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Quick SARS-CoV-2 rRT-PCR Kit

Highlights
Approved for emergency use authorization (EUA) by the U.S. Food and Drug Administration and CE-IVD certified.
High Sensitivity: Ranked among the top three most sensitive EUA tests by the FDA, with a Limit of Detection as low as 250 GEC/ml (15 GEC/reaction).
Specific: Detection of SARS-CoV-2 and Emerging Strains (including Omicron)
Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
Compatible with Automated and High-Throughput workflows.

서한형 대리

Zymo Research 제품 담당자

경신과학(주)

영업부

H.P) 010-8832-6303

HanHyung Seo

Zymo Research Brand Manager

Kyongshin scientific Co., Ltd.

Sales Department

H.P) 82)10-8832-6303

제품소개

Highlights

Approved for emergency use authorization (EUA) by the U.S. Food and Drug Administration and CE-IVD certified.
High Sensitivity: Ranked among the top three most sensitive EUA tests by the FDA, with a Limit of Detection as low as 250 GEC/ml (15 GEC/reaction).
Specific: Detection of SARS-CoV-2 and Emerging Strains (including Omicron)
Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
Compatible with Automated and High-Throughput workflows.

Documents

Instructions for Use:

Patient Fact Sheet:

Healthcare Provider Fact Sheet:

KingFisher™ Script:

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 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.
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.

Technical Specifications

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
CE-IVD certified
Sample Input Material Purified RNA samples isolated from upper respiratory and lower respiratory systems.

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 CE-IVD certified
Sample Input Material	Purified RNA samples isolated from upper respiratory and lower respiratory systems.

FAQ

Q1: Is the Quick SARS-CoV-2 rRT-PCR Kit a diagnostic test?

This test has been authorized by the U.S. FDA under an EUA and CE-IVD certified for use by authorized laboratories. In the U.S. 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-19 under 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.

Q9: Why SARS-CoV-2 and human Rnase P targets are detected in two separate RT-PCR reactions?

Viral and human targets are amplified in two separate reactions in order to prevent potential competition between PCR. Detecting viral and human targets in two separate reaction minimizes false negative results even in samples with extremely low viral titer.

Q10: How the Quick SARS-CoV-2 rRT-PCR Kit performs compared to other FDA EUA and CE-IVD molecular tests?

With a limit of detection(LoD) as low as 15 GEC/reaction the Quick SARS-CoV-2 rRT-PCR Kit outperforms most of the SARS-CoV-2 molecular tests present on the market.
In addition, the detection of a host target (human Rnase P) allow the identification of insufficient samples, which other tests may classify as negative; this further reduce the chances of the false negative results.

주문정보

CAT.No	품명	규격
R3011	Quick SARS-CoV-2 rRT-PCR Kit	100 rxns
R3011-1K	Quick SARS-CoV-2 rRT-PCR Kit	1,000 rxns
R3011-10K	Quick SARS-CoV-2 rRT-PCR Kit	10,000 rxns