Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit FREND™ Antibody Test COVID-19 Total Ab For use with the FREND™ System 20 Tests 35 µL Sample VolumeFRCOD-020
Picture of Reagent Kit FREND™ Antibody Test COVID-19 Total Ab For use with the FREND™ System 20 Tests 35 µL Sample VolumeFRCOD-020

Reagent Kit FREND™ Antibody Test COVID-19 Total Ab For use with the FREND™ System 20 Tests 35 µL Sample VolumeFRCOD-020

Reagent-Kit-FREND™-Antibody-Test-COVID-19-Total-Ab-For-use-with-the-FREND™-System-20-Tests-35-µL-Sample-VolumeFRCOD-020

SKU #

#1180219

MPN #

FRCOD-020

Brand

NanoEnTek USA Inc

Stock

In Stock

Quantity

100

Features

CARTRIDGE, FREND SYS COVID-19 TOTAL ANTIBODY (20/KT) D/S

$262.23 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1180219
Manufacturer # FRCOD-020
Brand FREND™
Manufacturer NanoEnTek USA Inc
Application Reagent Kit
Container Type Cartridge
For Use With For use with the FREND™ System
Number of Tests 20 Tests
Sample Type Human Plasma Sample
Test Name COVID-19 Total Ab
Test Type Antibody Test
Time To Results 3 Minute Results
Type Fluorescene Immunoassay (FIA)
UNSPSC Code 41116126
Volume 35 µL Sample Volume
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  • 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