043] That is, one example of a suitable mode of use of the blood filter paper specimen package of the present invention is one in which, before blood collection, it includes a resealable bag as a container and a desiccant as a drying means, and the blood collection filter paper and desiccant are sealed in the container section inside the resealable bag.

[0044] Furthermore, after blood collection, a suitable embodiment of the blood filter paper specimen package according to the present invention includes a resealable bag and a desiccant, and the resealable bag contains a dried blood filter paper specimen, such as a blood filter paper specimen prepared by dripping or soaking human whole blood onto or infiltrating the blood collection filter paper and drying it for several hours, sealed with the desiccant. This embodiment can also be considered an example of a stable package for dried blood filter paper specimens. This configuration can prevent a decrease in enzyme activity in the specimen.

[0045] Resealable bags, also known as plastic bags with a zipper, are storage bags with a zipper on the main body, and are widely used for business and home purposes, such as sorting and storing small parts, organizing small items, collecting money, storing food, etc. They come in a variety of sizes and thicknesses, and can be selected depending on the purpose, such as transparent ones that make the contents easy to see, or ones with a writing area.

[0046] In this embodiment, the resealable bag can be made of polyethylene, polypropylene, aluminum, etc. The film thickness is generally 0.04 mm to 0.08 mm, but thicker bags can be used if necessary. It is preferable that the bag can accommodate the dried blood filter paper without folding it.

[0047] It is also possible to use a bag in which the sealing means for ensuring airtightness is changed from a zipper to another sealing means, such as an adhesive seal, instead of the bag with the zipper described above. That is, although a zipper is advantageous in that it allows the bag to be easily sealed, the sealing means is not particularly limited, and other mechanisms can be used as long as they provide airtightness that can suppress changes over time in humidity and enzyme activity, as described below, to an acceptable level.

[0048] Furthermore, by having such a configuration, the blood filter paper specimen package is flexible, pliable, lightweight, and has a small dehumidification capacity, making it advantageous in terms of ease of handling during transportation and sample stability.

[0049] The dehumidifying means may also be a desiccant. There are various types of desiccants, including silica gel, quicklime, calcium chloride, synthetic zeolite, and clay-based desiccants, but silica gel is preferred as it does not expand when it absorbs moisture. Silica gel is a transparent or blue granular desiccant that comes in a bag. The amount of silica gel to be placed in the resealable bag as a desiccant is preferably 3 g or more.

[0050] In this way, if a desiccant is used as the dehumidifying means, it is possible to easily dehumidify the inside of the storage section.

[0051] The present invention also provides a method for transporting blood filter paper samples. In particular, the method for transporting blood filter paper samples according to this embodiment is characterized in that the blood filter paper sample is contained and transported in a sealed container of a package having an airtight container and a dehumidifying means disposed in the container. This provides a transport method that can suppress a decrease in enzyme activity in the blood filter paper sample even under high-temperature and high-humidity transport conditions.

[0052] The present invention also provides a method for storing blood filter paper samples. In particular, the method for storing blood filter paper samples according to this embodiment is characterized in that the blood filter paper sample is stored in a sealed container of a package having an airtight container and a dehumidifying means disposed in the container, thereby providing a storage method that can prevent a decrease in enzyme activity in the blood filter paper sample even under high-temperature and high-humidity conditions.

[0053] The present invention also proposes that a package having an airtight storage section and a dehumidifying means disposed in the storage section can be used as a blood paper sample transporter for storing and sealingly transporting blood paper samples, or for storing and sealingly storing blood paper samples. When such a package is used as a blood paper sample transporter or for storage, it is possible to suppress the decrease in enzyme activity in the blood paper sample even under high-temperature and high-humidity conditions.

[0054] It should be noted that the packaging and method of the present disclosure that are less likely to reduce enzyme activity in a sample are not limited to those exemplified above.

[0055] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples in any way.

