CN204989196U - Qualitative test paper strip of immunity chromatography is united to six antinuclear antibodiess - Google Patents

Qualitative test paper strip of immunity chromatography is united to six antinuclear antibodiess Download PDF

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CN204989196U
CN204989196U CN201520584866.1U CN201520584866U CN204989196U CN 204989196 U CN204989196 U CN 204989196U CN 201520584866 U CN201520584866 U CN 201520584866U CN 204989196 U CN204989196 U CN 204989196U
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antibody
pad
fluorescent marker
test strips
sample pad
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裘宇容
吴淡娟
陈泳钗
王小明
夏坤
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Guangzhou Tianbao Songyuan Biology Science & Technology Development Co Ltd
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Guangzhou Tianbao Songyuan Biology Science & Technology Development Co Ltd
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Abstract

The utility model discloses a qualitative test paper strip of immunity chromatography is united to six antinuclear antibodiess, combine pad, nitrocellulose membranes and the pad that absorbs water including bottom plate, sample pad, fluorescent label thing, the test paper strip is combined pad, nitrocellulose membranes, is absorbed water by sample pad, fluorescent label thing and fills up in proper order the overlap joint and paste and constitute on the bottom plate. The fluorescent label thing combines to fill up the mouse -anti people igG polyclonal antibody who contains streptavidin mark fluorescin and biotin mark, the cellulose nitrate is epimembranal to have detection line and matter accuse line, and 52 -kD roSSA antibody, rRNP antibody, jo -1 antibody, smD1 antibody, sc1 -70 antibody and SSB -La antibody can be discerned to the detection line. The utility model discloses not only shortened check -out time greatly, improved detectivity, jointly detected simultaneously and still improved the convenience greatly.

Description

Antinuclear antibodies six combined immunization chromatography qualitative detection test strips
Technical field
The utility model belongs to field of immunodetection, is specifically related to a kind of high sensitivity antinuclear antibodies six combined immunization chromatography qualitative detection test strips.
Background technology
Autoimmune disease (AutoimmuneDiseases, AID) be general reference immunity of organism effector cell or immune effector molecule, abnormal immune responsing reaction is there is for autologous tissue or cell, cause tissue damage or handicapped disease, that a class incidence of disease is high, can whole body system be attacked, serious harm human health, disease that disability rate, fatal rate are high.Such disease feature is the lymphocyte that there is autoantibody and (or) sensitization in blood; Injuries of tissues and organs and dysfunction scope depend on that autoantigen distributes; Patient is more common with women, and the incidence of disease increases with the growth at age; Most protopathy cause of disease is unclear, often presents genetic predisposition; The chronic delay of the course of disease and recurrent exerbation, even become lifelong chronic illness; Immuno-suppressive medication has certain curative effect.
In the various test items of AID disease, because antinuclear antibodies (ANA) is closely related with AID, be the important target position of autoimmune response, therefore antinuclear antibodies detects be in critical positions always in AID disease, is the extremely important shaker test of clinical the next item up.Along with the continuous intensification of people's understanding, the definition of antinuclear antibodies (Antinuclearantibody, ANA) expands to present whole cell by originally traditional for nucleus, refers to the general name of the autoantibody of all antigenic components in anti-cell.30 various ANA with different clinical meaning are found at present, common as Anti-hCG action and anti-Sm antibody be the significant antibody of systemic loupus erythematosus, anti-SS-A (Ro) antibody and anti-SS-B (La) antibody then more comes across dry syndrome patient etc.The detection of ANA clinically, actually refers to that total antinuclear antibodies detects.The disease of the ANA positive is a lot, and in common AID disease, the positive rate of the ANA of Patients with SLE is about 90-100%, and dry syndrome patient positive rate is about 60-80%, and the ANA positive rate of patient with rheumatoid arthritis is 30-50%.Because ANA just can exist before obvious clinical symptoms appears in AID disease, and its titre declines gradually after stable disease, therefore ANA detection for AID disease early screening, diagnosis and differential diagnosis, the judgement of disease activity and the observation of result for the treatment of and instruct the aspects such as clinical application to have great importance.
