JP2011095156A - Saliva inspecting tool - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a saliva inspecting tool continuously performing operation from sampling to inspection and preventing the inner wall of the oral cavity from easily abutting on a test drug, or the like. <P>SOLUTION: The saliva inspecting tool 100 includes: an absorber structure 30 including a front-stage absorber 31 for absorbing saliva and an absorber 32 for inspection connected to the front-stage absorber 31 and including a reagent for inspecting saliva; and a vessel 10 for housing the absorber structure 30. The vessel 10 includes a through hole 14 at a part opposing the front-stage absorber 31. <P>COPYRIGHT: (C)2011,JPO&amp;INPIT

Description

  The present invention relates to a saliva test device.

  Conventionally, it is known that the resistance to caries can be known by examining the amount of caries bacteria contained in saliva (for example, see Patent Document 1).

  Various saliva collection devices are known for such examinations (see, for example, Patent Documents 1 to 4).

JP 2007-271469 A U.S. Pat. No. 4,418,702 International Publication WO02 / 08653 Pamphlet International Publication WO2004 / 046693 Pamphlet

  However, the conventional saliva collection device is not simple because it requires operations such as transporting the collection device to an inspection apparatus after collection. When collecting saliva, a saliva collecting device is usually placed in the mouth to collect saliva, but it is not preferable that the inner wall of the mouth (such as the tongue) is in contact with a test drug or the like.

  The present invention has been made in view of the above problems, and an object of the present invention is to provide a saliva testing instrument that can be continuously performed from collection to testing and that the oral cavity wall is less likely to come into contact with a test drug or the like. .

  The saliva test device according to the present invention includes an absorbent body having a pre-stage absorber that absorbs saliva, a test absorbent that is connected to the pre-stage absorber and includes a reagent for saliva test, and the absorbent structure. And a container for housing the container. And the said container has a through-hole in the part facing the said front | former stage absorber.

  According to the present invention, when saliva is absorbed by the pre-stage absorber through the through hole, the saliva reaches the test absorber connected to the pre-stage absorber, and the saliva is inspected by the test absorber. Can do. Thereby, from the collection of saliva to a test can be easily performed with this saliva test device alone without transferring the collected saliva to an inspection device or the like. In addition, since the through-hole is provided on the surface facing the front absorbent body, it is possible to prevent the inner wall of the oral cavity (such as the tongue) from directly touching the absorbent body for examination when the subject's saliva is collected. There is little possibility of accidental ingestion of test drugs contained in the absorber. In addition, this pre-stage absorber can be used as a filter for removing impurities in saliva.

  Here, it is preferable that the through hole has a diameter of the narrowest portion of 0.5 to 5.0 mm, and a plurality of through holes are provided.

  According to this, when collecting saliva, the inner wall of the oral cavity (such as the tongue) is less likely to touch the pre-absorber, and sufficient saliva can be collected.

  Moreover, it is preferable that an internal diameter becomes small so that a through-hole goes to a front | former stage absorber.

  Thereby, contact with a tongue and a front stage absorber can be controlled, maintaining inhalation of saliva.

  Moreover, it is preferable that the back surface of the edge part which forms the through-hole in a container is contacting the front | former stage absorber.

  Thereby, the absorption of the saliva by the front | former stage absorber is attained rapidly.

  Further, it is preferable that a protrusion is provided on the back surface of the edge portion forming the through hole in the container, and the protrusion penetrates the front absorbent body and contacts the bottom of the container.

  Thereby, the height of the former absorbent body is maintained, and it is easy to maintain the ease of saliva absorption and flow even when the container is held with teeth.

  Moreover, it is preferable that an absorber structure further has a back | latter stage absorber connected to the back | latter stage of the absorber for a test | inspection.

  Thereby, a large amount of saliva can be supplied to the test absorber, and the detection sensitivity is improved. Moreover, even when saliva is supplied in large quantities, the backflow of saliva can be suppressed.

