CN203385732U - Test strip for detecting pepsinogen I and reagent card with test strip - Google Patents

Test strip for detecting pepsinogen I and reagent card with test strip Download PDF

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Publication number
CN203385732U
CN203385732U CN201320495844.9U CN201320495844U CN203385732U CN 203385732 U CN203385732 U CN 203385732U CN 201320495844 U CN201320495844 U CN 201320495844U CN 203385732 U CN203385732 U CN 203385732U
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China
Prior art keywords
propepsin
monoclonal antibody
test strips
cellulose nitrate
pad
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Expired - Lifetime
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CN201320495844.9U
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Chinese (zh)
Inventor
黄飚
周衍
邹霈
蒋叶华
王翌
张珏
张艺
周彬
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Jiangsu Institute of Nuclear Medicine
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Jiangsu Institute of Nuclear Medicine
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Abstract

The utility model provides a test strip for detecting pepsinogen I and a reagent card with the test strip. The test strip comprises a bottom board as well as water absorbing paper, a cellulose nitrate envelope membrane, a monoclonal antibody combination pad and a sample pad which are adhered to the bottom board in sequence along the length direction of the test strip, wherein the cellulose nitrate envelope membrane is adhered to the middle part of the bottom board; a detection band and a quality control band are arranged on the cellulose nitrate envelope membrane at an interval; the detection band is close to the monoclonal antibody combination pad; the quality control band is close to the water absorbing paper; the monoclonal antibody combination pad is a polyester membrane, on which fluorescent microspheres with the surfaces modified by pepsinogen I monoclonal antibodies I are sprayed. According to the test strip for detecting pepsinogen I and the reagent card with the test strip disclosed by the utility model, quick and individual quantitative detection can be quickly realized, the sensitivity is high, between-lot and between-run errors are small, and great convenience is provided for clinical use.