Detection method conventional at present mainly contains two kinds, is namely prefered method-indirect immunofluorescence (IIF) and ELISA method as detecting " goldstandard ".IIF method is routine clinical shaker test always, although the method detection sensitivity is high, but need manual operations and microscopic examination, influence factor is more, especially experience does not enrich the easy misjudgment of person, and because the running time is long, often adopts batch detection clinically, thus also often occur just going out situation about once reporting in one week or two weeks, be unfavorable for the early diagnosis of disease.EILSA method, because carrying out half-quantitative detection, whether the improvement of the clinical frequent judgement of the change according to its concentration patient, thus formulate next step therapeutic scheme, therefore uses widely clinical have also been obtained.Because ELISA method is also batch detection, therefore also exist when specimen amount lacks and can not go out result during pole, kit length standing time opening packaging easily affects testing result thus affects the shortcoming of clinical diagnosis and treatment.The clinical diagnose pathway of AID disease, normally first carries out ANA examination, if negative and substantially can get rid of AID without obvious clinical symptoms, otherwise the patient of the ANA positive then needs the confirmation experiment carrying out target antibody further, thus further determines the kind of disease.But IIF method and EILSA method, all exist Turnaround Time long, the result time is long to cause patient to wait for, delays the instant hospitalizing of patient, thus affects diagnosis of disease situation.
For the problem of above-mentioned clinical existence, at the POCT (PointOfCareTesting) that current laboratory medicine development proposes, namely under real-time test frontier background, be devoted to develop a kind of new detection reagent and fluorescence immune chromatography quick detection kit, small fluorescent immunity analysis instrument is used to detect, spended time was at about 15 minutes, therefore simple, convenient, namely sample arrives and namely examines, the problem of patient's stand-by period length can be solved, the routing problem that clinician performs autoimmune disease clinical diagnosis can be solved again, can use at clinical expansion, to improve the treatment level of autoimmune disease.
Anti-52-kDRo/SSA antibody, anti-rRNP antibody, anti-Jo-1 antibody, Anti-SmD1 antibody, Anti-Scl-70, anti-SSB-La antibody is the significant antibody of clinical common several autoimmune diseases, and the paving that six joint-detection may be used for autoimmune disease helps diagnosis.
Utility model content
The purpose of this utility model, be to provide a kind of antinuclear antibodies six combined immunization chromatography qualitative detection test strips, it is based on indirect method, fluorescence immunoassay lateral chromatography and biotin-Streptavidin amplification system, provides high sensitivity antinuclear antibodies six combined immunization chromatography qualitative detection test strips.When using the utility model, improve detection sensitivity and detect stability, reduce non-specific binding, joint-detection increases substantially accuracy and the convenience of detection, and detection time, at about 15 minutes, substantially increases diagnosis efficiency.
The solution that the utility model solves its technical matters is: antinuclear antibodies six combined immunization chromatography qualitative detection test strips, it comprises base plate, described base plate is provided with sample pad successively, fluorescent marker pad, nitrocellulose filter and adsorptive pads, described adsorptive pads and fluorescent marker pad are overlapping to be respectively pressed in behind the two ends of nitrocellulose filter in the formation detection zone, surface of nitrocellulose filter, described sample pad is overlapping to be pressed on fluorescent marker pad, described fluorescent marker pad is fixed with the fluorescin of biotin labeled mouse-anti human IgG polyclonal antibody and marked by streptavidin, nitrocellulose filter in described detection zone is fixed with the nature controlling line that the first detection line identifying anti-52-kDRo/SSA antibody, the second detection line identifying anti-rRNP antibody, the 3rd detection line identifying anti-Jo-1 antibody, the 4th detection line identifying Anti-SmD1 antibody, the 5th detection line identifying Anti-Scl-70, the 6th detection line identifying anti-SSB-La antibody and sheep anti-mouse igg polyclonal antibody are formed.
