Immunoassay Reagent Frend™ COVID-19 Total Ab SARS-CoV-2 Total For FREND System 20 Tests

Features

• The FREND™ COVID-19 total Ab assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• 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

More Information

• FREND COVID-19 Total Ab FDA EUA Letter
• FREND COVID-19 Total Ab IFU
• FREND COVID-19 Total Ab Healthcare Providers Fact Sheet
• FREND COVID-19 Total Ab Recipients Fact Sheet
• FREND COVID-19 Total Ab Brochure