  In addition, the test absorber is connected to the first test absorber that specifically binds to the analyte and elutes the labeled labeled molecule recognition element, and the subsequent stage of the first test absorber. The saliva test device according to any one of claims 1 to 6, further comprising a second test absorber on which a molecular recognition element that specifically binds to the analyte and / or the labeled molecule recognition element is fixed.

  According to this, a specific bacterium in the supplied saliva binds to the labeled molecule recognition element in the first to form a complex, and this complex is fixed by the molecule recognition element in the second test absorbent. And concentrated. Therefore, it is possible to easily determine the presence / absence and concentration of a specific bacterium according to the concentration state (for example, color) of the label in the second inspection absorber.

  Moreover, it is preferable that a test | inspection absorber has a 3rd test | inspection absorber which is impregnated with the pH indicator connected to the front | former stage absorber.

  Thereby, measurement of pH is attained.

  According to the present invention, it is possible to provide a saliva testing device that can be continuously performed from collection to testing and that the oral cavity wall is less likely to come into contact with a test drug or the like.

It is a perspective view of the saliva test device concerning this embodiment. FIG. 2 is a partially broken and exploded perspective view of FIG. 1. It is sectional drawing of the III-III line of FIG.

  DESCRIPTION OF EMBODIMENTS Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. In the description of the drawings, the same or equivalent elements will be denoted by the same reference numerals, and redundant description will be omitted.

(Saliva testing instrument)
As shown in FIG.1 and FIG.2, the saliva test | inspection instrument 100 which concerns on this embodiment mainly is provided with the container 10 which mainly accommodates the absorber structure 30 and the absorber structure 30. As shown in FIG.

(Absorber structure)
As shown in FIG. 2, the absorber structure 30 includes, in order, from a first side in the longitudinal direction of the container 10 toward the other end side (toward the Y direction), a front-stage absorber 31, an inspection absorber 32, A post-stage absorber 36 and a water detection member 37 are provided.

  The material of the upstream absorber 31 is not particularly limited as long as it can absorb saliva. As the pre-stage absorber 31, it is preferable to use a porous material that does not contain a protein component, and in particular, a sheet-like material is preferable. Examples of the porous form include aggregates of fibers, foams, gels, and the like. Specific examples include paper such as filter paper, rubber or resin foam (sponge), woven fabric, non-woven fabric, knitted fabric, water-absorbing polymer, and the like.

  The material for forming such an absorber is not particularly limited, but for example, cotton, hemp, cellulose, nitrocellulose, cellulose acetate, rock wool, glass fiber, silica fiber, carbon fiber, boron fiber, polyamide, aramid , Regenerated cellulose such as polyvinyl alcohol, polyvinyl acetate, rayon, polyester, polyurethane, nylon, polyacrylic acid, polyacrylic ester, polyethersulfone, polysulfone, polytetrafluoroethylene, polyvinylidene difluoride, and polyolefin, water absorption Examples thereof include polymers.

  The thickness of the former absorbent body is not particularly limited, but is preferably 0.05 to 5.0 mm. The pore size of the former absorbent body is not particularly limited, but is preferably 10 to 200 μm in order to remove impurities contained in saliva such as viscous substances, mucosal cells, and proteins.

  Although only one type of absorber can be used, several types can be used in combination, and the embodiment is not particularly limited. The absorber can be used as it is, but it can also be used by adhering to a non-absorber as a substrate. As the non-absorber, for example, a sheet-like material can be used. Examples of the material for forming the non-absorbent include polymers such as polyethylene terephthalate, polyester, polypropylene, polyethylene, polyvinyl chloride, polyvinylidene chloride, and polystyrene, glass, and various metals.

(Absorber for inspection)
The inspection absorber 32 includes a first inspection absorber 33, a second inspection absorber 34, and a third inspection absorber 35, and includes a reagent for inspecting an analysis object in saliva.

