Antibody Test Control Set NanoEnTek COVID-19 Total Ab Positive Level / Negative Level

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 COVID-19 total Ab Control LQ should only be used with the FREND™ System
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• 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
• COVID-19 total Ab Control LQ is not intended for use as a standard
• Includes: 6 Vials of Negative control in inactivated human serum
• Includes: 6 Vials of Positive control (negative control spiked with COVID19 antibodies)

More Information

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