FRENOVO COVID-19 Neutralizing Antibody Rapid Test is a lateral flow immunoassay intended for the qualitative of neutralizing antibodies (NAbs) to COVID-19 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE2 cell surface receptor in human serum, plasma, fingerstick whole blood or venous whole blood specimens.
The test is intended use as an aid in identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection. FRENOVO COVID-19 Neutralizing Antibody Rapid Test should not be used to diagnose acute COVID-19 infection. Results are for the detection of total neutralizing antibodies to COVID-19.
Antibodies to COVID-19 are generally detectable in blood several days after initial infection, although the duration of time neutralizing antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute COVID-19 infection. If acute infection is suspected, direct testing for COVID-19 is necessary. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
There are 3 main uses for neutralising antibody tests:
Monitor or detect prior COVID-19 infection
Confirm if someone has produced an immune response following infection
Monitor antibody vaccine response