COVID 19 IgG/IgM antibody

PHYSICIAN REVIEW: This test is ordered by our inhouse physician (not PWNHealth). If you have questions about the reuslts, you can call us at 1-877-511-5227 to make arrangement to speak with our inhouse physician for an additional $50.

The ImmunoLabs COVID 19 IgG/IgM antibody test may be used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in the blood. This test can be collected in the comfort of your own home and the specimen shipped back to the laboratory for testing. This test is not a diagnostic test. This test looks for antibodies in the blood that your body produced in response to an infection. These antibodies are IgM and IgG. Antibodies may take up to 2 weeks after exposure to a virus to be detected

Negative results: This means IgM or IgG antibodies were not detected in the specimen you provided. The results suggest that you were not exposed to SARS-CoV-2, or have not developed the  antibodies. If you were recently diagnosed with COVID-19, were exposed to someone with COVID-19, or previously had symptoms of COVID-19, there is a possibility of a false negative. If you test too soon, your body may not have produced enough antibodies to be detected by the test yet. If that is the case, retesting may be needed.

IgM Positive results: These are the first antibodies the body develops when a new pathogen, such as the novel coronavirus, is introduced to the body. This may indicate an early infection and symptoms may or may not be present.

IgM and IgG positive results: Both antibodies may be detected in the body within 1 to 2 weeks of exposure.

IgG positive results: This means that IgG antibodies were detected in the specimen you provided. 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. 

• The test results may help to identify immunity to the virus, providing valuable insight to anyone who wants to understand their risk of becoming ill or transmitting the virus to others.This test performance has been validated by Immuno Laboratories according to high-complexity testing under Clinical Laboratory Improvement Amendments (CLIA). The FDA has made these tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).

Is this test FDA-approved?

At the moment there are more than 300 test kits being reviewed by the FDA, and the FDA has issued Emergency Use Authorization. This test has not been reviewed by the FDA.

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 a 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

  This test kit will be mailed to you via USPS. You will receive a blood collection device as well as other materials in the test kit. Please review all instructions prior to performing this test. Kits should be shipped via FedEx back to the laboratory in the enclosed packaging. Results take 1 to 3 days upon receipt of the specimen by the laboratory.

  TEST COLLECTION INSTRUCTIONS PDF

Reviewed By: Dr. Kurt Kloss, MD
Last Reviewed Date: Jun 17, 2020