Description

A kind of reagent card that detects the test strips of propepsin I and apply it
Technical field
The utility model relates to the clinical immunology detection field, is specifically related to a kind of reagent card that fast, quantitatively detects the fluorescence immune chromatography test paper bar of propepsin I and apply it.
Background technology
Propepsin (English full name is Pesinogen, is called for short PG) is pepsic inactive precursor in gastric juice, is divided into pepsinogen I (being called for short PGI) and pepsinogen I I(and is called for short PGII).PGI is mainly by chief cell and the mucous neck cell secretion of fundus gland, and the disease of upper digestive tract such as serum PG I content and gastric ulcer, duodenal ulcer, atrophic gastritis, cancer of the stomach have substantial connection.Disease of digestive tract be can detect by measuring PGI content, clinical detection and health check-up examination have been widely used in.
Detection for pepsinogen I, clinical method commonly used comprises at present: Immunoturbidimetry, euzymelinked immunosorbent assay (ELISA) (ELISA), time resolved fluoro-immunoassay method (TRFIA) and radio immunoassay (RIA), but these methods have characteristics and deficiency separately.Radio immunoassay (RIA) reagent used has radioactivity and the term of validity is short, generally recommendation not; Immunoturbidimetry, simple to operate, can be full-automatic, still, its sensitivity is not high, can't realize accurate quantification; Although ELISA method and time resolution immunization can be quantitatively accurate, the operating process complexity, and be not suitable for single part and detect and use than short run.
The utility model content
For this reason, to be solved in the utility model is the technical matters that the detection method of pepsinogen I in prior art can not be taken into account high sensitivity and simple operations, provide a kind of simple to operate, highly sensitive, can fast, quantitatively detect the fluorescence immune chromatography test paper bar of pepsinogen I and apply its reagent card.
For solving the problems of the technologies described above, the technical solution adopted in the utility model is as follows:
A kind of test strips that detects the propepsin I described in the utility model comprises:
Base plate, and cover in turn thieving paper, cellulose nitrate coated film, monoclonal antibody pad and the sample pad on described base plate along described floor length direction; Wherein,
Described cellulose nitrate coated film covers the middle part in described base plate, and be provided with the detection band that is coated with propepsin I monoclonal antibody II separately on it and be coated with the quality control band of the anti-mouse lgG of rabbit antibody, described detection band is near described monoclonal antibody pad, and described quality control band is near described thieving paper;
Described monoclonal antibody pad is the polyester film of fluorescent microsphere of propepsin I monoclonal antibody I that has been coated with finishing;
Between described thieving paper, described cellulose nitrate coated film, described monoclonal antibody pad and described sample pad, successively with and only with adjacent regions, contact and partly overlap.
The particle diameter of described fluorescent microsphere is 10~1000nm.
The width of described test strips is 0.3~2cm.
Between described thieving paper, described cellulose nitrate coated film, described monoclonal antibody pad and described sample pad, successively with and only with the adjacent regions regional overlap length 1~5mm of being independent of each other that partly overlaps.
The described upside of zone at described cellulose nitrate coated film that partly overlap of described thieving paper and described cellulose nitrate coated film.
Described base plate is plastic bottom board.
A kind of reagent card that detects the propepsin I described in the utility model, comprise described test strips and the shell that coats described test strips; Described shell further comprises base and Ka Gai, and described card covers and is provided with observation panel and adding mouth, to expose the regional area of test strips; Described adding mouth is opened on described sample pad top, with exposed portions serve or whole described sample pad zone; Described observation panel is opened on described coated film upside, to expose whole described detection bands and described quality control band.
Described base is plastic feet.
Described Ka Gai is the plastic clip lid.
Technique scheme of the present utility model has the following advantages compared to existing technology:
1, the fluorescence immune chromatography reagent strip of detection propepsin I provided by the utility model be take fluorescent microsphere as signal source, the volume of fluorescent microsphere is much larger than the volume of luminescent dye molecule, not only can a large amount of luminescent dye molecule of load, and be convenient to luminescent dye molecule in the gathering that detects band and quality control band place, play the effect that signal amplifies, can realize quick, single part quantitatively detecting, and highly sensitive, error is little, for clinical use provides a great convenience.
2, the fluorescence immune chromatography reagent card of detection propepsin I provided by the utility model, volume is little, be easy to carry, and is easy to preserve, and is conducive to application and the popularization of basic hospital.
3, the fluorescence immune chromatography reagent card of detection propepsin I provided by the utility model, the preparation method is simple, can realize batch production.
