COVID-19 Antibody Rapid Test Kit

The Real-Time RT-PCR (nucleic acid test) for SARS-CoV-2 is based on the detection of viral RNA, and it is the gold standard for COVID-19 diagnosis. The results for this nucleic acid test might take up to 3.5 hours, and the increased complexity of viral RNA extractions and PCR reaction setups require highly trained laboratory personnel. The COVID-19 IgM/IgG antibody rapid test is a qualitative test for COVID-19 IgM and IgG antibodies. It is less complex and can provide results in less than 15 minutes. However, it should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

As per FDA’s guidance on March 16th, 2020, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

• COVID-19 rapid test kits have not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Following-up with molecular diagnostic testing should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

No, the IgM/IgG rapid test does not require any other equipment. Aurora’s COVID-19 Antibody IgM/IgG Rapid Test Kit provides all the tools you need from sample collection to result reading.

Please refer to the product manual included with the test.

Yes, each test is packed separately in the box. Each test includes a COVID-19 IgM/IgG Rapid Test cassette, disposable pipet, and sample dilution buffer. Each box contains one copy of the product manual.

The minimum order is one box for either of these COVID-19 Antibody Rapid Test. This would be for 25 tests for the non-point of care test, and 20 tests for the point of care, CLIA waived test.