As the further improvement of technique scheme, described fluorescent marker pad comprises the first stacked fluorescent marker pad and the second fluorescent marker pad, one end pad of described first fluorescent marker pad in the below of sample pad, described second overlapping one end being pressed in nitrocellulose filter of fluorescent marker pad.
As the further improvement of technique scheme, in described first fluorescent marker pad, the one end of inserting below sample pad is provided with positioning strip, and the lower surface of described sample pad is provided with the locating slot that can hold positioning strip.
As the further improvement of technique scheme, also comprise and getting stuck, in described base plate, sample pad, fluorescent marker pad, nitrocellulose filter and adsorptive pads are all placed in and get stuck, the position described shell face of getting stuck corresponding to nitrocellulose membrane is provided with view window, and position shell face of getting stuck corresponding to sample pad is provided with well.
As the further improvement of technique scheme, described view window is slot.
As the further improvement of technique scheme, described fluorescin can be the one in green fluorescent protein, phycobniliprotein.
As the further improvement of technique scheme, described sample pad is glass fibre component dry after surfactant damping fluid immersion treatment.
As the further improvement of technique scheme, described base plate is polystyrene component or tygon component.
As the further improvement of technique scheme, described in get stuck and comprise plastics upper casing and plastics lower casing, described plastics upper casing fastens to be formed after on plastics lower casing and gets stuck.
Compared with prior art, tool has the following advantages the utility model:
(1) the utility model is using fluorescin as label, and this label has good stability, and is conducive to improving detecting stability.
(2) the utility model is by utilizing " Streptavidin-biotin amplification system ", improves detection sensitivity, reduces non-specific binding, is conducive to improving kit performance.
(3) utilize the utility model to carry out the detection time of sample at about 15 minutes, drastically increase detection efficiency.
(4) the utility model carries out interpretation by fluorescence immunity analyzer to result, can realize robotization, reduces the impact of subjective factor, provides convenient, quick, reliable diagnostic result.
(5) the utility model gets stuck and is provided with the well that sample enters and the view window supplying observed result, according to analytical instrument result of determination, accurately and reliably.
(6) the utility model is easy to make, and volume is little, be easy to carry.
(7) the utility model testing cost is lower.
(8) the utility model can be mass, and is applicable to clinical quick diagnosis and on-the-spot quick diagnosis; Be easy to preserve, be conducive to grass-roots unit and promote.
(9) the utility model adopts joint-detection, and a detector bar detects six simultaneously, detects convenient.
Accompanying drawing explanation
In order to be illustrated more clearly in the technical scheme in the utility model embodiment, below the accompanying drawing used required in describing embodiment is briefly described.Obviously, described accompanying drawing is a part of embodiment of the present utility model, instead of whole embodiment, and those skilled in the art, under the prerequisite not paying creative work, can also obtain other design proposals and accompanying drawing according to these accompanying drawings.
Fig. 1 is the structural representation of the utility model embodiment one;
Fig. 2 is the structural representation of the utility model embodiment two;
Fig. 3 is the structural representation of the utility model embodiment three;
Fig. 4 is the structural representation of the utility model embodiment four.
Embodiment
Be clearly and completely described below with reference to embodiment and the accompanying drawing technique effect to design of the present utility model, concrete structure and generation, to understand the purpose of this utility model, characteristic sum effect fully.Obviously; described embodiment is a part of embodiment of the present utility model, instead of whole embodiment, based on embodiment of the present utility model; other embodiments that those skilled in the art obtains under the prerequisite not paying creative work, all belong to the scope of the utility model protection.In addition, all connection/annexations mentioned in literary composition, not singly refer to that component directly connects, and refer to and according to concrete performance, can connect auxiliary by adding or reducing, and form more excellent draw bail.
