IMPORTANT FACTS
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This test has not been reviewed by the FDA. The tests distributed are registered and listed with FDA, and conforms to FDA guidelines for COVID-19 point of care serological tests.
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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.
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Negative results DO NOT rule out SARS-CoV-2 infection, particularly those in those who have been in contact with the virus.
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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.
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Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
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For use only by clinical laboratories and healthcare workers at the point-of-care.
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Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.