What is a COVID-19 IgM-IgG Rapid Test?
Panodyne Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
How does the COVID-19 Rapid Test Work?
The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.
How quickly can COVID-19 Rapid Test yield results?
Results are valid 15 minutes after sample and buffer are combined in the cassette sample well.
What do the results tell me?
A total of three detection lines are possible, with the control (C) line appearing when the sample has flowed through the cassette.1. Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
2. Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
3. Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
4. Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies
How accurate is the COVID-19 Rapid Test?
In order to test the detection sensitivity and specificity of the COVID-19 IgG-IgM combined antibody test, blood samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 525 cases were tested: 397 (positive) clinically confirmed (including PCR test) Covid-19-infected patients and 128 non-Covid-19-infected patients (128 negative). The testing results of vein blood without viral inactivation were summarized in the Table 1. Of the 397 blood sample from Covid-19-infected patients, 352 tested positive, resulting in a sensitivity of 88.66%. Twelve of the blood samples from the 128 non-Covid-19 infection patients tested positive, generating a specificity of 90.63%.
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