With reference to Fig. 1, anti-SSB-La antibody immune chromatography quantitative testing test paper bar, it comprises base plate 5, described base plate 5 is provided with sample pad 1 successively, fluorescent marker pad 2, nitrocellulose filter 3 and adsorptive pads 4, described adsorptive pads 4 and fluorescent marker pad 2 are overlapping to be respectively pressed in behind the two ends of nitrocellulose filter 3 in the formation detection zone, surface of nitrocellulose filter 3, fluorescent marker pad 2 is glass fibre membrane, described sample pad 1 is overlapping to be pressed on fluorescent marker pad 2, the fluorescin described fluorescent marker pad 2 being fixed with biotin labeled mouse-anti human IgG polyclonal antibody (concentration 0.3 ~ 1.5mg/mL) and marked by streptavidin (or Avidin) (uses excitation wavelength 530nm, wavelength of transmitted light 570nm, concentration 0.1 ~ 2.0mg/mL), nitrocellulose filter 3 in described detection zone is fixed with the first detection line T1 (concentration 0.5 ~ 3mg/mL) identifying anti-52-kDRo/SSA antibody, identify the second detection line T2 (concentration 0.5 ~ 3mg/mL) of anti-rRNP antibody, identify the 3rd detection line T3 (concentration 0.5 ~ 3mg/mL) of anti-Jo-1 antibody, identify the 4th detection line T4 (concentration 0.5 ~ 3mg/mL) of Anti-SmD1 antibody, identify the 5th detection line T5 (concentration 0.5 ~ 3mg/mL) of Anti-Scl-70, identify the 6th detection line T6 (concentration 0.5 ~ 3mg/mL) of anti-SSB-La antibody and the nature controlling line C (concentration 0.2 ~ 2.0mg/mL) of sheep anti-mouse igg polyclonal antibody formation, nature controlling line C is used for the validity of test strip.
The fluorescin that biotin labeled mouse-anti human IgG polyclonal antibody and Streptavidin (or Avidin) mark is fixed on fluorescent marker pad 2, using identify anti-52-kDRo/SSA antibody antigen, identify anti-rRNP antibody antigen, identify anti-Jo-1 antibody antigen, identify Anti-SmD1 antibody antigen, identify Anti-Scl-70 antigen, identify that the antigen of anti-SSB-La antibody mixes and be fixed on as detection line on nitrocellulose filter, sheep anti-mouse igg polyclonal antibody is fixed on nitrocellulose filter as nature controlling line C.When testing sample is added to after in sample pad 1, moved forward by chromatography effect, anti-52-kDRo/SSA antibody in sample, anti-rRNP antibody, anti-Jo-1 antibody, Anti-SmD1 antibody, Anti-Scl-70, on anti-SSB-La antibody and fluorescent marker pad 2, the mouse-anti human IgG polyclonal antibody (Pab*Fluoro) of combined with fluorescent label (fluorescin) reacts and forms compound Mab-52-kDRo/SSA-Pab*Fluoro, Mab-rRNP-Pab*Fluoro, Mab-Jo-1-Pab*Fluoro, Mab-SmD1-Pab*Fluoro, Mab-Scl-70-Pab*Fluoro, Mab-SSB-La-Pab*Fluoro, reacts compound and continues to be advanced past 52-kDRo/SSA antigen nitrocellulose membrane wrapping quilt under chromatography effect, rRNP antigen, Jo-1 antigen, SmD1 antigen, Scl-70 antigen, time SSB-La antigen (detection line), the 52-kDRo/SSA antigen that reaction compound is corresponding coated respectively, rRNP antigen, Jo-1 antigen, SmD1 antigen, Scl-70 antigen, SSB-La antigen capture forms compound (52-kDRo/SSA-Mab-52-kDRo/SSA-Pab*Fluoro, rRNP-Mab-rRNP-Pab*Fluoro, Jo-1-Mab-Jo-1-Pab*Fluoro, SmD1-Mab-SmD1-Pab*Fluoro, Scl-70-Mab-Scl-70-Pab*Fluoro, SSB-La-Mab-SSB-La-Pab*Fluoro) (detection line), the reaction signal of detection line is read by fluorescence immunity analyzer, under the effect of excitation source, fluorescent material launches the fluorescence signal of specific wavelength, and fluorescence immunity analyzer captures fluorescence signal, obtain anti-52-kDRo/SSA antibody, anti-rRNP antibody, anti-Jo-1 antibody, Anti-SmD1 antibody, Anti-Scl-70, the testing result of anti-SSB-La antibody.
