JP5231106B2 - Sample testing tool - Google Patents

Description

  The present invention is based on dipsticks, test strips, more specifically immunochromatography or nucleic acid chromatography, and in the fields of infectious diseases, myocardial markers, hormones, tumor markers, various allergies, drugs, coagulation / fibrinolysis, etc. The present invention also relates to a strip-like specimen testing tool for testing and testing used for testing various antigens, antibodies and nucleic acids.

  The above-described specimen testing tool is based on an immunochromatography method based on the antigen-antibody reaction that has been mainly used for the detection of influenza viruses, RSV, chlamydia, O157, etc. Known as a detection kit together with a tube (see, for example, “Medical and Testing Instruments / Reagents 28 (3), 2005”, pages 211 to 214 (published by Lab Service in June 2005)) ing.

  This is because the specimen containing the test object such as influenza virus and RSV and the test liquid such as the developing solution are collected in a test tube or extraction container having a diameter larger than the width of the strip-shaped test apparatus for test and inspection. In addition, by inserting a strip-shaped inspection device for test inspection into a test tube or an extraction container in which the inspection liquid is accumulated, the inspection liquid is developed in the strip-shaped inspection device for test inspection by capillary action. Test method.

  That is, as shown in FIG. 4, the conventionally used specimen testing tool 11 has a specimen liquid display section 13 in which a test line 13 a and a control line 13 b are formed on the surface of an elongated backing sheet 12. The conjugate pad part 14 and the sample liquid collecting part 15 are continuously polymerized over the length direction of the backing sheet 12 on the other side, and the conjugate pad part 14 and the specimen liquid collecting part 15 are on the other side. Has been.

Also, when measuring allergens that cause bronchial sighs, allergic rhinitis, atopic dermatitis, etc. from the test object, the specimen collection part is made removable and the specimen is collected at another place and used as a test instrument. There is also known an analyzer for immunochromatography which is designed to be mounted (see Japanese Patent Application Laid-Open No. 2005-17248).
"Medical and Testing Equipment / Reagents 28 (3), 2005", pp. 211-214 (published in June 2005, Lab Service) JP 2005-17248 A

  In general, the sample extraction tube has a special shape that is easy to handle by crushing to extract a large amount of the test object from the sample collected with a cotton swab etc. into the developing solution, etc., and has been inserted into the sample extraction tube so far This has been dealt with by changing the shape of the tube for sample extraction in accordance with the strip-shaped inspection tool for test inspection.

  The strip-shaped test tool described above generally has a test liquid introduction section (collecting section) for introducing a test liquid such as a specimen and a developing liquid into the test apparatus on one end side in the long axis direction. The analyte reaction solution is wetted toward the absorption portion at the other end through the subsequent conjugate pad portion and the developing portion, and the detection target object moves (deploys).

  However, in recent years, the application range of strip-type inspection devices for testing has expanded to genetic testing. In genetic testing, nucleic acid is used as a test material, and detection using a nucleic acid amplification technique such as the PCR method or NASBA method is possible with higher sensitivity than immunochromatography, which detects the test object by antigen-antibody reaction. The expansion of the application range of strip-type testing equipment for testing and testing to genetic testing has led to dramatic improvements in detection sensitivity and high detection sensitivity for strip-type testing equipment for testing and testing that has simple operability. The versatility of genetic testing with

  However, since genetic testing is highly sensitive, the possibility of contamination is increased, and in order to introduce a nucleic acid amplification reaction solution obtained by amplifying the nucleic acid of the test object into a strip-type testing device for testing and testing, Moving to a tube wider than the width of the inspection apparatus has a risk of expanding the contamination of the amplification product, and also reduces the reliability of the inspection result.

  In addition, when the nucleic acid of the test object is amplified by the PCR method or NASBA method, the volume of the nucleic acid amplification reaction solution is small, so the tube at the time of amplification is also small, and the reaction efficiency and the recovery rate of the reaction solution for nucleic acid amplification production In view of the above, an inverted cone-like tube whose diameter decreases toward the bottom is used. Since the PCR method uses special equipment such as a thermal circular, many small amplification tubes are used.

