Reagent Kit Frend Antibody Test COVID-19 Total Ab For use with the FREND™ System 20 Tests 35 µL Sample Volume

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet requirements to perform moderate or high complexity tests

The FREND™ COVID-19 total Ab is a fluorescence immunoassay (FIA) using the FREND™ System intended for the qualitative detection of total antibody to SARS-CoV-2 in human dipotassium EDTA plasma

FREND™ COVID-19 total Ab is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; the FREND™ COVID-19 total Ab should not be used to diagnose acute SARSCoV-2 infection

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities

The sensitivity of FREND™ COVID-19 total Ab early after infection is unknown

Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV2 is necessary

False positive results for FREND™ COVID-19 total Ab may occur due to cross-reactivity from preexisting antibodies or other possible causes

Due to the risk of false positive results, confirmation of positive results should be considered using second, different total antibody assay

Results can be obtained in less than 3 minutes with only 35 µl of sample volume using the FREND System

Kit includes: 20 cartridges, 20 dilution tubes, 40 disposable pipette tips, code chip, and package insert

The following materials are NOT provided with the reagent but are required to perform COVID-19 total antibody analysis using the FREND™ COVID-19 total Ab on the FREND™ System: FREND™ System including calibrated pipette and QC Cartridge and QC Code chip manufactured by NanoEntek