【Product name】 SARS-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 Principle】 The 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
Clinical test results of accuracy
【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.
Certificates
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.c
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