[0056] [Example 1] Preparation of specimens with different storage conditions The blood filter paper samples for the study were prepared by purchasing human whole blood K2EDTA (Cosmo Bio), dripping 50 μL of this into blood filter paper (Toyo Roshi) using a repeat dispenser (Eppendorf), and allowing it to soak into the blood collection filter paper. Immediately after the blood drip, the blood collection filter paper was left horizontally at room temperature for 2 hours to dry, and then used as a blood filter paper sample.

[0057] The test set up 16 storage conditions by combining the following four storage environment conditions and four storage manner conditions, and samples were prepared from blood filter paper specimens at six points: 1 day, 2 days, 3 days, 4 days, 8 days, and 15 days, and then subjected to testing.

[0058] The storage environmental conditions are the temperature and humidity conditions under which blood filter paper samples are stored, and specifically there are four: A: 4°C / humidity 10% or less; B: 25°C / humidity 10% or less; C: 45°C / humidity 10% or less; and D: 45°C / humidity 90% or more.

[0059] The storage conditions are conditions regarding the type of storage and transportation of blood filter paper specimens, and are set assuming transportation in an envelope, which is the type of transportation widely used in newborn mass screening tests in Japan. Specifically, there are four types: 1: envelope only, 2: envelope + zipper bag, 3: envelope + zipper bag + silica gel particles, and 4: envelope + zipper bag + silica gel sheet.

[0060] The zippered bags were made of polyethylene (23cm length x 11cm width below the zipper), and the desiccant used was 3g of silica gel granules (Torihige Sangyo Silica Gel), and a silica gel sheet (Dry Mat Square 40x40mm: Artnap Co., Ltd.). The four storage environmental conditions A to D described above were realized using a constant temperature incubator. Temperature and humidity were also recorded regularly.

[0061] [Example 2] Evaluation of enzymes in five congenital metabolic disorders The blood filter paper specimen package according to this embodiment was evaluated using a method for simultaneously measuring the enzyme activity of the enzymes responsible for five lysosomal storage diseases, including Fabry disease, Pompe disease, Gaucher disease, mucopolysaccharidosis type I (MPS I), and mucopolysaccharidosis type II (MPS II), which are all congenital metabolic disorders (Patent Document 4). The enzyme activity of each of the enzymes responsible for the five lysosomal storage diseases was expressed as a value in pmol / hr / disk, calculated from the fluorescence value of the production of 4-methylumbelliferone (4MU), an enzyme reaction product. On the day of preparation of the six samples described above, samples prepared under each storage condition in Example 1 were immediately taken and measured. The results are shown in Figures 1 to 5.

[0062] As shown in Figures 1 to 5, when the storage conditions were set to A: 4°C / humidity 10% or less, B: 25°C / humidity 10% or less, and C: 45°C / humidity 10% or less, the enzyme activity in the blood filter paper samples tended to decrease over time, but there was no significant difference between the storage conditions.

[0063] On the other hand, when the storage conditions were set at D: 45°C / humidity 90% or higher, enzyme activity in the blood filter paper samples decreased significantly on the second day when only the envelope was used, regardless of the disease.

[0064] Furthermore, by placing silica gel or a desiccant sheet in the storage section of the resealable bag and using the blood filter paper specimen package as a filter paper specimen transporter, it was shown that the decrease in enzyme activity in the blood filter paper specimen can be suppressed compared to the case of using only a resealable bag for specimen transport periods exceeding 4 days.

[0065] [Example 3] Confirmation of humidity inside the container during storage depending on the material of the container and the type of desiccant In constructing the blood filter paper specimen package according to this embodiment, a vinyl bag with a polyethylene zipper (hereinafter simply referred to as a vinyl bag) or a vapor-deposited bag with an aluminum adhesive sealing seal (hereinafter simply referred to as an aluminum vapor-deposited bag) was used as the container, and silica gel or a desiccant sheet was used as the desiccant for dehumidification. The blood filter paper specimen was placed in the container and stored at 45°C / humidity of 70% or more for 7 days, and the change in humidity inside the container of the blood filter paper specimen package during storage was evaluated.

