IEH SARS-CoV-2 RT-PCR Kit is a highly sensitive real-time RT-PCR kit to enable clinical laboratories to rapidly diagnose SARS-CoV-2 infections. It is based on the primer/probe sets described in the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel, developed by US CDC which includes N1 and N2 primer/probe sets that detects viral nucleocapsid RNA.
For prescription use only. For in vitro diagnostic use. Testing is limited to those certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
This kit has been validated for both Kingfisher (ThermoFisher) based automated RNA extraction as well as spin column based extraction. With the Kingfisher system, 44 specimens can be analyzed to completion within 4 hours. Validated RT-PCR thermocyclers include Agilent/Stratagene 3005P and Biorad CFX96.
This in vitro diagnostic test is pending FDA review under the EUA program.