CN201087838Y - Myocardium calcium protein I color particle diagnosis test paper - Google Patents

Myocardium calcium protein I color particle diagnosis test paper Download PDF

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Publication number
CN201087838Y
CN201087838Y CNU200720140929XU CN200720140929U CN201087838Y CN 201087838 Y CN201087838 Y CN 201087838Y CN U200720140929X U CNU200720140929X U CN U200720140929XU CN 200720140929 U CN200720140929 U CN 200720140929U CN 201087838 Y CN201087838 Y CN 201087838Y
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China
Prior art keywords
colored particle
particle
test paper
calcium protein
myocardium calcium
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Expired - Lifetime
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CNU200720140929XU
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Chinese (zh)
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万志静
万志强
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WHPM Bioresearch and Technology Co Ltd
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WHPM Bioresearch and Technology Co Ltd
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Abstract

The utility model relates to a diagnosis test paper used for cardiac troponin 1 which is a diagnosis test paper used for qualitatively detecting the cardiac troponin 1 in a clinical sample (whole blood/serum/plasma) by quick immuno-chromatography, and belongs to the quick detecting field of the immunity-chromatography. The utility model is composed of a bottom plate, a water absorption plate, a nitrocellulose membrane, a colored particle fixation pad, a sample imbibition layer and a MAX line. The middle part of the bottom plate is the nitrocellulose membrane which is provided with a cardiac troponin 1 monoclonal antibody test line and a sheep anti mouse polyclonal antibody control line. The end of one end of the bottom plate is the water absorption plate, and the end of the other end of the bottom plate is the sample imbibition layer. Both ends of the nitrocellulose membrane are respectively and overlappedly connected with the water absorption plate and the colored particle fixation pad, and the sample imbibition layer is pressed on the colored particle fixation pad.