[0066] The conditions for the container and desiccant were A: vinyl bag / silica gel, B: aluminum vapor deposition bag / no desiccant, C: aluminum vapor deposition bag / desiccant sheet, and as a control, D: no container / no desiccant.

[0067] The vinyl bag used as the container measured 16 cm long x 23 cm wide below the zipper, while the aluminum-coated bag measured 34 cm long x 14 cm wide. The desiccant used as the drying means was 3 g of silica gel granules (Torihige Sangyo Silica Gel) or a 3 cm long x 3 cm wide silica gel sheet. While the dehumidifying performance of the silica gel granules and silica gel sheet is not particularly limited, in this example, silica gel granules with dehumidifying performance equivalent to that of general A-type silica gel were used. The dehumidifying performance of the silica gel sheet was 20% or more at a temperature of 25°C and a relative humidity (RH) of 50% or less (30 mm x 30 mm x 0.7 mm). Storage at 45°C and a humidity of 70% or more for 7 days was performed in a constant-temperature incubator, and the temperature inside the constant-temperature incubator and the humidity inside the container were periodically recorded. Figure 6 shows the humidity over time.

[0068] As shown in Figure 6, the humidity inside the storage compartment of the blood filter paper specimen package after 7 days of storage ranged from 61% to 78% for A: plastic bag / silica gel and 58% to 74% for B: aluminum-evaporated bag / no desiccant. B: aluminum-evaporated bag / no desiccant maintained a lower humidity level than A: plastic bag / silica gel. Furthermore, C: aluminum-evaporated bag / desiccant sheet maintained a humidity level of 39% to 59%, demonstrating that the combined use of an aluminum-evaporated bag and a desiccant sheet can maintain a lower humidity level inside the storage compartment. Furthermore, maintaining a humidity level of 70%, 60%, 50%, or 40% inside the storage compartment can suppress the decrease in enzyme activity in blood filter paper specimens during transport within a practical range. Lower humidity levels suppress the decrease in enzyme activity.

[0069] [Example 4] Confirmation of enzyme activity during storage depending on the material of the blood filter paper specimen package and the type of desiccant The specimen was prepared by the method described in Example 1.

[0070] The test conditions were set by combining the following four packaging conditions and four desiccant conditions, and the blood samples were stored in a constant temperature incubator at 45°C and humidity of 70% or higher for 7 days. Samples were prepared from each blood filter paper specimen at five points after 1, 2, 3, 4, and 7 days of storage and submitted for testing.

[0071] The containers used were the same vinyl bags and aluminum-deposited bags as in Example 3, as well as aluminum bags with zippers made by laminating aluminum foil and resin film (hereinafter simply referred to as aluminum bags). The dimensions of the aluminum bags below the zipper were 23.5 cm long and 14 cm wide. The desiccant used as drying means was 3 g of silica gel granules (Torisige Sangyo Silica Gel) or silica gel sheets (3 cm x 3 cm or 6 cm x 6 cm), as in Example 3.

[0072] The combination conditions of the container and desiccant were A1: no container / no desiccant, B1: plastic bag / no desiccant, B2: plastic bag / silica gel, B3: plastic bag / desiccant sheet (3cm x 3cm), B4: plastic bag / desiccant sheet (6cm x 6cm), C1 aluminum vapor deposition bag / no desiccant, C2: aluminum vapor deposition bag / silica gel, C3: aluminum vapor deposition bag / desiccant sheet (3cm x 3cm), C4: aluminum vapor deposition bag / desiccant sheet (6cm x 6cm), D4: aluminum bag / desiccant sheet (6cm x 6cm).

