The US-based labs that RHM contracts with are certified under the Clinical Laboratory Improvements Amendment of 1988 (CLIA ’88), accredited by the College of American Pathologists (CAP), and has over 5 years’ experience designing, validating, and performing Laboratory Developed Tests (LDTs) for physicians and patients. Maintaining accreditation through the CAP requires that LDTs are validated to standards exceeding those listed in CLIA ’88 which defines the minimum standards that must be met in order to perform LDTs for diagnostic purposes.

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. 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. Not for the screening of donated blood.