As the further improvement of technique scheme, with reference to Fig. 3, described fluorescent marker pad 2 comprises the first stacked fluorescent marker pad 20 and the second fluorescent marker pad 21, one end pad of described first fluorescent marker pad 20 in the below of sample pad 1, described second overlapping one end being pressed in nitrocellulose filter 3 of fluorescent marker pad 21.The layering of fluorescent marker pad 2 is arranged, and is convenient to fluorescent marker pad 2 to be arranged between sample pad 1 and nitrocellulose filter 3.
As the further improvement of technique scheme, be provided with positioning strip 22 with reference to one end of inserting below sample pad in the first fluorescent marker pad 20 described in Fig. 3, the lower surface of described sample pad 1 is provided with the locating slot that can hold positioning strip 22.The installation be convenient between fluorescent marker pad 2 and sample pad 1 by positioning strip 22 is fixed.
As the further improvement of technique scheme, with reference to Fig. 2 and Fig. 4, also comprise and getting stuck, described base plate 5, sample pad 1, fluorescent marker pad 2, nitrocellulose filter 3 and adsorptive pads 4 are all placed in and get stuck in 6, the position described 6 shell faces of getting stuck corresponding to nitrocellulose membrane 3 is provided with view window 8, and the position 6 shell faces of getting stuck corresponding to sample pad 1 is provided with well 7.
As the further improvement of technique scheme, described view window 8 is slot.
As the further improvement of technique scheme, described fluorescin can be the one in green fluorescent protein, phycobniliprotein.
As the further improvement of technique scheme, described sample pad 1 is glass fibre component dry after surfactant damping fluid immersion treatment.Sample pad is made up of glass fibre, through surfactant damping fluid immersion treatment, uses after dry.The cutting width of described sample pad 1 is 2.5 ~ 5.0mm.
As the further improvement of technique scheme, described base plate 5 is polystyrene component or tygon component.
As the further improvement of technique scheme, described in get stuck and 6 comprise plastics upper casing 60 and plastics lower casing 61, described plastics upper casing 60 fastens to be formed after on plastics lower casing 61 and gets stuck 6.
More than that better embodiment of the present utility model is illustrated, but the invention is not limited to described embodiment, those of ordinary skill in the art also can make all equivalent modifications or replacement under the prerequisite without prejudice to the utility model spirit, and these equivalent modification or replacement are all included in the application's claim limited range.

Claims (9)

1. antinuclear antibodies six combined immunization chromatography qualitative detection test strips, it is characterized in that: it comprises base plate, described base plate is provided with successively sample pad, fluorescent marker pad, nitrocellulose filter and adsorptive pads, described adsorptive pads and fluorescent marker pad are overlapping to be respectively pressed in behind the two ends of nitrocellulose filter in the formation detection zone, surface of nitrocellulose filter, described sample pad is overlapping to be pressed on fluorescent marker pad, described fluorescent marker pad is fixed with the fluorescin of biotin labeled mouse-anti human IgG polyclonal antibody and marked by streptavidin; Nitrocellulose filter in described detection zone is fixed with the nature controlling line that the first detection line identifying anti-52-kDRo/SSA antibody, the second detection line identifying anti-rRNP antibody, the 3rd detection line identifying anti-Jo-1 antibody, the 4th detection line identifying Anti-SmD1 antibody, the 5th detection line identifying Anti-Scl-70, the 6th detection line identifying anti-SSB-La antibody and sheep anti-mouse igg polyclonal antibody are formed.
