Running a Test 

Testing can be completed in 15 minutes. A blood specimen is required.    

Step 1 Use lancet device to obtain a drop of blood. Collect blood using a transfer pipette (provided).  

Step 2. Drop 1 drop (10 ul) of blood onto test strip  

Step 3. Add 2 drops of buffer solution into well.   

Step 4 Wait approximately the amount of time indicated in the Instructions For Use after which a positive control indicator line is visible.

HOW IT WORKS   

The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-CoV-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device.  The following graph is for illustration purposes only. Significant differences in the post-infection incubation period required for seroconversion are believed to exist.

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-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.It is not known whether persons having antibodies to SARS-CoV-2 are not infectious, can be re-infected or may experience COVID-19 in the future.