JP3475834B2 - Inspection methods and tools - Google Patents

Description

Detailed Description of the Invention

[0001]

The present invention relates to relates to a testing method and equipment therefor inspecting collected in checking center samples from a subject at a remote location.

Although a medical examination is carried out prior to the diagnosis of a disease, it is customary in the present medical examination method that the examinee goes directly to a hospital or a medical examination center and carries out the medical examination there. However, requesting the examinee to directly visit a hospital or a medical examination center in this manner causes a missed medical examination opportunity. Regarding urinalysis, a subject collects a sample in a specific container and collects the sample in a hospital or a medical examination center for medical examination.

However, in such a screening method, since the sample is transported in a liquid state, a general transportation method such as mail cannot be adopted, and the transportation is performed by a limited transportation means in a limited area. However, it was not possible to carry out a medical examination by wide-area transportation using a general transportation method. On the other hand, due to requests for specialized and efficient medical examinations, it is requested that specimens collected at hospitals be collected at specific examination centers and undergo intensive examinations, but liquid specimens such as urine and blood should be collected. Transporting large quantities causes accidents and is not desirable. In this case, there is a problem that a special container is used to transport the sample directly from the subject to the examination center and a special transportation means such as a postal package is required.

[0004]

The object of the present invention is to provide a, using simple tools, collect a sample can be safely packaged in a simple operation, inspection which was transported in a general way Se It is to provide an inspection method that can be inspected by collecting information in the center.

Another object of the present invention is to use in the above-mentioned examination method, and therefore, a sample can be collected and safely packaged by a simple operation using a simple tool. To provide an inspection tool that can be transported by a general means and collected at an inspection center.

[0006]

Means for Solving the Problems (1) A sampling unit including a sample holding sheet capable of holding a liquid sample,
And including a moisture absorbent to maintain the sample in a dry state by moisture absorption of moisture from the retained sample into the sample holding sheet, and includes a specimen bag capable of containing the sampling unit test
An inspection method using a 査 tools, deployed test device
Keep the sample collected by the subject on the sample holding sheet of
Hold the sampling unit in the sample storage bag,
By moisture absorption of moisture of the sample to the desiccant is conveyed to the checking center in the state where the sample is dried, the conveyed object holding sheet
An inspection method in which the retained sample is analyzed and tested at an inspection center . (2) The method according to (1) above, wherein the sampling unit has a structure in which both sides of the sample holding sheet are covered with protective covers. (3) The method according to (1) or (2) above, wherein the sample storage bag has a breathable diaphragm between the hygroscopic agent and the sampling unit storage space. (4) The method according to any one of (1) to (3) above, wherein the inspection tool includes an inspection sheet. (5) Distribute the checking center to the subject side, a sample collected in a subject side and held in the sample holding sheet, the sampling unit is accommodated in the sample accommodating bag, to moisture absorption of moisture of the sample to the desiccant Te an inspection tool for inspecting Shi feeding transportable specimens in a dry state, the sampling unit including the inner holdable object holding sheet specimen liquid, and absorbs moisture moisture from samples held on the sample holding sheet A testing tool including a sample storage bag which is provided with a hygroscopic agent for maintaining a sample in a dry state and which can store the sampling unit. (6) sampling unit both sides of the sample holding sheet is covered with a protective cover, inspection <br/> tool described (5), wherein the gripping portion is formed to have on hand at one end of the protective cover. (7) The sample storage bag is the inspection tool according to the above (5) or (6), wherein a hygroscopic agent is fixed to the bag by a breathable diaphragm.

The diseases to be tested in the present invention are not limited, and include all diseases which can be diagnosed by the results of the analysis of the dried sample transported. In particular, diabetes, gout, and phenylketonuria are included. Metabolic disorders such as inborn errors of metabolism are suitable as test targets.

[0008] The sample to be treated in the present invention is not limited, and any sample that can be easily collected and processed by the subject side such as urine, blood, and other body fluids is a target, but particularly, it is collected as a liquid such as urine. What is done is suitable as a target. Here, the examinee side can be identified with the examinee from the examination center, and the examinee's relatives, caregivers, caretakers, agents, doctors, nurses, hospitals, etc. In addition, it includes all persons who are in a position to collect, package, and return specimens for subjects.

In the present invention, the sampling unit includes a sample holding sheet. The sample holding sheet is urine,
In order to hold a liquid sample such as blood inside,
It is preferable to use a sheet such as paper or sponge which has voids inside and has little component elution. Particularly, a filter paper for analysis is preferable as a material having little deterioration and little elution component. The size of the sample holding sheet is set to a size required to hold the sample required for analysis. The shape is suitable for distribution and return, and is generally rectangular.

