Quick SARS-CoV-2 rRT-PCR Kit


Quick SARS-CoV-2 rRT-PCR Kit

Cat # Name Size Price Quantity
R3011 Quick SARS-CoV-2 rRT-PCR Kit 100 rxns
Documents

Instructions for Use: 
FDA Emergency Use Authorization: 
Patient Fact Sheet: 
Healthcare Provider Fact Sheet: 
King Fisher Script: 
Quick SARS-CoV-2 rRT-PCR Kit

Highlights

  • High Sensitivity: Limit of Detection as low as 15 copies/reaction.
  • Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
  • Compatible with Automated and High-Throughput workflows.
Description

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 targets three different 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.

Learn More

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.


Compatibility Compatible with automated and high-throughput workflows.
Equipment Required Real-Time PCR Instruments capable of detecting HEX and Quasar® 670/Cy5 fluorophores.
Input Quality Purified RNA free of enzymatic inhibitors.
Processing Time ≤ 1.5 hours from set up to results.
Reagents Complete and ready to use master mixes.
Registration Status FDA-Emergency Use Authorization
Sample Input Material Purified RNA samples isolated from upper respiratory and lower respiratory systems.

Q1: Is the Quick SARS-CoV-2 rRT-PCR Kit an EUA authorized Kit? Can it be used for diagnostic purposes?

This test has been authorized by FDA under an EUA for use by authorized laboratories. This test is only authorized for the duration of that circumstances exist justifying the authorization of emergency use of in vitro diagnostic test for detection and/or diagnosis of COVID-19inder Section 564(b)(I) of the Act, 21 U.S.C. § 360bbb-3(b)(I), unless the authorization is terminated or revoked sooner.

Q2: Can I use Quick SARS-CoV-2 rRT-PCR Kit for the detection of pathogens other than SARS-CoV-2?

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other virus or pathogen.

Q3: I cannot interpret the results.

Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 rRT-PCR Kit protocol. If you still have problems with the result interpretation please contact our Technical Support team at (949) 679-1190 ext. 3 or e-mail us at tech@zymoresearch.com.

Q4: Amplification curves look strange.

Sometimes aberrant qPCR signal are observed. Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 rRT-PCR Kit protocol. If you still have problems with the result interpretation please contact our Technical Support team at (949) 679-1190 ext. 3 or e-mail us at tech@zymoresearch.com.

Q5: The No-Template Control show an amplification signal. What should I do?

This may indicate incorrect plate set-up or a contamination in the No-Template Control or in the CV Mix 1 and/or 2. We recommend to use a new aliquot of reagents.

Q6: The CV Positive Control doesn’t amplify. What should I do?

This may indicate incorrect plate set-up or the compromise of Quick SARS-CoV-2 reagents. We recommend to use a new aliquot of reagents.

Q7: RNase P human target (Quasar 670®) amplified after cycle 40 or didn’t amplify at all. How do I interpret the results?

If the host target didn’t amplify or shows CT values above 40, your RNA extraction and/or RT-PCR reaction may have been incorrectly performed. We suggest repeating RNA extraction and the RT-PCR reaction.

Q8: Signal for SARS-CoV-2 viral targets (HEX channel) was detected late, between cycle 35 and 45. Is this a valid signal? How do I interpret the results?

Late signal for SARS-CoV-2 viral targets may be indicative of a low viral load in your sample. We suggest repeating the RT-PCR to confirm results.


This kit is for use with DNA/RNA Shield collection devices for sample collection, and the Quick-DNA/RNA Viral MagBead Kit for sample processing under Emergency Use Authorization.

The end-to-end EUA authorized workflow consists of sample collection, sample preparation, and real-time RT-PCR analysis.

Authorized laboratories using the Quick SARS-CoV-2 rRT-PCR Kit must run the assay as outlined in the Instructions for Use. Deviations from the FDA authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to perform the Quick SARS-CoV-2 rRT-PCR Kit are not permitted.