[0073] For each sample stored for 7 days at 45°C / humidity of 70% or higher, the enzyme activities of the enzymes responsible for five lysosomal storage diseases, which are inborn errors of metabolism, namely Fabry disease, Pompe disease, Gaucher disease, mucopolysaccharidosis type I (MPS I), and mucopolysaccharidosis type II (MPS II) were measured using a simultaneous detection method (Patent Document 4) similar to that in Example 2. On the day of preparation of the five samples mentioned above, samples under each storage condition were removed and immediately measured. The results are shown in Figures 7 to 11.

[0074] A tendency for enzyme activity in the blood filter paper samples to decrease over time was observed under each combination of conditions. However, when comparing B1: plastic bag / no desiccant vs. C1: aluminum-coated bag / no desiccant, B2: plastic bag / silica gel vs. C2: aluminum-coated bag / silica gel, B3: plastic bag / desiccant sheet (3cm x 3cm) vs. C3: aluminum-coated bag / desiccant sheet (3cm x 3cm), and B4: plastic bag / desiccant sheet (6cm x 6cm) vs. C4: aluminum-coated bag / desiccant sheet (6cm x 6cm), samples packaged in aluminum maintained higher enzyme activity than those packaged in polyethylene. Furthermore, when comparing the combinations C1: aluminum vapor-deposited bag / no desiccant, C2: aluminum vapor-deposited bag / silica gel, C3: aluminum vapor-deposited bag / desiccant sheet (3cm x 3cm), C4: aluminum vapor-deposited bag / desiccant sheet (6cm x 6cm), and D4: aluminum bag / desiccant sheet (6cm x 6cm), the combinations C4: aluminum vapor-deposited bag / desiccant sheet (6cm x 6cm) and D4: aluminum bag / desiccant sheet (6cm x 6cm) showed high enzyme activity.

[0075] As described above, the blood filter paper specimen package of this embodiment has an airtight storage section for storing the blood filter paper specimen and a dehumidifying means disposed in the storage section, making it possible to provide a blood filter paper specimen package in which the enzyme activity in the blood filter paper specimen is less likely to decrease even under high temperature and high humidity transport conditions.

[0076] Finally, the above-described embodiments are merely examples of the present invention, and the present invention is not limited to the above-described embodiments. Therefore, even if the above-described embodiments are different, various modifications can be made depending on the design, etc., as long as they do not deviate from the technical concept of the present invention. [Industrial Applicability]

[0077] According to the present disclosure, it is possible to provide a package in which the enzyme activity in a specimen is not likely to decrease even under high temperature and high humidity conditions. Furthermore, according to the present disclosure, it is possible to provide a method in which the enzyme activity in a specimen is not likely to decrease even under high temperature and high humidity conditions.

Claims

1. A blood filter paper specimen package having an airtight storage section for storing a blood filter paper specimen and a dehumidifying means disposed in the storage section.

2. The blood filter paper specimen package according to claim 1, characterized in that the dehumidifying means has the function of maintaining the humidity inside the storage section at any one of 70% or less, 60% or less, 50% or less, and 40% or less.

3. 2. The blood filter paper specimen package according to claim 1, wherein the dehumidifying means has a function of maintaining the humidity in the storage section at 10% or less.

4. 2. The blood filter paper sample package according to claim 1, wherein the container is a bag with a zipper.

5. 2. The blood filter paper specimen package according to claim 1, wherein the dehumidifying means is a desiccant.

6. A method for transporting blood filter paper samples, comprising storing and sealing the blood filter paper samples in a packaging body having an airtight storage section and a dehumidifying means disposed in the storage section, and transporting the blood filter paper samples.

7. A method for storing blood filter paper samples, comprising storing and sealing the blood filter paper samples in a packaging body having an airtight storage section and a dehumidifying means disposed in the storage section.

8. A package having an airtight storage section and a dehumidifying means disposed in the storage section is used as a blood filter paper specimen transporter for storing blood filter paper specimens and transporting them in a sealed state.

9. Use of a package having an airtight storage section and a dehumidifying means disposed in the storage section for storing and sealingly preserving blood filter paper specimens.

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