The sampling unit is preferably one in which both sides of the sample holding sheet are covered with protective covers. The protective cover is for improving the handling during sample collection, packaging, and transportation, and it can be used as a non-water-permeable one or a breathable one according to the purpose, but one side is liquid-impermeable. A sheet or film having a liquid permeability and a sheet or film having a liquid permeable and breathable surface on the other side are preferable. Further, it is preferable that the sampling unit has at least one end formed with a grip for holding by hand. Examples of the liquid-impermeable sheet or film include polyolefin such as polyethylene, polyester, and a joining sheet thereof. The breathable sheet or film is preferably a non-woven fabric or woven fabric made of the same material as described above.

[0011] The specimen bag is above the sampling unit, the housing while holding the specimen, held analyte
It is the sample water and moisture with a suction humectant you maintained in a dry state structure. In this case, it is preferable that the moisture absorbent and the sampling unit accommodating space have a water-permeable and air-permeable diaphragm. The diaphragm may be the same as the breathable sheet or film used for the protective cover of the sampling unit. The sampling unit is housed so that the water-permeable protective cover side faces the diaphragm side of the sample housing bag. The sample storage bag is preferably covered with a fixing means such as a double-sided adhesive tape. The hygroscopic agent is preferably one that does not react with the sample component, does not deteriorate the sample component, and simply absorbs or adsorbs only water, and a water-absorbing polymer such as sodium polyacrylate cross-linked resin is preferable.

The sample storage bag containing such a sampling unit can be sent to the inspection center as it is, but it is preferable to put it together with the inspection sheet in the transfer bag and transport it to the inspection center by mail or the like. As the inspection sheet, one that can record information such as the name, age, medical history and findings of a doctor is preferable, and it may be attached like a label or attached to a sampling unit like a tag. .

The inspection method of the present invention using the above-mentioned inspection tool is performed as follows. First, the sampling unit, the sample storage bag, and the attached inspection sheet, if necessary, are stored in the transport bag and distributed to the subject side together with the instructions.
These distributions may be carried out individually for each subject, or may be carried out through an organization such as a hospital or clinic.

On the subject side, the subject himself or a hospital or the like collects a specimen by collecting urine. In the case of collecting urine, for example, in the case of collecting urine, in addition to the method of sampling in a sampling unit after collecting urine in a paper cup or the like, it can be excreted directly in the sampling unit for sampling. In either case, by grasping the grasping portion, it is possible to prevent contamination of the hand or the instrument and efficiently sample.

If the sampled sampling unit is left as it is, bacteria and mold may adhere to the sampled unit to reproduce and deteriorate, so that the sampled unit is quickly stored in a sample storage bag. In this case, the sampling unit is housed in the sampling unit housing space with the breathable protective cover facing the diaphragm of the sample housing bag, and the lid is closed.

In the sample-holding bag, the moisture held by the sample-holding sheet permeates through the water-permeable protective cover and the diaphragm, is absorbed by the hygroscopic agent, and is in a dry state. In the dry state, the quality of the retained body fluid component does not change and it does not contaminate other articles. For this reason, it is possible to carry it as it is or by putting it in a carrying bag by a general carrying means such as ordinary mail.

At the inspection center, the sampling unit conveyed from the subject side is taken out, mounted on the column, and then distilled water is added to the sample holding sheet to elute the sample components to prepare a sample and the inspection is performed. At this time, the amount of the sample held on the sample holding sheet is different, but it is related to the amount of the sample by obtaining the composition of each component based on the amount of creatinine in the reference component, such as creatinine, which is always contained in the sample Without it, a chemical test can be performed.

[0018]

According to the present invention, a sampling unit including a sample holding sheet capable of holding a liquid sample, and a hygroscopic agent for absorbing moisture from the sample held on the sample holding sheet to maintain the sample in a dry state And, a test tool including a sample storage bag capable of storing the sampling unit, distributed from the test center to the subject side, in a state of holding the sample collected on the subject side on the sample holding sheet,
The sampling unit was accommodated in the sample accommodating bag, by moisture absorption of moisture of the sample to the desiccant is transported to the inspection cell <br/> centers in a state in which the sample is dried, held in the conveyed object holding sheet at the checking center Since the sample was analyzed and tested , the sample was collected by a simple operation using a simple tool and stored in the sample storage bag, and the moisture of the sample was absorbed by the hygroscopic agent to dry the sample. In this state, it can be safely packaged without being altered or contaminated, and it can be transported by general means and collected at an inspection center for easy inspection .

