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