JP2008032586A - Holding sheet body for stick-like clinical examination tool - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a holding sheet body for a stick-like clinical examination tool having excellent handling operability, and having no possibility of secondary infection. <P>SOLUTION: In this holding sheet body for the stick-like clinical examination tool, a pressure sensitive adhesive layer is equipped with an examination tool fixing part coated with mold releasing paper. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a holding sheet for a stick-shaped clinical test tool, more specifically, based on an immunochromatography method, in the fields of infection, myocardial marker, hormone, tumor marker, allergy, drug, coagulation / fibrinolysis, and the like. Holding sheet body for stationaryly fixing the stick-shaped clinical test tool until the test result is obtained after the sample liquid is absorbed in the stick-shaped clinical test tool used for testing for antigens and antibodies About.

  Conventionally, the above-described stick-shaped clinical examination tool is generally put into practical use as a detection kit together with a specimen extract or a cotton swab or a test tube (for example, see Non-Patent Document 1).

  However, when a test is conventionally performed using the detection kit, the stick-type clinical test tool is left in the test tube containing the sample liquid or placed in an appropriate place until the test result is obtained. I was only there. For this reason, there is a problem that the stick-shaped clinical test tool cannot be stably held, and there is a risk of secondary infection particularly in the case of an infectious disease sample. In addition, it was actually difficult to store test results using the stick-shaped clinical test tool.

  In addition, when placed on paper, the sample liquid absorbed in the specimen holding part of the stick-shaped clinical test tool oozes out to the opposite side of the placed paper. In the case of these specimens, there was a problem that there was a risk of secondary infection.

Furthermore, in the past, the stick-type clinical test tool was originally placed and fixed in a desired position, the test result was easily judged, the test result (patient) was prevented from being confused, and the secondary infection was excellently preserved. The actual situation was that there was no container.
"Medical and Testing Equipment / Reagents 28 (3), 2005", pages 211-214 (published in June 2005, Lab Service)

  The present invention has been made in view of the above-described conventional problems and situations, and is excellent in handling operability, has no confusion with test results (patients), and has no fear of secondary infection. It is an object to provide a holding sheet body.

  In order to solve the above-mentioned problem, the holding sheet body for a stick-shaped clinical test tool of the present invention according to claim 1 is provided with a test tool fixing part in which an adhesive layer is covered with a release paper. .

  With such a configuration, the stick-shaped clinical test tool can be fixed more easily and reliably by simply peeling the release paper and attaching the stick-type clinical test tool to the exposed adhesive layer. Can be held.

  Moreover, the holding sheet body for a stick-shaped clinical test instrument of the present invention according to claim 2 is characterized in that the holding sheet body is made of a laminate material of a mount, an adhesive layer, and a transparent water-impermeable film. Yes.

  With such a configuration, it is possible to prevent the specimen from seeping out to the opposite surface of the holding sheet body, so there is no risk of secondary infection.

  Moreover, the holding sheet body for a stick-shaped clinical test tool of the present invention according to claim 3 is such that the test tool fixing part has a window hole part formed on the mount and a transparent water-impermeable material exposed from the window hole part. It is characterized by comprising release paper that covers the adhesive layer on the film.

  With such a configuration, since the stick-shaped clinical test tool is attached to the concave portion corresponding to the thickness of the mount formed by peeling the release paper, the stick-shaped clinical test tool can be fixed and held more stably. .

  The holding sheet body for a stick-shaped clinical test instrument according to the present invention according to claim 4 is such that the holding sheet body covers at least the stick-shaped clinical test tool adhered to the test tool fixing part with a transparent water-impermeable film. It is characterized by having a bent piece portion for sealing.

  With such a configuration, the stick-shaped clinical examination tool adhered to the pressure-sensitive adhesive layer can be sealed as a whole, so there is no risk of secondary infection.

  Further, in the holding sheet body for a stick-shaped clinical test instrument of the present invention according to claim 5, the bent piece portion is composed of a transparent water-impermeable film, an adhesive layer, and a release paper covering the same. It is a feature.

  With such a configuration, it is possible to seal the stick-shaped clinical examination tool so as to be observable from the outside with the exposed transparent water-impermeable film only by peeling the release paper.

  The holding sheet for a stick-shaped clinical test tool according to the present invention according to claim 6 displays the pattern sample of the stick-shaped clinical test tool in parallel with the test tool fixing part on the mount surface or the transparent water-impermeable film surface. It is characterized by being.

  With such a configuration, the stick-shaped clinical test tool can be more easily and reliably attached to a predetermined place in a predetermined direction using the pattern sample as an index.