  Therefore, as shown in FIG. 2, the application range of the widely used strip-shaped specimen inspection tool 11 is to collect the specimen extraction tube for immunochromatography [FIGS. 2A and 2B], and the specimen and the developing solution. Not only test tubes [Fig. 2 (C)] but also small tubes with cap C: up to 0.5 ml capacity [Fig. 2 (D)] and 0.2 ml capacity [Fig. 2 (E)] It was expanded to.

  In this case, when the general-purpose strip-shaped specimen testing tool 11 is used for, for example, the specimen extraction tube T1 for immunochromatography (FIG. 2A), the specimen liquid collecting section 15 is large because the inner diameter near the inner bottom of the tube T1 is large. Can sufficiently touch the sample liquid sample S (see FIG. 5A), whereas in the nucleic acid amplification tube T4, the tip of the sample liquid collecting section 15 is difficult to touch the sample liquid sample S. Moreover, the sample liquid sample S does not reach the nucleic acid amplification tube T5 [FIG. 2E] (see FIG. 5B).

  In other words, when inserting a strip-shaped inspection device for test inspection directly into an amplification tube used in PCR method etc., the test liquid introduction part does not reach from the shape of the strip-shaped inspection device for test inspection to the bottom of the amplification tube, Further, since the amount of the nucleic acid amplification reaction solution is small, it cannot be applied to a conventional strip-type inspection apparatus for test inspection. This is because the tip of the sample fluid collecting unit 15 is backed by the backing sheet 12, and the tip of the sample fluid collecting unit 15 is not flexible.

  In this case, in order to match the shape of the amplification tube used in the PCR method, etc., it may be possible to narrow the tip width of the strip-shaped inspection tool for test inspection to match the inner bottom of the amplification tube. In some cases, the visibility deteriorates, and the usefulness of the strip-shaped inspection tool for test inspection becomes poor.

  In addition, when the inspection sampling part is made detachable as in Patent Document 1, there is a possibility of contamination due to attachment / detachment, and when a small amount of inspection liquid is collected, there is a sufficient inspection object for detection due to loss in the gap of the joint part. In particular, since the amount of gene amplification reaction solution is small, a slight loss of the reaction solution results in a significant decrease in the performance of the strip-like test tool for testing.

  Therefore, the present invention has been developed in view of the above-described conventional problems and actual conditions, and is excellent in handling and operability. In particular, the principle is not only a sample extraction tube for immunochromatography by an immunochromatography method but also nucleic acid chromatography. This has led to the development of a specimen testing tool that can be applied regardless of the type of tubing for sample collection, up to a small nucleic acid amplification tube that is not particularly limited, such as a sandwich method or an inhibition method.

Specifically, an elongated backing sheet, and a conjugate pad part, a specimen liquid collecting part, and an absorption pad part that are continuously polymerized over the length direction across the specimen liquid display part on the surface of the backing sheet consists of a, the sample fluid collecting portion has a water absorption property and made of a flexible material having the flexibility to deform to fit the shape of the specimen container, yet some of the length of the backing sheet of its Projecting from the end in the direction , and inserted into the sample container from the partial side to collect the sample liquid, and the thickness of the sample liquid collecting part is formed to be smaller than the thickness of the backing sheet , The present invention relates to a sample testing tool characterized by being easily deformed in accordance with the shape in the sample container when inserted into the sample container from a part .

The specimen testing tool for a strip-like test test according to the present invention uses a flexible material having a water absorption property at the tip of the specimen liquid collecting portion and a flexibility that can be deformed in accordance with the shape in the specimen container. , yet a part of its protrudes from lengthwise end portions of the backing sheet, and is formed thinner than the thickness of the backing sheet thickness of the sample liquid collecting section, tubes of immunochromatographic specimen for extraction tube and various in as well, in order to be able to parts that are not backed by the backing sheet of the sample fluid collecting part is flexibly curved or bent to conform to the shape of the inner diameter and the inner bottom of the tube, particularly to small sample container such as a nucleic acid amplification tubes It can be applied and can be used regardless of the type, shape, and size of the tube that stores the test solution such as the sample, the developing solution, and the sample extract. Can.