The accompanying drawing explanation
For content of the present utility model is more likely to be clearly understood, below according to specific embodiment of the utility model also by reference to the accompanying drawings, the utility model is described in further detail, wherein
Fig. 1 is a kind of structural representation that detects the reagent card of propepsin I described in the utility model;
Fig. 2 is that a kind of test strips that detects the propepsin I described in the utility model is arranged on the front view on base;
Fig. 3 is the side view of test strips described in the utility model.
In figure, Reference numeral is expressed as: 1-base, 2-Ka Gai, 3-test strips, 4-base plate, 5-sample pad, 6-monoclonal antibody pad, 7-cellulose nitrate coated film, 8-thieving paper, 9-detect band, 10-observation panel, 11-quality control band, 12-adding mouth.
Embodiment
In order to make the purpose of this utility model, technical scheme and advantage clearer, below in conjunction with accompanying drawing, embodiment of the present utility model is described in further detail.
The utility model can be implemented in many different forms, and should not be understood to be limited to embodiment set forth herein.On the contrary, provide these embodiment, it will be openly thorough and complete making the utility model, and will fully convey to those skilled in the art to design of the present utility model, and the utility model will only be limited by claim.In the accompanying drawings, for clarity, can exaggerate the layer and regional size and relative size.
In following embodiment, described propepsin I monoclonal antibody I, propepsin I monoclonal antibody II, the anti-mouse lgG of rabbit antibody, phosphate buffer solution, bovine serum albumin(BSA) (BSA), Triton X-100 (TritonX-100), 2-(N-morpholine) ethyl sulfonic acid (MES) buffer solution, be enclosed with fluorescent dye and finishing and have the polystyrene spheres of amino or carboxyl, carbodiimide (EDC), the inferior acid amides (NHS) of N-hydroxyl amber, sucrose, polyester film, nitrocellulose filter, glass fibre element film, high-intensity water absorbent paper to be commercially available.
As Figure 1-3, the utility model provides a kind of fluorescence immune chromatography test paper bar 3 that detects the propepsin I, described test strips 3 comprises base plate 4, and covers in turn thieving paper 8, cellulose nitrate cellulose nitrate coated film 7, monoclonal antibody pad 6 and the sample pad 5 on described base plate 4 along described test strips 3 length directions.
Described cellulose nitrate cellulose nitrate coated film 7 covers in the middle part of described base plate 4, and be provided with detection separately on it and be with 9 and quality control band 11, described detection is with 9 near described monoclonal antibody pad 6, and described quality control band 11 is near described thieving paper 8.
Described monoclonal antibody pad 6 is the polyester films of fluorescent microsphere of propepsin I monoclonal antibody I that have been coated with finishing.
Described sample pad 5 is glass fibre element films.Described detection is the propepsin I monoclonal antibody II bands that are coated on described cellulose nitrate with 9, and quality control band 11 is the anti-mouse lgG of the rabbit antibody bands that are coated on described cellulose nitrate coated film 7.
Between described thieving paper 8, described cellulose nitrate cellulose nitrate coated film 7, described monoclonal antibody pad 6 and described sample pad 5, successively with and only with adjacent regions, contact and partly overlap.
The present embodiment also provides a kind of reagent card that detects the propepsin I, comprises described test strips 3 and the shell that coats described test strips 3; Described shell further comprises base 1 and Ka Gai 2, is provided with observation panel 10 and adding mouth 12 on described card lid 2, to expose the regional area of test strips 3; Described adding mouth 12 is opened on described sample pad 5 tops, with exposed portions serve or whole described sample pad 5 zones; Described observation panel 10 is opened on described cellulose nitrate coated film 7 upsides, to expose whole described detections, is with 9 and described quality control band 11.
Described base plate 4 is plastic bottom boards.The particle diameter of described fluorescent microsphere is 10~1000nm, the preferred 200nm of the present embodiment.Described fluorescent microsphere is the polystyrene spheres that is enclosed with fluorescent dye, and is modified with mouse monoclonal antibody; Described thieving paper 8 preferred high strength thieving papers; Described base 4 is plastic feets, preferably Polyvinylchloride (PVC) plate.
The preparation method of the fluorescence immune chromatography reagent card of described detection propepsin I is:
S1, prepare base 1 and have the card lid 2 of observation panel 10, adding mouth 12, described base 1 and the Ka Gai 2 rear formation that is interlocked only has the hollow cavity of observation panel 10,12 two openings of adding mouth, and described base 1 be plastic feet, and described card lid 2 is that plastic clip covers.
S2, purification propepsin I monoclonal antibody I.Selecting commercialization propepsin I monoclonal antibody I, under 4 ℃ of conditions, is 0.05mol/L by concentration, and the pH value is the right commercialization propepsin I monoclonal antibody I of phosphate buffer solution of the 7.2-7.6 purification processes of being dialysed.