  Further, the holding sheet for a stick-shaped clinical examination tool of the present invention according to claim 7 is characterized in that a determination reference mark is displayed on the mount surface or the transparent water-impermeable film surface.

  With such a configuration, it is possible to easily and reliably determine the result by comparing the determination reference mark with the reaction mark appearing in the determination window of the clinically-tested instrument that is stuck and fixed. In particular, when there is a possibility that a plurality of marks appear in the determination window as in the example described later, it is possible to prevent the result from being misidentified.

  Moreover, the holding sheet body for a stick-shaped clinical test instrument of the present invention according to claim 8 is characterized in that a date and name entry column is provided on the mount surface or the transparent water-impermeable film surface.

  With such a configuration, since the date of the examination and the name of the patient can be entered, it is possible to prevent confusion between the examination results (patient).

  Since the holding sheet body for the stick-shaped clinical examination tool of the present invention is excellent in handling operability and safety, it is very easy and reliable to test for infectious diseases without fear of secondary infection. Can be performed. Specifically, for example, HBs antigen, HBs antibody, HCV antibody, HIV antibody, rotavirus antigen, influenza virus antigen, norovirus antigen, adenovirus antigen, rubella antibody, RS virus antibody, proboscis virus antibody, chlamydia antibody, mycoplasma antibody, It can be applied to stick-type clinical examination tools used for examination of pneumococcal antigen, group A streptococcal antigen, tuberculosis antigen, legionella antigen, E. coli verotoxin, E. coli O157, Helicobacter pylori antibody, syphilis TP antibody, malaria antibody and the like.

  As the mount of the present invention, a laminate having both sides laminated is preferably used in order to improve curl resistance. Further, the part other than the release paper to be peeled may be inseparably integrated with the transparent water-impermeable film by the pressure-sensitive adhesive layer, but only in the part covered with the release paper, the release paper is matched to the shape. Since it is cumbersome to insert the sheet, it is preferable that the mount itself is made of release paper used for general labels, seals, and the like. Further, as described above, it is preferable that processing is performed so that the sample does not infiltrate from the sample liquid holding part of the stick-shaped clinical test tool, and a known method can be used as the processing method. As an example of the mount, white polylamicraft or the like can be cited.

  As the transparent water-impermeable film, polyolefin materials such as polyethylene (PE) and polypropylene (PP) and polyethylene terephthalate (PET) can be used. Among them, transparent PET is weather resistant, heat resistant, transparent, and volatile organic. This is preferable from the viewpoint of a small amount of substances.

  As the pressure-sensitive adhesive, rubber-based, acrylic-based, vinyl ether-based emulsions and various solvent-based or solvent-free pressure-sensitive adhesives can be used, but solvent-based pressure-sensitive adhesives excellent in chemical resistance and water whitening resistance are preferably used. It is done.

As a production method of the holding sheet body of the present invention, for example, it can be produced in the same manner as in the production process of general labels and stickers. More specifically, it can be created through the following steps, for example.
After the pressure sensitive adhesive is applied to the release paper with a coater, the pressure sensitive adhesive is fixed with a drier, and a PET film is bonded to the surface coated with the pressure sensitive adhesive, and then cut to an appropriate printing size. Next, a desired design is printed on the release paper surface opposite to the surface on which the PET film is bonded, and a mat varnish is printed thereon. After that, using a punching die with different blade lengths that can be fully punched and half punched at once, it is punched with a punching die according to the printing surface. Here, full extraction is to cut the three layers of release paper, adhesive, and film in order to extract the shape of the required product from the printed material, and half extraction is to cut only the release paper. That is.
Also, instead of printing the desired design on the release paper surface opposite to the surface on which the PET film is bonded as described above, the desired design is printed on the release paper surface on the surface on which the PET film is bonded. It is also possible to print a desired design on the surface of the PET film to be bonded (either on the adhesive side or on the opposite side).

The stick-type clinical test tool to which the holding sheet for the stick-type clinical test tool of the present invention is applied is not particularly limited as long as it is based on the immunochromatography method, but the sandwich method or the inhibition method is not particularly limited. It is preferable that it is a stick-shaped stick. The stick generally has a structure in which a sample dropping portion is provided on one end side in the long axis direction, and the sample solution infiltrates toward the absorption portion at the other end through the conjugate pad portion and the developing portion. Have. The conjugate pad is impregnated with a labeled antibody against the target antigen to be detected, and the antigen and the labeled antibody are bound to infiltrate into the subsequent developed portion as the sample solution infiltrates. Another antibody against the target substance to be detected is immobilized on the development part as a test line, and reacts with the antigen bound to the labeled antibody and is colored (sandwich method). The labeled antibody that has not bound to the antigen further infiltrates and is colored on the control line on which the antibody against the labeled antibody is immobilized.
As a result, when there is a detection target in the sample, the test line and the control line are colored, and when there is no target object, only the control line is colored.

