COVID19 Rapid Diagnosis Regent For Distributors

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COVID19 Rapid Diagnosis Regent For distributors
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Product Details

COVID19 Rapid Diagnosis Regent For distributors 



SARS-CoV-2 Antibody Test - Product Picture

Product nameSARS-CoV-2 Antibody Test (colloidal gold immunochromatography)

Model】 One test per bag for one person, 20 tests/kit 

Intended Use】 The product is intended for the qualitative detection of antibody  content against SARS-CoV-2 in clinical samples  (serum/plasma/whole blood).

Measurement PrincipleThe product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG  antibody immobilized in G test area, mouse-anti human IgM  antibody immobilized in M test area and the corresponding  antibody in quality control area (C). During the test, when the SARS-CoV-2 IgM antibody level in the  sample is at or above the limit of detection of the test, the  SARS-CoV-2 IgM antibody in the sample binds to the colloidal  gold labeled SARS-CoV-2 recombinant protein which is pre-coated  on a gold label pad. The conjugates migrate upward through  capillary effect and would be captured by mouse-anti human IgM  antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the  SARS-CoV-2 IgG antibody level in the sample is at or above the  limit of detection of the test, the SARS-CoV-2 IgG antibody in the  sample binds to the colloidal gold labeled SARS-CoV-2  recombinant protein which is pre-coated on a gold label pad. The  conjugates migrate upward through capillary effect and would be  captured by mouse-anti human IgG antibody immobilized in G test  area subsequently and this produces a purple-red band appears in  the G test area. If it is a negative sample, there is not a purple-red  band appeared in the M and G test area. Regardless of the presence  or absence of the SARS-CoV-2 antibody in the sample, a  purple-red band will appear in the quality control area (C). The  purple-red band in the quality control area (C) is a criterion for  judging whether there is enough sample and whether the  chromatography process is normal. It also serves as the internal  control standard for reagents



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Clinical test results of accuracy

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The Explanation of the Testing Results】 

Positive (+): There appear purple stripes in both  quality control area and either area M or G.

Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in  either test area M and test area G. Invalid: There is no purple stripe in the quality control  area (C), indicating incorrect operating procedures or  the testing strip has already deteriorated. Under this  conditions, it must read the instruction for use again  carefully, and then use the new test strips to test again.  If the problem still exists, stop using this lot number  immediately and contact the local suppliers.

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Certificates

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Meanwhile, on 26th April 2020, Lepu Medical SARS-CoV-2 Antibody Test Kit went white listed officially by Chinese Commerce Ministry, please refer to the link, http://www.cccmhpie.org.cn/Pub/6325/176181.shtml , section "Coronavirus Reagent Test kits" Number 9.

Welcome to consult for more information!



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