[0019]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to the drawings. 1 (a) to 1 (c) are front views showing a sampling unit, a sample storage bag, and a transport bag of an inspection tool according to an embodiment, and FIGS. 2 (a) to 2 (c) are AA and B of FIG. -B, CC sectional drawing, FIG.3 (a) is a perspective view which shows a use condition, (b) is a front view which shows the inspection tool of other embodiment, FIG.4 is a flowchart of an inspection method.

In FIGS. 1 and 2, reference numeral 1 in (a) is a sampling unit, which is a protective sheet made of a transparent, water-impermeable, breathable plastic sheet on one side (front side) of a sample holding sheet 2 made of filter paper. A protective film 4 made of a water-permeable and breathable plastic nonwoven fabric is laminated on the film 3 and the opposite (back) surface, and heat-sealed at a joint portion 5. The specimen holding sheet 2 and the protective films 3 and 4 are in a peeled state except for the joint portion 5. The protective films 3 and 4 further extend from the joint portion 5 and a joint portion 6 is formed at the tip end portion by heat sealing, and a joint portion 7 is also formed at the opposite end portion by heat sealing. There is no sample holding sheet 2 between the joints 5 and 6,
It is a grip portion 8.

The sample storage bag 11 of (b) is made of a transparent and water-impermeable front side sheet 12 and a back side sheet 13 made of a water-permeable and breathable plastic non-woven fabric so that the moisture absorbent sheet 14 is sandwiched between the back side sheet 13 and the back side sheet 13. Together with the diaphragm 15, the bottom and side joints 16 are heat-sealed together to form a bag having a sampling unit housing space 17. The back sheet 13 and the diaphragm 15 are also joined by heat sealing at the joint 16a formed on the upper portion, and the back sheet 13 extending further from this portion is folded back at the joint 16a to form the lid 18. There is. A fixing material 19 such as a double-sided adhesive tape is attached to the upper end portion of the front sheet 12, and a release sheet is pasted in a state before use to prevent the lid 18 from being fixed.

The carrying bag 21 of (c) is formed into a bag by joining a water-impermeable, non-air-permeable plastic tube 22 having a size capable of accommodating the sample collection bag 11 at the joint portion 24 by heat sealing. A fastener 25 is provided in the opening so that it can be opened and closed.

An inspection method using the above-mentioned inspection tool is performed as follows, as shown in FIG. First, in a state where the sampling unit 1, the sample storage bag 11 and the inspection sheet (not shown) attached as necessary are stored in the transportation bag 21, the inspection center 31 is transported to the subject side 32 for distribution along with the instruction manual. To do.

On the subject side 32, the subject himself or a hospital or the like collects a specimen by collecting urine or the like. In the case of collecting urine, for example, in the case of collecting urine, in addition to the method of sampling in the sampling unit 1 after collecting urine in a paper cup or the like, it is also possible to directly excrete into the sampling unit for sampling. In any case, as shown in FIG. 3A, the grip portion 8 of the sampling unit 1 is gripped by one hand 9, and the other joint portion 7 is moved in the direction of arrow a to move the specimen holding sheet. By exposing 2 the contamination of hands and instruments can be prevented and the sample collection 33 can be performed efficiently.

Sampling unit 1 sampled
If left undisturbed, bacteria and fungi may attach and reproduce and change in quality, so it should be stored in the sample storage bag quickly. In this case, the droplets are cut, and the breathable protective film 4 is directly directed to the diaphragm 15 of the sample storage bag 11 without drying the sampling unit, and stored in the sampling unit storage space 17, and the lid 18 is folded back and closed. . Then, the release paper (not shown) attached to the double-sided adhesive tape of the fixing material 19 is peeled off, and the lid 18 is pressed against the fixing material 19 so as to be fixed and sealed.

In the sample storage bag 11 containing the sampling unit 1 as described above, the protective film 4 and the diaphragm 1 which allow water to pass from the sample held on the sample holding sheet 2 are passed.
5 permeates through 5 and is absorbed by the hygroscopic agent 14 to be in a dry state. In the dry state, the quality of the sample components does not change, and it does not contaminate other articles. Therefore, in this state, by putting the sample container 11 in the transport bag 21 and sealing it with the fastener 25, it is possible to carry out the packaging 34 and transport by a general transport means such as ordinary mail.