  Hereinafter, as an example of an embodiment of the present invention, a case of a holding sheet of a stick-type clinical test tool for detecting influenza A virus antigen or influenza B virus antigen will be described with reference to FIGS.

  1 to 4, A is a holding sheet for a stick-shaped clinical test instrument of the present invention, and is composed of a laminate of a mount 10, an adhesive layer 30, and a transparent water-impermeable film 20.

  Reference numeral 40 denotes a test tool fixing unit for fixing and holding the stick-shaped clinical test tool B. The inspection tool fixing unit 40 includes a window hole 11 formed in the mount 10 and a release paper 12 that covers the adhesive layer 30 of the transparent water-impermeable film 20 exposed from the window hole 11. ing. In addition, it is more desirable from the viewpoint of sticking and fixing operability that the window hole portion 11 is formed slightly larger than the outer shape of the stick-shaped clinical test tool B. Specifically, when the stick-shaped clinical test tool B is fixed at a desired position, it is preferable that there is a margin of about 0.05 to 4 mm, preferably about 0.1 to 2 mm in the vertical and horizontal directions.

  Reference numeral 50 denotes a bent piece for covering and sealing the stick-shaped clinical test tool B adhered to the test tool fixing unit 40. The bent piece portion 50 is formed on the upper side of the inspection tool fixing portion 40, and includes a transparent water-impermeable film 20, an adhesive layer 30, and a release paper 14 that covers the transparent water-impermeable film 20. It is more desirable that the bent piece portion 50 has an area sufficient to completely cover and seal at least the entire stick-shaped clinical test tool B attached to the test tool fixing unit 40 from above.

  Reference numeral 60 denotes a pattern sample of the stick-shaped clinical test tool, which serves as an index for positioning when the stick-shaped clinical test tool B is attached to the test tool fixing portion 40. The pattern sample 60 of the stick-shaped clinical test tool is not necessarily the same as the plane figure of the stick-shaped clinical test tool B to be actually attached, but at least the specimen absorption part 61 and the specimen absorption part 61 are pasted. It is desirable to include a direction arrow display unit 62 and a reaction mark display position display unit 63, and further include a reaction mark meaning display unit 64 and an inspection object display unit 65 as necessary. In addition, the specific display part of the design sample 60 of the stick-shaped clinical test tool is not particularly limited as long as it is parallel to the test tool fixing unit 40, but the mount 10 is related to the display part of the determination reference mark described later. It is desirable to set it as the upper part of the inspection tool fixing part 40 in FIG.

  Reference numeral 70 denotes a determination reference mark, which serves as an evaluation determination reference for the reaction mark appearing in the determination window 101 of the stick-shaped clinical test tool B. For example, in the case of a holding sheet body for a stick-shaped clinical test tool for testing influenza virus as in the example of FIG. 1, the determination reference mark 70 is a type A positive, a type B positive, and a negative character, respectively. It is displayed by the display line. The specific display part of the determination reference mark 70 is desirably the lower part of the test tool fixing part 40 in the mount 10. Thereby, when there is a possibility that a plurality of reaction marks appear, determination of the inspection result becomes easy and misidentification can be prevented.

  Reference numeral 80 denotes a date and name entry column for entering an examination date and a patient's name. The specific display part of the date and name entry field 80 is not particularly limited as long as it is a blank portion of the mount 10, but it is desirable to make the lower right portion of the mount 10 spatially.

  Next, the usage of the holding sheet body for the stick-shaped clinical examination tool of the present invention according to the above embodiment will be described.

  First, as shown in FIG. 2, the release paper 12 is peeled from the mount 10 to expose the pressure-sensitive adhesive layer 30 on the transparent water-impermeable film 20. Next, as shown in FIG. 4, the stick-shaped clinical test tool B is adhered and fixed to the exposed adhesive layer 30 along the design sample 60. Note that the specimen may be absorbed in advance in the specimen absorbing section 100 of the stick-shaped clinical test tool B before sticking and fixing, or may be absorbed in the specimen absorbing section 100 of the stick-shaped clinical testing tool B after sticking and fixing. good.