  Analytes in saliva are not particularly limited, but any protein, glycoprotein, saccharide, vitamin, dye, fluorescent molecule, peptide, nucleic acid, antibody, antigen, hormone, metal, metal ion, cell, cell tissue, bacteria or Examples thereof include microorganisms such as viruses, other natural compounds, and synthetic compounds.

(Absorber for first inspection)
In the first inspection absorber 33, the end portion in the −Y direction is overlapped with the end portion of the pre-stage absorber 31. The first inspection absorber 33 is a member in which an absorber is impregnated with a labeled molecule recognition element (reagent), and the impregnated labeled molecule recognition element can be eluted from saliva.

  A labeled molecule recognition element is a molecule recognition element that specifically binds to an analyte to form a complex and is labeled. As the absorber of the first inspection absorber 33, the same absorber as the former-stage absorber 31 can be used.

  The molecular recognition element is not particularly limited as long as it specifically binds to the analyte and forms a complex. Antigen, antibody (monoclonal antibody, polyclonal antibody, etc.), nucleic acid sequence fragment, effector molecule, receptor Examples include molecules, enzymes and their inhibitors, coenzymes, avidin, biotin, sugar chain compounds, lectins, aptamers (DNA aptamers, RNA aptamers, peptide aptamers, etc.), molecular templates, and the like.

  Labels include colloidal gold, silver colloidal particles, platinum colloidal and other metal colloids, colored lipid vesicles (ribosomes) and vesicles, latex particles that may be colored, various fine particles such as magnetic fine particles, fluorescent substances, and coloring. Substances, luminescent substances, enzymes, biotin, radioisotopes, redox substances and the like can be mentioned.

(Absorber for second inspection)
In the second inspection absorber 34, the end portion in the −Y direction is overlapped with the end portion of the first inspection absorber 33. The second inspection absorber 34 has a function of trapping a complex in which the labeled molecule recognition element and the analyte are bound in the first inspection absorber 33 and allowing the unbound labeled molecule recognition element to pass through. Absorber. As a method of exerting this function, it is conceivable to adjust the pore diameter of the absorber. For example, in order to trap caries-causing bacteria (Streptococcus mutans, Streptococcus sobrinus, Lactobacillus acidophilus, etc.), the pore size of the absorber is preferably 0.2 to 10 μm. Thereby, the composite_body | complex which microbe and the labeled molecule | numerator recognition element couple | bonded can be trapped.

  Moreover, as a method for expressing the above function, it is also preferable to fix a molecular recognition element (reagent) that specifically binds to the complex analyte and / or the labeled molecule recognition element to the absorber. The molecular recognition element may be the same as or different from the first inspection absorber 33.

  As the material of the absorbent body of the second inspection absorbent body 34, the same material as that of the upstream absorbent body 31 can be used.

(Absorber for third inspection)
The third inspection absorber 35 has an end in the −Y direction overlapped with an end of the pre-stage absorber 31. The third test absorber 35 is an absorber impregnated with a pH indicator (reagent).

The pH indicator is not particularly limited as long as it shows a color change in the saliva pH range (about 4 to 8). For example, phthalein, sulfophthalein, azo, triphenylmethane, benzein, nitro These can be used alone or in combination. For example, the following can be mentioned.
Methyl yellow Red 2.9-4.0 Yellow
Bromophenol blue Yellow 3.0-4.6 Purple
Congo red Blue purple 3.0-5.0 Red
Methyl orange Red 3.1-4.4 Orange
Bromocresol green yellow 3.8-5.4 blue green
Methyl red Red 4.4-6.2 Yellow
Methyl Red / Bromocresol Green Red 4.5-5.2 Green
Litmus Red 4.5-8.3 Blue
Bromocresol purple yellow 5.2-6.8 purple
Bromothymol blue Yellow 6.0-7.6 Blue
Phenol red Yellow 6.8 to 8.4 Red
Neutral red Red 6.8-8.0 Yellow
Naphthanolphthalein Slightly red 7.3-8.7 Blue green
Cresol red Yellow 7.2-8.8 Magenta
The width in the X direction of the first and second inspection absorbers 33 and 34 is preferably wider than the width of the third inspection absorber 35.