S3, preparation monoclonal antibody pad 6.Described fluorescent microsphere selects commercialization to be enclosed with the polystyrene spheres that fluorescent dye and finishing have amino or carboxyl, and particle diameter is 200nm; At first by concentration, be 0.05mol/L, the MES that the pH value is 7.2-7.6 rushes the right fluorescent microsphere of solution and carries out carrying out washing treatment, and mass concentration is adjusted into to 1%, then use the mode of inferior acid amides (NHS) covalent coupling of carbodiimide (EDC) and N-hydroxyl amber to be marked on described fluorescent microsphere processing the propepsin I monoclonal antibody I obtained in step S2; Re-use quantitative spray film instrument and will be marked with propepsin I monoclonal antibody I with the amount of 3~5 μ l/cm and be sprayed on polyester film, dry 1 hour for 35~38 ℃ under the lucifuge condition, make monoclonal antibody pad 6, add drying agent to seal up for safekeeping standby.The volume of fluorescent microsphere is much larger than the volume of luminescent dye molecule, not only can a large amount of luminescent dye molecule of load, and be convenient to luminescent dye molecule in detection with 8 and the gathering at quality control band 11 places, play the effect that signal amplifies.
S4, prepare cellulose nitrate coated film 7.The concentration that use contains 1wt% sucrose is 0.05mol/L, the phosphate buffer solution that the pH value is 7.4 respectively by propepsin I monoclonal antibody II, the anti-mouse lgG of rabbit antibody, be diluted to the concentration of 1mg/ml, re-using quantitative spray film instrument is sprayed on the two interval on nitrocellulose filter with the amount of 1 μ l/cm, dry 1 hour for 35~38 ℃, make and comprise and detecting with 9 and the cellulose nitrate coated film 7 of quality control band 11, add drying agent to seal up for safekeeping standby.
S5, preparation sample pad 5.By the concentration that contains 1wt%BSA, 0.1wt%tritonx-100, be 0.02mol/L, the phosphate buffer solution that the pH value is 7.4 soaks glass fibre element film 0.5~3 hour, dries 3 hours, makes sample pad 5 for 35~38 ℃.
S6, assembling test strips 3.Be less than 35% in humidity, temperature is to carry out the assembling of test strips 3 under 20~25 ℃ of conditions, described base plate 4 is selected Polyvinylchloride (PVC) plate, on the length direction of the same face of described base plate 4, connect in turn and the partly overlapping sample pad 5 of adjacent regions, monoclonal antibody pad 6, cellulose nitrate coated film 7, thieving paper 8, the described regional overlap length that partly overlaps is 1~5mm, the preferred 2mm of the present embodiment; When described cellulose nitrate coated film 7 arranges, be followed successively by detect on the direction away from described sample pad 5 and be with 9 and quality control band 11, described thieving paper 8 is high-intensity water absorbent paper; Cut the test strips 3 that the formation width is 0.3~2cm, the preferred 0.5cm of the present embodiment after assembling.
S7, assembling detect the fluorescence immune chromatography reagent card of propepsin I.The test strips 3 prepared in step S6 is arranged between two parties on described base 1, and described base plate 4 is connected with described base 1, fastens card and covers 2, and described observation panel 10 is over against cellulose nitrate coated film 7, and adding mouth 12 is over against sample pad 5; Add drying agent in the hollow cavity that also can form after described base 1 and Ka Gai 2 are interlocked.
During use, sample liquid is added drop-wise on sample pad 5 by adding mouth 12, under capillary action, sample liquid is moving to thieving paper 8 one breathing arm, while containing the propepsin I in sample liquid, propepsin I monoclonal antibody I on propepsin I and fluorescent microsphere forms antigen-antibody complex, along with the chromatography effect, described antigen-antibody complex continues to thieving paper 8 one breathing arm moving, arrive the propepsin I monoclonal antibody II place of the different epitopes of identification, detect and be with 9 places, form antibody-antigen-antibody complex, form the gathering with the fluorescent microsphere of antibody-antigen-antibody complex in detection with 9 places.And not moving to thieving paper 8 one breathing arm in conjunction with the fluorescent microsphere continuation of monoclonal antibody I, while arriving quality control band 11, the mouse monoclonal antibody of the anti-mouse lgG of rabbit antibody on fluorescent microsphere is combined, the gathering of at quality control band 11 places, producing the line fluorescent microspheres.
After reacting completely, the fluorescence immune chromatography reagent card of above-mentioned detection propepsin I is placed in fluorescence detector, read and detect with 9 and 11 liang of fluorescence signals of locating of quality control band, read value and default standard value are compared and just can be calculated quantitative result.
The fluorescence immune chromatography reagent card of detection propepsin I provided by the utility model can be realized quick, single part quantitatively detecting, and highly sensitive, in batch, batch between error little, for clinical use provides a great convenience; And volume is little, be easy to carry, be easy to preserve, be conducive to application and the popularization of basic hospital; In addition, the preparation method is simple, can realize batch production.
Obviously, above-described embodiment is only for example clearly is described, and is not the restriction to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without also giving all embodiments.And the apparent variation of being extended out thus or change are still among protection domain of the present utility model.