At the inspection center 31, the sampling unit 1 conveyed from the subject side 32 is taken out, mounted on a column, distilled water is added to the sample holding sheet 2 to elute the sample components, and the sample is prepared. Perform an inspection . At this time, the amount of the sample held in the sample holding sheet 2 is different, but by obtaining the composition of each component based on the amount of creatinine in a reference component, such as creatinine, which is always contained in the sample in a fixed amount,
Chemical tests can be performed regardless of the amount of sample.

Distribution and collection of the above-described inspection tool may be carried out directly on the individual subject, or may be carried out through an organization such as a hospital or clinic. All of these are included in the subject side 32. In any case, when the sample is collected 33, the sample can be collected simply by holding the sampling unit 1 by hand, and the sample can be collected easily without soiling the hands. In this case, it is difficult to dry the sample. No operation is required, and the sample can be dried simply by packaging after collection. Since the sample is transported in such a dry state, there is no possibility that the sample will be altered or other substances will be contaminated.

Therefore, the specimens can be collected at the examination center by a simple transporting means such as ordinary mail, and the examination can be conducted intensively and precisely. This makes it possible to perform an efficient test, and by facilitating the test operation, it is possible to broaden the opportunity to participate in the test and to help prevent disease.

FIG. 3B shows a sampling unit for a subject who uses a diaper such as an infant, and protective films 3 and 4 made of a liquid-permeable and breathable nonwoven fabric are provided on both sides of the sample holding sheet 2. They are arranged, and the joint portion 6 is formed on the periphery thereof. This sampling unit 1 is also used in the same manner as described above.

[Brief description of drawings]

FIG. 1 shows an inspection tool according to an embodiment, (a) is a front view of a sampling unit, (b) is a front view of a sample storage bag,
(C) is a front view of the carrying bag.

2A is a sectional view taken along line AA of FIG. 1, and FIG. 2B is taken along line BB.
Sectional drawing, (c) is CC sectional drawing.

FIG. 3A is a perspective view showing a usage state, and FIG. 3B is a front view showing an inspection tool of another embodiment.

FIG. 4 is a flow chart of an inspection method.

[Explanation of symbols]

1 Sampling Unit 2 Specimen Holding Sheet 3, 4 Protective Film 5, 6, 7, 16, 16a, 24 Bonding Part 8 Grip Part 9 Hand 11 Specimen Storage Bag 12 Front Side Sheet 13 Backside Sheet 14 Hygroscopic Agent Sheet 15 Septum 17 Sampling Unit Storage Space 18 Lid 19 Adhesive 21 Transport bag 22 Plastic tube 25 Fastener 31 Inspection center 32 Subject side 33 Sample collection 34 Packaging

─────────────────────────────────────────────────── ─── Continuation of the front page (58) Fields surveyed (Int.Cl. ⁷ , DB name) G01N 33/48-33/98 G01N 1/00-1/34

Claims (7)

(57) [Claims] 1. A sampling unit including a sample holding sheet capable of holding a liquid sample, and a hygroscopic agent for absorbing moisture from the sample held by the sample holding sheet to maintain the sample in a dry state, and the sampling test method using a test device comprising a housing capable specimen bag units
A is, subject side smell specimen holding sheet of deployed test device
Holding the specimen collection Te, holding the sampling unit is accommodated in the sample accommodating bag, by moisture absorption of moisture of the sample to the desiccant is conveyed to the checking center in the state where the sample is dried, the conveyed object holding sheet The tested sample
Inspection method for inspecting and analyzing the terpolymer. 2. The method according to claim 1, wherein the sampling unit has a structure in which both sides of the sample holding sheet are covered with protective covers. 3. The method according to claim 1, wherein the sample storage bag has a breathable diaphragm between the hygroscopic agent and the sampling unit storage space. 4. The method according to claim 1, wherein the inspection tool includes an inspection sheet. 5. The test center distributes the sample to the subject side, and the sample collected by the subject side is held on a sample holding sheet.
Te, the sampling unit is accommodated in the sample accommodating bag, by moisture absorption of moisture of the sample in the moisture absorbent Shi feeding transportable specimens in a dry state detection
A test device for performing 査, maintaining the sampling unit including the inner holdable object holding sheet specimen liquid, and the sample was hygroscopic moisture from retained analyte in the sample holding sheet in a dry state moisture absorption An inspection tool including a sample storage bag that is provided with an agent and can store the sampling unit. 6. The sampling unit according to claim 5, wherein both sides of the sample holding sheet are covered with protective covers, and a grip portion for holding by hand is formed at one end of the protective cover.
Inspection tool. 7. The testing tool according to claim 5, wherein the sample storage bag has a hygroscopic agent fixed to the bag with a breathable diaphragm.