COVID-19 IgM/IgG Rapid Test Kits
Now Available for YOUR Medical Practice

Steps:

1. Collect blood/serum/plasma sample.
2. Add blood/serum/plasma sample to sample well.
3. Place 2-3 drops of buffer in sample well.
4. Read results after 10 minutes and no more than 15 minutes.

Results:

The Hangzhou ClunGene Biotech Rapid Test provides accurate COVID-19 infection diagnosis in 10-15 minutes.

It is widely accepted that IgM provides the first line of defense during viral infections, follwed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection.

Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection. Results B

Is the COVID-19 IgM-IgG Rapid Test availabe in the US?

On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updates include guidance for commercial manufacturers for serology test that identify antibodies (e.g., IgM, IgG) to CoVID-19 from clinical specimens. The policy allows testing in laboratories or by healthcare workers at the Point-of-Care. The policy does not apply to at-home testing.

How quickly can COVID-19 Rapid Test yield results?

Results are valid 10 minutes after sample and buffer are combined in the cassette sample well.

How accurate is the COVID-19 Rapid Test?

In order to test the detection sensitivity, specificity, and accuracy 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.

The tests resulted in a sensitivity of 88.66%, and Specificity of 90.63%, and an Accuracy of 93.41%

What do the results tell me?

A total of three detection lines are possible, with the control (C) line appearing when sample has been 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.

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