(Second-stage absorber)
The post-stage absorber 36 has an end portion in the −Y direction overlapped with an end portion of the second inspection absorber 34. The post-stage absorber 36 is for absorbing the saliva that has passed through the second inspection absorber 34, further promoting the movement of the saliva, and further improving the sensitivity.

  As the rear-stage absorber 36, the same one as the front-stage absorber 31 can be used.

(Water detection member)
The water detection member 37 is provided so as to overlap the end portion on the + Y direction side of the rear-stage absorber 36. The water detection member detects that liquid water has arrived and displays the end of the inspection.

  The water detection member 37 is not particularly limited as long as it notifies contact with liquid water. For example, by selectively impregnating the lower layer of the absorber similar to the former absorber 31 with the dye, the dye applied to the lower layer of the absorption pad oozes out and becomes visible when wet with water. Mechanism, a completion mark is printed on the lower layer, an opaque layer (for example, hydrophilic polytetrafluoroethylene) that becomes transparent when wet with water is placed on the upper layer, and a completion mark printed on the lower layer of the absorbent carrier when wet Examples include a mechanism of lifting, a mechanism of viewing the discoloration of filter paper impregnated with a pH indicator (such as litmus, phenol red, neutral red, phenolphthalein, naphthalanolphthalein, and cresol red) that changes color from neutral to acidic.

(container)
The container 10 has a long and thin rectangular parallelepiped shape. The material of the container is not particularly limited, and examples thereof include resins such as polypropylene, polystyrene, silicone, polyethylene, polymethyl methacrylate, and acrylic.

  The container 10 has a main body portion 12 and a lid portion 11. The main body 12 has a box shape with a bottom and an open top. In the main body 12, the above-described absorber structure 30 is accommodated in the Y direction.

  As shown in FIG. 2, the third inspection absorber 35, the first inspection absorber 33, the second inspection absorber 34, and the rear-stage absorber 36 are separated from each other. 13 is provided. Thereby, mixing with a pH indicator and the reagent of the absorber for a test | inspection etc. is suppressed.

  The lid portion 11 is fixed to the edge of the main body portion 12 with an adhesive, screws, caulking, or the like.

  A plurality of through holes 14 are formed in a portion of the lid portion 11 that faces the upstream absorber 31. The size of the diameter of the through hole 14 is not particularly limited, but the diameter of the narrowest part is 0.5 to 5.0 mm in order to suppress contact between the oral cavity inner wall (tongue or the like) and the pre-stage absorber 31. Is preferable, and it is more preferable that it is 1.0-5.0 mm.

  Moreover, as shown in FIG. 3, it is preferable that the through-hole 14 exhibits a taper shape whose diameter becomes narrower from the outside toward the inside so as to suppress contact between the tongue of the subject and the front absorbent body 31. In addition, even if it is a through-hole with a fixed diameter, it can be implemented with a reverse-taper through-hole.

  Further, a needle 15 that penetrates the front absorbent body 31 and contacts the bottom surface 12 a of the main body 12 is formed on the back surface 11 a of the edge portion (portion around the through hole) that forms the through hole 14 in the lid portion 11. ing. Thereby, even when the subject bites the container, the thickness of the front absorbent body 31 is maintained.

  Further, as shown in FIG. 1, the lid 11 has an opening 16 for exposing the third inspection absorber 35, an opening 17 for exposing the second inspection absorber 34, and an opening 18 for exposing the water detection member 37. Is formed.

  As shown in FIG. 2, the thickness of the container 10 is such that the portion of the front absorbent body 31 is thinner than the other portions, and as shown in FIG. 3, the edge forming the through hole 14 in the lid portion 11. The back surface 11 a of the part is in contact with the upstream absorber 31.

  Then, the usage method of such a saliva test | inspection instrument 100 is demonstrated.

  First, test subjects chew gum for about 1 minute to encourage saliva secretion. At this time, after waking up, it is preferable to do before brushing teeth, wrinkles, eating and drinking.

