These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29, 2020 to Healgen Scientific, LLC, the U.S. subsidiary of manufacturer Zhejiang Orient Gene Biotech, Limited.

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative test for the detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in whole blood, plasma (Li+-heparin, K2-EDTA and sodium citrate), and serum. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organization’s emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:

  • This test has 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. Follow-up testing with a molecular diagnostic 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.

An easy-to-use test kit that provides results in just 10 minutes, Healgen OrientGene COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within 3-5 days following incubation and IgG that appears as soon as 1-2 weeks. The tests are authorized for prescription use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.

If you are a medical professional or supply medical professionals or medical facilities, please click here to learn more about our Healgen OrientGene COVID-19 IgG/IgM Rapid Test kits. For additional information on coronavirus testing and resources, please visit Amplicon.

We look forward to serving the medical professionals in need of serology testing. We are proud to be playing a role to help in the COVID-19 health crisis.