  In addition, since it is not necessary to remove the sample liquid sampling part at the tip unlike conventional products, tests and inspections can be performed with a small amount of test liquid, especially transfer of test liquid and introduction of test liquid into the test equipment. Highly accurate testing and testing is possible in the genetic testing area where the possibility of contamination is increased due to, etc., and exhibits excellent practicality. In addition, from a test that depends on the tube shape in the conventional inspection, the test can be performed with a small amount of a test solution that does not depend on the tube shape, and can be used for a wide variety of applications.

  The contents of the present invention will be described below based on the embodiment shown in FIG. In the figure, reference numeral 1 denotes a specimen testing tool according to the present invention, and the specimen testing tool 1 includes an elongated backing sheet 2, a specimen liquid display section 3, a conjugate pad section 4, a specimen liquid collection section 5, and an absorption pad. It is comprised from the part 6. Specifically, the conjugate pad portion 4 and the sample liquid collection in the distal direction with the elongated backing sheet 2 and the surface of the backing sheet 2 sandwiching the sample liquid display portion 3 positioned substantially at the center in the length direction. On the opposite side of the part 5 and the specimen liquid display part 3, an absorption pad part 6 is continuously polymerized in the base direction.

  In other words, on the surface of the elongated backing sheet 2, there is a sample liquid collecting section 5 for introducing a test liquid such as a sample and a developing liquid into the test apparatus on one end side in the length direction, and a conjugate pad section following this. 4. It has a structure in which the sample reaction solution is wetted toward the absorption pad unit 6 at the other end via the sample solution display unit 3 and the detection target is moved (developed).

  The backing sheet 2 is made of a material having a certain degree of tension, such as a thin plastic plate that has been conventionally used, and usually has a width of about 3 mm to 8 mm and a length of about 40 mm to 100 mm. The conjugate pad section 4 is impregnated with a label (labeled antigen, labeled antibody, or labeled nucleic acid) for the target substance (antibody, antigen, or nucleic acid) to be detected, and the sample collected by the sample liquid collecting section 5 The object to be detected accompanying the infiltration of the liquid moves / combines, and subsequently moves to the specimen liquid display unit 3 along with the infiltration.

  In addition, the specimen liquid display unit 3 has another antigen, antibody, or nucleic acid that reacts with the target substance to be detected immobilized as a test line 3a, and binds to a label (labeled antibody, labeled antigen, or labeled nucleic acid). It reacts with the target product (sandwich method) and colors. The label that has not been bound to the target substance further moves due to infiltration, and is colored on the control line 3b on which the antibody or nucleic acid that binds to and captures the label is solid-phased.

  The absorption pad section 6 is for absorbing the sample that has passed through the sample liquid display section 3, and a known material can be used. Further, the present invention is characterized in that the sample liquid collecting part 5 is made of a water-absorbing flexible material, and at least a part of the sample liquid collecting part 5 protrudes from the end in the length direction of the backing sheet 1.

  For the water-absorbing flexible material constituting the sample liquid collecting unit 5, for example, a porous water-absorbing material such as PVDF, nitrocellulose, nylon, CMF, or non-woven fabric, which is tested in a state immersed in the test liquid. Therefore, it is desired to have a durability that does not easily drop off from the strip-shaped inspection tool 1 and a strength that can maintain a shape retaining property that does not bend in a state where it is not immersed in the inspection liquid (free state).

  In this case, if the strength is too high, the tube cannot be deformed according to the inner bottom shape of the tube. Therefore, when it is in contact with the inner wall surface of the tube, it is necessary to have flexibility that can be easily deformed according to the inner wall shape. is there. In addition, if the thickness of the sample fluid collecting unit 5 is too large, it takes too much time for the test solution to reach the sample fluid display unit 3 and the absorption pad unit 6 via the conjugate pad unit 4 from the test solution collecting unit 5. A material that exhibits high water absorption even when thin is desirable, and a nonwoven fabric is preferable.

