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Triple detection chromatography test strip for human cardiac troponin I, human growth differentiation factor 15 and human D dimer and an application thereof

A growth differentiation factor, cardiac troponin technology, applied in the field of medicine, can solve problems such as poor specificity, poor repeatability, and inability to meet clinical needs

Pending Publication Date: 2021-05-18
北京赛诺浦生物技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the three joint detection kits of cTnI, CKMB and MYO cannot meet the clinical needs
Directly using its technology to prepare cTnI / GDF15 / DD triple card, there are problems of poor specificity and poor repeatability

Method used

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  • Triple detection chromatography test strip for human cardiac troponin I, human growth differentiation factor 15 and human D dimer and an application thereof
  • Triple detection chromatography test strip for human cardiac troponin I, human growth differentiation factor 15 and human D dimer and an application thereof
  • Triple detection chromatography test strip for human cardiac troponin I, human growth differentiation factor 15 and human D dimer and an application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1, Preparation of Triple Detection Chromatography Test Strips for Human Cardiac Troponin I, Human Growth Differentiation Factor 15 and Human D Dimer

[0034] 1. Experimental materials: mouse anti-human GDF-15 monoclonal antibody [23G10.F8], [7C12.B3.F2] (purchased from ABCAM Company, article number: ab105732, ab106112), mouse anti-human DD monoclonal antibody (Thermo Scientific Cat. No. ABS 015-22-02, Cat. No. ABS 015-28-02), mouse anti-human cTnI monoclonal antibody (Thermo Scientific Cat. No. MA1-20112, Cat. No. MA1-20118), nitrocellulose membrane, absorbent paper, sample pad, 6cm×30cm PVC plate, rabbit IgG (SIGMA, catalog number I5006), goat anti-rabbit IgG (Thermo Scientific, catalog number A32731) and 200nm fluorescent microspheres with carboxyl groups on the surface (1.02g / 100g, purchased from Thermo Scientific, catalog number 93470520010150), 2-(N-morpholine) ethanesulfonic acid monohydrate (MES, purchased from SIGMA Company), N-hydroxysuccinimide (NHS, p...

Embodiment 2

[0086] Example 2, Preparation of Triple Detection Chromatography Test Strips for Human Cardiac Troponin I, Human Growth Differentiation Factor 15 and Human D Dimer

[0087] Except the making of detection pad, all the other steps are identical with embodiment 1

[0088] Preparation of the detection pad:

[0089] (a) Preparation of detection line working solution

[0090] Same as Example 1, but the original coating buffer is changed to contain sodium dihydrogen phosphate 0.0296g / dL, disodium hydrogen phosphate 0.29g / dL, D trehalose 1g / dL, lauryl polyoxyethylene ether (brij-35 ) 0.1g / dL, NaCl 0.88g / dL, pH 7.3 coating buffer.

[0091] (b) Preparation of quality inspection line working fluid

[0092] Same as Example 1, but the original coating buffer is changed to contain sodium dihydrogen phosphate 0.0296g / dL, disodium hydrogen phosphate 0.29g / dL, D trehalose 1g / dL, lauryl polyoxyethylene ether (brij-35 ) 0.1g / dL, NaCl 0.88g / dL, pH 7.3 coating buffer.

[0093] (c) Preparation...

Embodiment 3

[0096] Example 3 Performance Evaluation of Chromatographic Test Strips for Triple Detection of Human Cardiac Troponin I, Human Growth Differentiation Factor 15 and Human D Dimer

[0097] 1. Experimental materials and testing equipment

[0098] Recombinant human GDF-15 (purchased from ABCAM Company, catalog number: ab50077), recombinant human cTnI (purchased from ABCAM Company, ab207624)), human DD (purchased from ABCAM Company, ab98311).

[0099] Dry fluorescence immunoassay analyzer (AFS-1000) Guangzhou Lanbo Biotechnology Co., Ltd.

[0100] 2. Detection method

[0101] Pipette 100 μl of the sample to be tested (serum, plasma) into the sample hole of the test card. Be careful not to inhale air bubbles when sampling, and place it at room temperature for 15 minutes.

[0102] Insert the test card into the test card slot rack of the fluorescence immunoassay analyzer, press the test button, the instrument will automatically scan the test card (make sure the test card is in the ...

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Abstract

The invention discloses a triple detection chromatography test strip for human cardiac troponin I (cTnI), a human growth differentiation factor 15 (GDF-15) and a human D dimer (DD) and an application thereof. The test strip comprises a bottom plate, a sample adding pad, a combination pad, a detection pad and a water absorption pad, wherein the sample adding pad, the combination pad, the detection pad and the water absorption pad are sequentially arranged on the bottom plate. Immunofluorescent microspheres for marking mouse anti-GDF-15 monoclonal antibodies, cTnI monoclonal antibodies and DD monoclonal antibodies and immunofluorescent microspheres for marking rabbit IgG are wrapped on the combination pad, monoclonal capture antibodies of mouse anti-GDF-15 monoclonal antibodies, cTnI monoclonal antibodies and DD monoclonal antibodies are wrapped on a detection line, and goat anti-rabbit IgG polyclonal antibodies are wrapped on a quality inspection line. The preparation method is improved so that the sensitivity and the specificity of the test strip for detecting three markers by adopting a fluorescent quantitative method are improved, and a new technical means is provided for detection of myocardial functions.

Description

technical field [0001] The present invention relates to a fluorescent immunochromatographic test strip and its preparation method and application, in particular to a triple detection chromatographic test strip for detecting human cardiac troponin I, human growth differentiation factor 15 and human D dimer Strips and their preparation and use. The invention belongs to the technical field of medicine. Background technique [0002] The three traditional joint tests of myocardial function (myoglobin (Myo), troponin (cTnI), and creatine kinase isoenzyme (CK-MB)) have the main advantages of rapid, quantitative, and simultaneous detection. AMI) auxiliary diagnosis and risk stratification provide great help. However, although cTnI has high sensitivity for the early diagnosis of acute myocardial infarction (AMI), its specificity is poor. increased to varying degrees. Secondly, ACS biomarkers such as troponin (cTn) and creatine kinase isoenzyme (CK-MB) still have insufficient sens...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/577G01N33/558G01N33/543G01N33/533
CPCG01N33/6893G01N33/6887G01N33/577G01N33/558G01N33/54313G01N33/533G01N2800/324G01N2333/4712G01N2333/475G01N2333/47
Inventor 李君丽朱海燕周金池王兰珍
Owner 北京赛诺浦生物技术有限公司
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