The Quick SARS-CoV-2 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test for the qualitative detection of RNA from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is responsible for the coronavirus disease (COVID-19).
The Quick SARS-CoV-2 rRT-PCR Kit detects N1, N2, and N3 regions of the viral nucleocapsid (N) gene and a host-specific target region (human RNase P gene) to assess sample quality. The kit also includes CV Positive Control that enable assay performance monitoring, and a No-Template Control to confirm the absence of contamination in the reagents.
The Quick SARS-CoV-2 rRT-PCR Kit can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.
The Quick SARS-CoV-2 rRT-PCR Kit has High Sensitivity, with a Limit of Detection as low as 15 viral genome equivalent copies per reaction, a fast turnaround time of less than 1.5 hours, and a simple workflow in which RNA is simply added to the Quick SARS-CoV-2 rRT-PCR Kit reagents and directly analyzed.
Due to its simplicity, set-up up can be performed in an automation and it is compatible with high-throughput platforms. The kit is compatible with multiple Real-Time PCR instruments and technical support is available for all steps of the setup process and data interpretation.
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In the United States:
-This test has not been FDA cleared or approved;
-This test has been authorized by FDA under an EUA for use by authrized laboratories;
-This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
-This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner
Qualitative assay for use on the Bio-Rad CFX96 Real-Time PCR Detection System. For use under the FDA Emergency Use Authorization (EUA) only. For in vitro diagnostic use.