  Subsequently, the subject is allowed to store saliva in the oral cavity, and in that state, the portion where the through-hole 14 of the saliva test instrument 100 is formed is added to the oral cavity, and the saliva is sufficiently absorbed through the through-hole 14. 31.

  The saliva absorbed in the upstream absorber 31 flows through the upstream absorber 31, a part of which reaches the third inspection absorber 35, and the color of the third inspection absorber 35 depends on the pH of the saliva. Color.

  The saliva and other parts absorbed by the pre-stage absorber 31 reach the first test absorber 33, and the labeled molecule recognition element specifically binds to a specific analyte in the saliva. For example, aptamers labeled with colloidal gold specifically bind to caries-causing bacteria such as Streptococcus mutans, Streptococcus sobrinus, Lactobacillus acidophilus, and the like.

  Further, the saliva reaches the second inspection absorber 34 from the first inspection absorber 33, and the complex of the labeled molecule recognition element and the analysis target in the first inspection absorber 33 is used for the second inspection. It is trapped in the absorber 34 and the label is concentrated. For example, a complex is trapped by a molecular recognition element that specifically binds to a caries-causing bacteria or a labeled molecule recognition element, the gold colloid is concentrated, and a red color is formed. At this time, the concentration depends on the amount of the complex. It will be different.

  At this time, the unbound labeled molecule recognition element is not trapped in the second inspection absorber 34 but passes downstream. Further, the saliva passes through the rear-stage absorber 36 and reaches the water detection member 37. When the water detection member 37 comes into contact with saliva, a water detection sign appears and the inspection is completed.

  According to the present embodiment, saliva is absorbed by the pre-stage absorber 31 through the through-hole 14, so that the saliva reaches the test absorber 32 connected to the pre-stage absorber 31, and the test absorber 32. The saliva test, for example, pH test, determination of the concentration of caries-causing bacteria, and the like can be performed. Thereby, from the collection of saliva to the inspection can be easily performed with the saliva inspection instrument 100 alone without transferring the collected saliva to an inspection apparatus or the like. Moreover, since the through-hole 14 is provided in the surface facing the front | former stage absorber 31, it can suppress that an oral cavity inner wall (tongue etc.) touches the test | inspection absorber 32 directly when extract | collecting a test subject's saliva. However, there is little possibility of accidentally ingesting various reagents contained in the test absorber 32. In addition, the pre-stage absorber 31 can also function as a filter that removes impurities in the saliva.

For example, the threshold mutans concentration of 10 ⁶ cells / mL in saliva, by so changing the coloration degree of second detection absorber 34, it is possible to evaluate the risk of dental caries.

  The present invention is not limited to the above embodiment, and various modifications can be made. For example, the absorber structure may be integrally formed instead of the overlapping structure of the absorbers.

  Moreover, when the cover part 11 is transparent, the openings 16, 17, and 18 may not be provided.

  A single through hole 14 can be implemented. In this case, if the diameter of the through-hole 14 is increased, the tongue or the like touches the front-stage absorber 31, but if the inspection absorber 32 is not touched, the possibility of accidentally ingesting the reagent is still low.

  You may interpose another absorber between each absorber. The inspection absorber 32 includes a first inspection absorber 33, a second inspection absorber 34, and a third inspection absorber 35, but the first inspection absorber 33 and the second inspection absorber. 34 may be sufficient and the absorber 35 for a 3rd test | inspection only may be sufficient. Moreover, it cannot be overemphasized that the absorber for a test | inspection which has the reagent for a saliva test | inspection other than these individually or in combination may be sufficient.

  Further, the present invention can be implemented without the rear-stage absorber 36 and the water detection member 37.

