This person receiving the test is the person who needs to fill out and sign this form.

You have requested that we test your blood to see if you have COVID-19 antibodies. We will use a serologic test, the “CoronaChek COVID-19 IgG/IgM Rapid Test Cassette,” which we have purchased from CLIAwaived, Inc., in San Diego, CA.

• We will obtain your blood for the test from a finger stick
• We should have the results for you in about 15 minutes after the test starts.

This is not a test to detect an active COVID-19 infection. IT IS A TEST TO LOOK FOR PROTECTIVE ANTIBODIES AGAINST THE VIRUS.

We have read a peer-reviewed, published article, “Development and Clinical Application of a Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis” by Zhengtu Li, et al., developers of the test, cited as doi:10.1002/jmv.25727.
That study collected blood samples from 397 confirmed COVID-19 patients and 128 negative patients at 8 clinical sites in China. Results: the overall testing sensitivity was 88.66% and specificity was 90.63%.
We make the following additional disclosures to you and request that you read and sign the acknowledgment below.

• This test has not been approved 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. We do not perform such a molecular diagnostic. Consult your physician.
• Results from this 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.