Description

Myocardium calcium protein I colored particle diagnose test paper
Technical field
The present invention relates to a kind of myocardium calcium protein I colored particle diagnose test paper, belong to immunochromatography fast detecting field.
Background technology
Troponin is made of Troponin I, T, C three subunits, and they and tropomyosin are together by regulating Ca 2+Come modulate actin and myosin to interact to the activity of striated muscle filamentous actin ATP enzyme.After myocardial damage, the cardiac troponin compound is discharged in the blood, and after 4-6 hour, beginning raises in blood, and the Troponin I of rising can keep for a long time (6-10 days) in blood, and long detection period so just is provided.And cardiac muscle troponin I has the myocardium specificity and the sensitivity of height, so cardiac muscle troponin I has become present optimal myocardial infarction mark.
Myocardium calcium protein I routine inspection method has radioimmunoassay method (RIAs), high pressure liquid chromatographic analysis method, Biochemical Analyzer, protein analyzer and various diagnostic kits etc., these methods exist needs professional instrument, length consuming time or shortcoming such as seriously polluted, in clinical use certain limitation is arranged, be not easy to apply.
Summary of the invention
The utility model has overcome some problems that exist in the prior art, a kind of fast immune chromatographic method of utilizing is provided, detect the diagnose test paper of clinical samples (whole blood/blood serum) center Troponin I qualitatively, be a kind of supplementary means that heart diseases such as miocardial infarction, acute coronary artery syndrome are detected, only be used for in-vitro diagnosis.
For solving the problems of the technologies described above, the present invention is achieved by the following technical solutions:
Myocardium calcium protein I colored particle diagnose test paper is made up of base plate, water sucting plate, nitrocellulose filter, colored particle fixed bolster, sample liquid-adsorption layer, MAX line.The base plate middle part is a nitrocellulose filter, unite as one on the nitrocellulose filter Troponin I monoclonal antibody test wire and a sheep anti mouse polyclonal antibody control line, in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
Wherein colored particle can be a kind of metal colloid particles, can comprise colloid gold particle, silver-colored particle, iron particle, magnetic-particle etc., a kind of marking particle can comprise dye granule, latex particle, fluorescent grain etc., can realize sxemiquantitative or full detection by quantitative when adopting magnetic-particle.
The sample liquid-adsorption layer is made up of trilaminate material stack, and ground floor is that certain specification nonwoven layer, the second layer are that glass layer, the 3rd layer are the certain specification nonwoven layer, and above-mentioned substance all need pass through surfactant damping fluid immersion treatment, and drying is afterwards standby.
During detection, collect sample in clean sample cup, the sampling end of test paper is put into detection sample (liquid level must not surpass the MAX line) because the capillarity test sample will move to the water sucting plate end along test strips, sample center Troponin I antigen can move and the antibodies that is coated on the nitrocellulose filter with continuation after the anti-myocardium calcium protein I labeling of monoclonal antibody probe generation specific bond, thereby by anti-myocardium calcium protein I monoclonal antibody identification, the specific bond of double antibodies sandwich takes place.In the testing process, will show corresponding redness when up liquid level promptly is stranded in this regional label probe, it is positive two red lines to occur, a red line occurs and is expressed as negative findings.
When moving to sheep anti mouse polyclonal antibody control line, no matter sample center Troponin I content has or not, and label probe all can combine delay with the sheep anti-mouse igg of bag quilt on the nitrocellulose filter, and it is red that control line is shown.So control line does not have, and colour band produces then representative operation wrong (during detection, the sample liquid level surpasses the MAX line) or test paper is expired.
Because adopt technique scheme, myocardium calcium protein I colored particle diagnose test paper provided by the present invention has such beneficial effect: i.e. high specificity, highly sensitive, easily store, need not the technical skill personnel operation, do not need instrument and equipment, and readability as a result.
Description of drawings
Fig. 1 is the main TV structure figure of myocardium calcium protein I colored particle diagnose test paper.
Fig. 2 is the plan structure figure of myocardium calcium protein I colored particle diagnose test paper.
Fig. 3 is the positive findings figure of myocardium calcium protein I colored particle diagnose test paper.
Fig. 4 is the negative findings figure of myocardium calcium protein I colored particle diagnose test paper.
Among the figure 1, water sucting plate, 2, nitrocellulose filter, 3, sheep anti mouse polyclonal antibody control line, 4, test wire, 5, the colored particle fixed bolster, 6, the sample liquid-adsorption layer, 7, base plate, 8, the MAX line.
Specific embodiment
Shown in Fig. 1~4, myocardium calcium protein I colored particle diagnose test paper is by base plate (7), water sucting plate (1), nitrocellulose filter (2), colored particle fixed bolster (5), sample liquid-adsorption layer (6), MAX line (8) is formed, the base plate middle part is a nitrocellulose filter, the Troponin I monoclonal antibody of uniting as one on a nitrocellulose filter test wire (4) and a sheep anti mouse polyclonal antibody control line (3), in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
1. the preparation of synthetic immunogen: with the myocardium calcium protein I synthetic immunogen of the synthetic two kinds of different binding sites of chemical synthesis process;
2. MONOCLONAL ANTIBODIES SPECIFIC FOR: the myocardium calcium protein I synthetic immunogen of two kinds of different binding sites that will prepare is immune BALB/c mouse respectively.Set up the knurl strain with the SP20 Fusion of Cells and screen, get oncocyte and be injected in the BALB/c mouse abdominal cavity, make it produce ascites.Extract the screening of mouse ascites purifying, obtain the two kinds of myocardium calcium protein I monoclonal antibody I, the myocardium calcium protein I monoclonal antibody II that combine with myocardium calcium protein I molecule different loci.Wherein myocardium calcium protein I monoclonal antibody I is used for test wire bag quilt, and myocardium calcium protein I monoclonal antibody II is used for colored particle to be fixed.
3. combining of colored particle and myocardium calcium protein I monoclonal antibody: the colored particle of myocardium calcium protein I monoclonal antibody II mark is adsorbed onto on the fibrous material, and dry back is standby.
4. film-making machine system film: utilize computer control transmission speed, guarantee that the antibody amount of bag quilt on the per unit film equates.
5. test strips combination: press the known technology combination.
6. using method:
Gather whole blood (venous blood or finger tip blood), serum or blood plasma.As use whole blood sample, please use immediately.Sample should not placed at ambient temperature for a long time.As use the blood serum sample to detect, and should isolate serum or blood plasma as early as possible, avoid haemolysis.The sample of haemolysis can not use.The venous blood sample can be preserved two days under 2-8 ℃ of condition, can not be freezing.Serum or plasma specimen can be preserved two days under 2-8 ℃ of condition.Need freezing (20 ℃) as long preservation.Avoid multigelation.
Collect sample in clean sample cup, test paper liquid-adsorption layer end is inserted in the sample, the sample to be tested interface does not surpass " MAX " line on the diagnose test paper, observations in 10~15 minutes.The colour developing district is two red line, and then testing result is positive; Negative when a control line only occurring; Colour band does not appear in control line, shows the expired or misoperation of test paper, please gets test paper in addition and detects again.