Claims (9)

1. a test strips that detects the propepsin I, is characterized in that, comprising:
Base plate (4), and cover in turn thieving paper (8), cellulose nitrate coated film (7), monoclonal antibody pad (6) and the sample pad (5) on described base plate (4) along described base plate (4) length direction; Wherein,
Described cellulose nitrate coated film (7) covers in the middle part of described base plate (4), and be provided with the detection band (9) that is coated with propepsin I monoclonal antibody II separately on it and be coated with the quality control band (11) of the anti-mouse lgG of rabbit antibody, described detection band (9) is near described monoclonal antibody pad (6), and described quality control band (11) is near described thieving paper (8);
Described monoclonal antibody pad (6) is the polyester film of fluorescent microsphere of propepsin I monoclonal antibody I that has been coated with finishing;
Between described thieving paper (8), described cellulose nitrate coated film (7), described monoclonal antibody pad (6) and described sample pad (5), successively with and only with adjacent regions, contact and partly overlap.
2. a kind of test strips that detects the propepsin I according to claim 1, is characterized in that, the particle diameter of described fluorescent microsphere is 10~1000nm.
3. a kind of test strips that detects the propepsin I according to claim 1 and 2, is characterized in that, the width of described test strips is 0.3~2cm.
4. a kind of test strips that detects the propepsin I according to claim 3, it is characterized in that, between described thieving paper (8), described cellulose nitrate coated film (7), described monoclonal antibody pad (6) and described sample pad (5), successively with and only with the adjacent regions regional overlap length 1~5mm of being independent of each other that partly overlaps.
5. a kind of test strips that detects the propepsin I according to claim 4, is characterized in that, the described upside of zone at described cellulose nitrate coated film (7) that partly overlap of described thieving paper (8) and described cellulose nitrate coated film (7).
6. a kind of test strips that detects the propepsin I according to claim 5, is characterized in that, described base plate (4) is plastic bottom board.
7. a reagent card that detects the propepsin I, is characterized in that, comprises the described test strips of one of claim 1-6 and the shell that coats described test strips; Described shell further comprises base (1) He Kagai (2), is provided with observation panel (10) and adding mouth (12) on described Ka Gai (2), to expose the regional area of test strips; Described adding mouth (12) is opened on described sample pad (5) top, with exposed portions serve or whole described sample pad (5) zone; Described observation panel (10) is opened on described coated film (7) upside, to expose whole described detection bands (9) and described quality control band (11).
8. the reagent card of detection propepsin I according to claim 7, is characterized in that, described base (1) is plastic feet.
9. the reagent card of detection propepsin I according to claim 7, is characterized in that, described Ka Gai (2) is the plastic clip lid.
CN201320495844.9U 2013-08-14 2013-08-14 Test strip for detecting pepsinogen I and reagent card with test strip Expired - Lifetime CN203385732U (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104614530A (en) * 2014-11-20 2015-05-13 江苏省原子医学研究所 Test strip for detecting pepsinogen I and pepsinogen II as well as detection method and application of test strip
CN105467117A (en) * 2015-12-04 2016-04-06 深圳市伯劳特生物制品有限公司 Fast and quantitative PG (pepsinogen)II detection kit, production method thereof and PGII detection method
CN105548556A (en) * 2015-12-04 2016-05-04 深圳市伯劳特生物制品有限公司 PGI rapid quantitative detection kit and making method and detection method thereof
CN105891481A (en) * 2015-05-30 2016-08-24 深圳市贝沃德克生物技术研究院有限公司 Tumor early detection kit based on biomarkers and preparation method of tumor early detection kit
CN107167595A (en) * 2017-07-13 2017-09-15 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection INHB and preparation method thereof
CN107167596A (en) * 2017-07-13 2017-09-15 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection FSH and preparation method thereof
CN107192832A (en) * 2017-07-13 2017-09-22 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection AMH and preparation method thereof
CN107328942A (en) * 2017-07-13 2017-11-07 深圳市亚辉龙生物科技股份有限公司 A kind of fluorogenic quantitative detection PAPP A immunochromatography reagent bar and preparation method thereof
CN107389952A (en) * 2017-07-13 2017-11-24 深圳市亚辉龙生物科技股份有限公司 A kind of inhibin B measure kit and preparation method thereof

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104614530A (en) * 2014-11-20 2015-05-13 江苏省原子医学研究所 Test strip for detecting pepsinogen I and pepsinogen II as well as detection method and application of test strip
CN105891481A (en) * 2015-05-30 2016-08-24 深圳市贝沃德克生物技术研究院有限公司 Tumor early detection kit based on biomarkers and preparation method of tumor early detection kit
CN105467117A (en) * 2015-12-04 2016-04-06 深圳市伯劳特生物制品有限公司 Fast and quantitative PG (pepsinogen)II detection kit, production method thereof and PGII detection method
CN105548556A (en) * 2015-12-04 2016-05-04 深圳市伯劳特生物制品有限公司 PGI rapid quantitative detection kit and making method and detection method thereof
CN107167595A (en) * 2017-07-13 2017-09-15 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection INHB and preparation method thereof
CN107167596A (en) * 2017-07-13 2017-09-15 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection FSH and preparation method thereof
CN107192832A (en) * 2017-07-13 2017-09-22 深圳市亚辉龙生物科技股份有限公司 A kind of immunochromatography reagent bar of fluorogenic quantitative detection AMH and preparation method thereof
CN107328942A (en) * 2017-07-13 2017-11-07 深圳市亚辉龙生物科技股份有限公司 A kind of fluorogenic quantitative detection PAPP A immunochromatography reagent bar and preparation method thereof
CN107389952A (en) * 2017-07-13 2017-11-24 深圳市亚辉龙生物科技股份有限公司 A kind of inhibin B measure kit and preparation method thereof

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