Example 1
A saliva test instrument as shown in FIGS. The saliva testing device 100 is provided with a plurality of through holes 14 having a diameter of the narrowest portion of 2.5 mm. Non-woven glass fiber (pore diameter 10 μm) was used for the former absorbent body 31. As the first test absorbent 33, non-woven glass fiber impregnated with an aptamer labeled with colloidal gold and capable of specifically binding to Streptococcus mutans (Sm) bacteria was used. For the second test absorber 34, FUSION5 manufactured by Whatman Co., Ltd., to which a molecular recognition element capable of aggregating colloidal gold and coloring it in a strip shape by trapping a complex in which Sm bacteria and aptamer are bound, is fixed. Using. As the post-stage absorbent body 36, an absorbent pad made of cotton linter was used in which a sign indicating the completion of the reaction when moisture reaches it appeared.
When the subject put it in his mouth, the test could be done without accidentally swallowing the reagent.

(Example 2)
The following table shows the results of comparing the performance of the narrowest portion of the through-hole of the saliva testing instrument 100 and comparing the performance. In this example, the pre-absorber is pre-impregnated with a safe red food even if it enters the subject's mouth, and it is confirmed whether the pre-absorber and the tongue come into contact with each other through the through hole depending on whether or not the tongue is colored. did. The detection time is the time from when the subject puts the instrument in his mouth until moisture reaches the latter-stage absorber and a label indicating the completion of the reaction appears.
Table 1 shows the evaluation of Examples 1 and 2.

  When the diameter of the narrowest part of the through-hole was 0.1 mm, the tongue and the pre-absorbent body 31 were not in contact at all. However, in the case of saliva with high viscosity, it took time to detect. On the other hand, in the case of 6.0 mm, although saliva is rapidly absorbed, the contact between the tongue and the pre-absorber 31 also easily occurs, and coloring of the tongue due to food red was detected. However, even in this case, the safety is high because the contact is made with the saliva remaining in the upstream absorber 31 instead of the test absorber 32 impregnated with the detection reagent. In the performance column, ◎ indicates that the performance is remarkably excellent, ○ indicates that the performance is quite excellent, and Δ indicates that the performance is excellent.

  DESCRIPTION OF SYMBOLS 10 ... Container, 14 ... Through-hole, 15 ... Protrusion, 30 ... Absorber structure, 31 ... Pre-stage absorber, 32 ... Inspection absorber, 33 ... First inspection absorber, 34 ... Second inspection absorber 35 ... Absorber for third inspection, 36 ... Absorber for rear stage, 37 ... Water detection member, 100 ... Instrument for saliva test.

Claims (8)

An absorbent body structure having a pre-absorber that absorbs saliva, and a test absorbent that is connected to the pre-stage absorber and contains a reagent for saliva testing;
A container for containing the absorbent structure,
The said container is a saliva test | inspection instrument which has a through-hole in the part facing the said front | former stage absorber.   The saliva test device according to claim 1, wherein a plurality of the through holes have a diameter of a narrowest portion of 0.5 to 5.0 mm, and a plurality of the through holes are provided.   The saliva testing instrument according to claim 1 or 2, wherein the through hole has an inner diameter that decreases toward the front absorbent body.   The saliva test device according to any one of claims 1 to 3, wherein a back surface of an edge portion forming the through hole in the container is in contact with the front-stage absorber.   The saliva according to any one of claims 1 to 4, wherein a protrusion is provided on a back surface of an edge portion forming the through-hole in the container, and the protrusion penetrates the front absorbent body and contacts the bottom of the container. Inspection instrument.   The saliva test device according to any one of claims 1 to 5, wherein the absorbent structure further includes a rear-stage absorber connected to a rear stage of the test absorber.   The test absorber is connected to the first test absorber that specifically binds to the analyte and elutes the labeled labeled molecule recognition element, and is connected to the subsequent stage of the first test absorber. The saliva test device according to any one of claims 1 to 6, further comprising a second test absorber on which a molecular recognition element that specifically binds to the analyte and / or the labeled molecule recognition element is fixed.   The saliva test device according to any one of claims 1 to 7, wherein the test absorber includes a third test absorber that is impregnated with a pH indicator and is connected to the upstream absorber.

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