Claims (7)

1. myocardium calcium protein I colored particle diagnose test paper, it is characterized in that it is by base plate (7), water sucting plate (1), nitrocellulose filter (2), colored particle fixed bolster (5), sample liquid-adsorption layer (6), MAX line (8) is formed, the base plate middle part is a nitrocellulose filter, the Troponin I monoclonal antibody of uniting as one on a nitrocellulose filter test wire (4) and a sheep anti mouse polyclonal antibody control line (3), in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
2. myocardium calcium protein I colored particle diagnose test paper according to claim 1 is characterized in that colored particle is a kind of metal colloid particles.
3. myocardium calcium protein I colored particle diagnose test paper according to claim 2 is characterized in that metal colloid particles comprises colloid gold particle, silver-colored particle, iron particle, magnetic-particle.
4. myocardium calcium protein I colored particle diagnose test paper according to claim 1, it is characterized in that the sample liquid-adsorption layer is made up of trilaminate material stack, ground floor is that certain specification nonwoven layer, the second layer are that glass layer, the 3rd layer are the certain specification nonwoven layer.
5. myocardium calcium protein I colored particle diagnose test paper according to claim 1 is characterized in that being coated with on the nitrocellulose filter two lines, a test wire, a control line.
6. myocardium calcium protein I colored particle diagnose test paper according to claim 1 is characterized in that colored particle is a kind of marking particle.
7. myocardium calcium protein I colored particle diagnose test paper according to claim 6 is characterized in that marking particle comprises dye granule, latex particle, fluorescent grain.
CNU200720140929XU 2007-03-30 2007-03-30 Myocardium calcium protein I color particle diagnosis test paper Expired - Lifetime CN201087838Y (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102087293A (en) * 2010-12-31 2011-06-08 广州万孚生物技术有限公司 Immunochromatographic test strip for quantitatively detecting troponin I in whole course and preparation method thereof
CN102207507A (en) * 2011-03-24 2011-10-05 武汉璟泓万方堂医药科技有限公司 Semi-quantitative detecting test paper of cardiac troponin and preparation method thereof
CN102257391A (en) * 2008-12-22 2011-11-23 皇家飞利浦电子股份有限公司 Assay for troponin i using magnetic labels
CN102662055A (en) * 2012-04-28 2012-09-12 广州鸿琪光学仪器科技有限公司 Immune fluorescent test strip component for quickly quantitatively detecting troponin I, detection card component comprising immune fluorescent test strip component and preparation methods for immune fluorescent test strip component and detection card component
CN102680697A (en) * 2011-03-10 2012-09-19 北京吉奥众艺科技有限公司 Reagent kit for detecting troponin I and preparation and use method thereof
CN103217535A (en) * 2013-03-18 2013-07-24 杭州德安奇生物工程有限公司 Immunochromatography detection card for detecting troponin I

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102257391A (en) * 2008-12-22 2011-11-23 皇家飞利浦电子股份有限公司 Assay for troponin i using magnetic labels
CN102087293A (en) * 2010-12-31 2011-06-08 广州万孚生物技术有限公司 Immunochromatographic test strip for quantitatively detecting troponin I in whole course and preparation method thereof
CN102680697A (en) * 2011-03-10 2012-09-19 北京吉奥众艺科技有限公司 Reagent kit for detecting troponin I and preparation and use method thereof
CN102680697B (en) * 2011-03-10 2015-11-25 王迎峰 Detect kit and the preparation and application thereof of Troponin I
CN102207507A (en) * 2011-03-24 2011-10-05 武汉璟泓万方堂医药科技有限公司 Semi-quantitative detecting test paper of cardiac troponin and preparation method thereof
CN102662055A (en) * 2012-04-28 2012-09-12 广州鸿琪光学仪器科技有限公司 Immune fluorescent test strip component for quickly quantitatively detecting troponin I, detection card component comprising immune fluorescent test strip component and preparation methods for immune fluorescent test strip component and detection card component
CN102662055B (en) * 2012-04-28 2014-12-10 广州鸿琪光学仪器科技有限公司 Immune fluorescent test strip component for quickly quantitatively detecting troponin I, detection card component comprising immune fluorescent test strip component and preparation methods for immune fluorescent test strip component and detection card component
CN103217535A (en) * 2013-03-18 2013-07-24 杭州德安奇生物工程有限公司 Immunochromatography detection card for detecting troponin I

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Granted publication date: 20080716