I understand that testing will be done by appointment only.
I understand that the Pharmacist will screen each patient to determine testing needs and retains the right to refer patient to another testing facility or healthcare provider.
As it pertains to antibdoy testing: In compliance with the US FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency dated March 16, 2020 that describes the regulations for the development and US distribution of serology tests for the detection of antibodies to SARS-CoV-2, any test reports resulting from the use of the HEALGEN Profile 2019-nCoV IgG/IgM Test Card for whole blood, serum, or plasma must bear the following information:
• 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.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV2 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.