2. antinuclear antibodies according to claim 1 six combined immunization chromatography qualitative detection test strips, it is characterized in that: described fluorescent marker pad comprises the first stacked fluorescent marker pad and the second fluorescent marker pad, one end pad of described first fluorescent marker pad in the below of sample pad, described second overlapping one end being pressed in nitrocellulose filter of fluorescent marker pad.
3. antinuclear antibodies according to claim 2 six combined immunization chromatography qualitative detection test strips, it is characterized in that: in described first fluorescent marker pad, the one end of inserting below sample pad is provided with positioning strip, and the lower surface of described sample pad is provided with the locating slot that can hold positioning strip.
4. six the combined immunization chromatography qualitative detection test strips of the antinuclear antibodies according to any one of claims 1 to 3, it is characterized in that: also comprise and getting stuck, in described base plate, sample pad, fluorescent marker pad, nitrocellulose filter and adsorptive pads are all placed in and get stuck, the position described shell face of getting stuck corresponding to nitrocellulose membrane is provided with view window, and position shell face of getting stuck corresponding to sample pad is provided with well.
5. antinuclear antibodies according to claim 4 six combined immunization chromatography qualitative detection test strips, is characterized in that: described view window is slot.
6. antinuclear antibodies according to claim 4 six combined immunization chromatography qualitative detection test strips, is characterized in that: described fluorescin can be the one in green fluorescent protein, phycobniliprotein.
7. antinuclear antibodies according to claim 4 six combined immunization chromatography qualitative detection test strips, is characterized in that: described sample pad is glass fibre component dry after surfactant damping fluid immersion treatment.
8. antinuclear antibodies according to claim 4 six combined immunization chromatography qualitative detection test strips, is characterized in that: described base plate is polystyrene component or tygon component.
9. antinuclear antibodies according to claim 4 six combined immunization chromatography qualitative detection test strips, is characterized in that: described in get stuck and comprise plastics upper casing and plastics lower casing, described plastics upper casing fastens to be formed after on plastics lower casing and gets stuck.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105911276A (en) * 2016-07-12 2016-08-31 中国人民解放军南京军区福州总医院 Seven-link gold label detection card and preparation method thereof
CN106802350A (en) * 2017-03-11 2017-06-06 中国海洋大学 A kind of pathogenicity fish enteron aisle vibrios quick detection test paper
CN107727869A (en) * 2017-10-12 2018-02-23 上海川至生物技术有限公司 Kit of antinuclear antibodies and preparation method thereof in a kind of measure serum
CN111413506A (en) * 2018-01-30 2020-07-14 深圳市伯劳特生物制品有限公司 Application of detection test strip in preparation of kit for detecting P L A2R antibody
CN111413501A (en) * 2018-01-30 2020-07-14 深圳市伯劳特生物制品有限公司 Application of detection test strip in preparation of kit for detecting THSD7A antibody

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105911276A (en) * 2016-07-12 2016-08-31 中国人民解放军南京军区福州总医院 Seven-link gold label detection card and preparation method thereof
CN106802350A (en) * 2017-03-11 2017-06-06 中国海洋大学 A kind of pathogenicity fish enteron aisle vibrios quick detection test paper
CN106802350B (en) * 2017-03-11 2019-02-26 中国海洋大学 A kind of pathogenicity fish enteron aisle vibrios quick detection test paper
CN107727869A (en) * 2017-10-12 2018-02-23 上海川至生物技术有限公司 Kit of antinuclear antibodies and preparation method thereof in a kind of measure serum
CN111413506A (en) * 2018-01-30 2020-07-14 深圳市伯劳特生物制品有限公司 Application of detection test strip in preparation of kit for detecting P L A2R antibody
CN111413501A (en) * 2018-01-30 2020-07-14 深圳市伯劳特生物制品有限公司 Application of detection test strip in preparation of kit for detecting THSD7A antibody

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