  Most of the strip-shaped test tool 1 for test and testing is lined with a backing sheet 2 made of a plastic substrate, and at least the tip of the water-absorbing flexible material constituting the sample fluid collecting unit 5 is formed in a tube shape. In order to deform in accordance with the above, it is necessary to project at least the front end portion ahead of the end portion in the length direction of the backing sheet 2 described above. In that case, for example, in the case of a strip-shaped inspection tool 1 having a width of 4 mm, if it is less than 2 mm, deformation becomes difficult, and conversely, if it exceeds 40 mm, it is difficult to maintain sufficient shape retention in a free state, It needs to be in the range of 2 mm to 40 mm, more preferably in the range of 5 mm to 35 mm.

  When a test tool was inserted into a 0.2 mL microtube of a strip-shaped conventional test tool having a width of 4 mm, the test specimen was not able to reach the bottom of the microtube. On the other hand, in order to produce a strip-like specimen test tool 1 of the present invention having the same width and width, a non-woven fabric is used as a water-absorbing flexible material constituting the sample liquid collecting section 5 and the tip thereof is attached to the above-described end. A test specimen 1 in the form of a strip for test inspection was produced by projecting 7 mm ahead of the lengthwise end of the backing sheet 2.

  When this was inserted into a small nucleic acid amplification microtube T5 having a capacity of 0.2 mL as shown in FIG. 3A and used for collecting / inspecting the sample S, the tip of the sample liquid collecting unit 5 was obtained. After abutting the inner wall surface of the tube T5, the tip 5a is bent slightly along the inner wall surface, and the tip is curved along the inner wall near the narrow inner bottom portion (see FIG. 3B). The specimen sample S near the narrower inner bottom could be sufficiently immersed.

  Thereafter, the absorbed specimen sample S passes through the conjugate pad section 4 impregnated with a labeling object (labeled antigen, labeled antibody, or labeled nucleic acid) for the target substance (antibody, antigen, or nucleic acid) to be detected, and the specimen liquid display section 3 After passing through the control line 3b in which the antibody or nucleic acid bound to the target substance binding test line 3a and the labeled substance and captured thereon are solid-phased and colored, the absorbent pad portion 6 is smoothly moved by wetting. Was confirmed.

BRIEF DESCRIPTION OF THE DRAWINGS The top view (A), exploded side view (B), and side view (C) of the sample test tool which is one Example of this invention. The side view of various tubes which can apply the sample test | inspection tool of this invention. The perspective view (A) showing the use condition of the sample test | inspection tool of this invention, and the partial perspective view (B) showing the deformation | transformation state of the front-end | tip part of the sample liquid collection part in a tube from the back side. The top view (A) and side view (B) of the conventional specimen test tool. The side view showing the state inserted in each of the sample extraction tube (A) for immunochromatography using the conventional sample test tool, and the tube for nucleic acid amplification (B) of a 0.2 ml capacity | capacitance.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Specimen inspection tool 2 Backing sheet 3 Specimen liquid display part 3a Test line 3b Control line 4 Conjugate pad part 5 Specimen liquid collection part 5a Tip part of specimen liquid collection part 6 Absorption pad part

Claims (5)

An elongated backing sheet, and a conjugate pad part, a specimen liquid collecting part, and an absorption pad part that are continuously polymerized over the length direction across the specimen liquid display part on the surface of the backing sheet,
The sample fluid collecting portion has a water absorption property and made of a flexible material having the flexibility to deform to fit the shape of the specimen container, yet from lengthwise end portions of some of said backing sheet of its Protrudes and is inserted into the sample container from the partial side to collect the sample liquid,
The specimen testing tool, wherein the specimen liquid collecting part is formed thinner than the backing sheet . The specimen testing tool according to claim 1, wherein the water-absorbing flexible material constituting the specimen liquid collecting part is a nonwoven fabric. Analyte test device of claim 1 where the water-absorbing flexible material constituting the sample fluid collecting part is PVDF or nylon. The width of the sample fluid collecting part, in a range of 3 mm to 8 mm, the portion of the projecting length projecting from longitudinal ends of the backing sheet is in place in the range of 2mm~40mm The specimen testing tool according to any one of claims 1 to 3. In a range of width of the sample fluid collecting part is 3 mm to 8 mm, the portion of the projecting length projecting from longitudinal ends of the backing sheet, wherein where in the range of 5mm~35mm Item 4. The specimen testing tool according to any one of Items 1 to 3.

Images