  Next, as shown in FIG. 2, the release paper 14 of the bent piece 50 is peeled off to expose the transparent water-impermeable film 20 and the pressure-sensitive adhesive layer 30. Next, as shown in FIG. 4, the transparent water impermeable film 20 is bent and the entire stick-shaped clinical examination tool B is covered and sealed from above. Incidentally, the cross-sectional form of the holding sheet body A of the present invention after the release paper 12 and the release paper 14 are peeled is as shown in FIG.

  Next, after standing for a predetermined time, the result is determined by comparing the position of the reaction mark appearing in the determination window portion 101 of the stick-shaped clinical test tool B with the determination reference mark 70. Incidentally, the example shown in FIG. 4 shows negative.

FIGS. 5 to 15 show the design of the stick-shaped clinical examination tool of the present invention, particularly a form of a partial design. FIG. 5 is a front view, FIG. 6 is a rear view, FIG. 7 is a plan view, and FIG. Is a bottom view, FIG. 9 is a right side view, FIG. 10 is a perspective view, FIG. 11 is a reference front view with the release paper partially peeled off, FIG. 12 is a cross-sectional view taken along line AA, and FIG. FIG. 14 is a rear view showing the transparent portion (the hatched portion is the transparent portion), and FIG. 15 is a state in which the stick-shaped clinical examination instrument is set. FIG.
In addition, in FIGS. 5 to 14, the part represented by a solid line is a part that is about to undergo design registration as a partial design, and the alternate long and short dash line is a part that is intended to receive design registration as a partial design and other parts. It is a line indicating only the boundary. The left side view is omitted because it appears symmetrically with the right side view.

Front explanatory drawing of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. Front explanatory drawing of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool which shows the state which peeled the release paper to the middle. II line expanded sectional explanatory drawing. Front explanatory drawing of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tools which shows the state which set the stick-shaped clinical test tool. The front view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. The rear view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. The top view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tools. The bottom view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. The right view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. The perspective view which shows the partial design of the holding | maintenance sheet | seat body for this invention stick-shaped clinical test tool. The reference front view of the state which peeled the release paper in FIG. 5 halfway. AA sectional view taken on the line. The expanded sectional view on the AA line which shows the transparent part of the partial design of the holding | maintenance sheet | seat body for stick-shaped clinical examination tools of this invention. The rear view which shows the transparent part of the partial design of the holding | maintenance sheet | seat body for stick-shaped clinical examination tools of this invention. The reference front view which shows the design of the state which set the stick-shaped clinical test tool to the holding sheet body for this invention stick-shaped clinical test tool.

Explanation of symbols

A: Holding sheet body for stick-shaped clinical test tool B: Stick-shaped clinical test tool 10: Mount 11: Window hole portion 12: Release paper 13: Cutting portion 14: Release paper 20: Transparent water-impermeable film 30: Adhesive layer 40: Inspection tool fixing part 50: Bending piece part 60: Pattern sample 61: Sample absorption part 62: Arrow display part 63: Reaction mark expression position display part 64: Reaction mark meaning display part 65: Inspection object display part 70: Judgment mark 80: Date and name entry column 100: Sample absorption part 101: Judgment window part

Claims (8)

  A holding sheet body for a stick-shaped clinical test tool, characterized in that it comprises a test tool fixing part whose adhesive layer is covered with a release paper.   2. The holding sheet body for a stick-shaped clinical examination tool according to claim 1, wherein the holding sheet body is made of a laminate of a mount, an adhesive layer, and a transparent water-impermeable film.   3. The inspection tool fixing portion is composed of a window hole portion formed in the mount and a release paper that covers the adhesive layer on the transparent water-impermeable film exposed from the window hole portion. The holding sheet body for a stick-shaped clinical examination tool as described.   The stick according to any one of claims 1 to 3, wherein the holding sheet body is provided with a bent piece portion that covers and seals at least the stick-shaped clinical examination tool adhered to the examination instrument fixing portion. A holding sheet for a clinical laboratory test instrument.   The holding for a stick-shaped clinical examination tool according to claim 4, wherein the bent piece portion has an adhesive layer on a transparent water-impermeable film, and the adhesive layer is covered with a release paper. Sheet body.   The stick-shaped sample according to any one of claims 1 to 5, wherein a pattern sample of a stick-shaped clinical test tool is displayed in parallel with the test tool fixing part on the mount surface or the transparent water-impermeable film surface. A holding sheet for clinical testing instruments.   The sticking clinical test instrument holding sheet body according to any one of claims 1 to 6, wherein a judgment reference mark is displayed on the mount surface or the transparent water-impermeable film surface.   8. The holding sheet body for a stick-shaped clinical test tool according to any one of claims 1 to 7, wherein a date and name entry column are provided on the mount surface or the transparent water-impermeable film surface.

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