Molecular Reagent FTD™ SARS-CoV-2 For Real-Time PCR Systems 96 Reactions

Features

• The use of the FTD SARS-CoV-2 as an in vitro diagnostic under the FDA Emergency Use Authorization (EUA) is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Positive results are indicative of the presence of the SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine the patient infection status
• Positive results do not rule out bacterial infection or co- infection with other viruses
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
• Negative results must be combined with clinical observations, patient history, and epidemiological information
• FTD SARS-CoV-2 is intended for use by trained qualified laboratory personnel specifically instructed and trained in the techniques of RNA extractions and real-time PCR (in vitro diagnostic procedures)
• The kit has been validated with the Applied Biosystems® 7500 Real-Time PCR System (ThermoFisher Scientific) and the NucliSENS® easyMAG® (bioMérieux)

More Information

• FTD SARS-CoV-2 FDA EUA
• FTD SARS-CoV-2 IFU
• FTD SARS-CoV-2 Healthcare Providers Fact Sheet
• FTD SARS-CoV-2 Recipients Fact Sheet