If you are coming in for a rapid Antibody Test to detect Coronavirus infection, also known as Covid 19 or SARS-Cov-2, please read the following statement.
The Standard Q COVID-19 IgG/IgM Rapid Test is being marketed in accordance with the U.S. Food and Drug Administration’s (FDA’s) recent guidance, titled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” which was issued on March 16, 2020. FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.
• 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. Negative test results should be viewed cautiously, especially for individuals in higher-risk groups like healthcare workers.
• 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, or past or present infection with SARS virus (no. 6). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
• Not for screening of donated blood.