IMPORTANT FACTS

• 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.

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