Quick SARS-CoV-2 Multiplex Kit
R3013 / R3013-1K / R3013-10K
Quick SARS-CoV-2 Multiplex Kit
- High Sensitivity: Limit of Detection as low as 10 GEC/reaction (167 GEC/ml)
- Specific: Detection of SARS-CoV-2 and Emerging Strains
- Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
- Compatible with Automated and High-Throughput workflows.
- CE-IVD Marked
The Quick SARS-CoV-2 Multiplex 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 Multiplex Kit targets a region 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 Multiplex Kit can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.
The Quick SARS-CoV-2 Multiplex Kit has High Sensitivity, with a Limit of Detection as low as 10 viral genome equivalent copies per reaction, a fast turnaround time of less than 2 hours, and a simple workflow in which RNA is simply added to the Quick SARS-CoV-2 Multiplex Kit reagent 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 capable of detecting HEX/VIC and Quasar 670/Cy5 fluorophores and technical support is available for all steps of the setup process and data interpretation.
In the United States:
-This test has not been FDA cleared or approved and it is currently CE IVD marked.
|Compatibility||Compatible with automated and high-throughput workflows.|
|Equipment Required||Real-Time PCR Instruments capable of detecting HEX/VIC and Quasar® 670/Cy5 fluorophores. Adjustments of the RT-PCR parameters may be necessary for instruments different than the CFX96 Touch from Bio-Rad.|
|Input Quality||Purified RNA free of enzymatic inhibitors.|
|Processing Time||≤ 2 hours from set up to results.|
|Reagents||Complete and ready to use master mix.|
|Registration Status||CE-IVD Marked|
|Sample Input Material||Purified RNA from upper respiratory and lower respiratory systems.|
Q1: Is the Quick SARS-CoV-2 Multiplex Kit a diagnostic test?
This test has not ben FDA cleared or approved. In the USA this test can be adopted in clinical diagnostics laboratories as an LDT according to local state guidelines. The test can be used for RUO/Informational purposes. The test is currently pending for CE IVD certification.
Q2: Can I use Quick SARS-CoV-2 Multiplex Kit for the detection of pathogens other than SARS-CoV-2?
This test detects specifically SARS-CoV-2 and cannot be used to detect other viruses or pathogens.
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 Multiplex 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 email@example.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 Multiplex 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 firstname.lastname@example.org.
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 2X CV Mix. We recommend repeating the test, and if the problem persists to use a new aliquot of reagents.
Q6: The CV Positive Control doesn’t amplify. What should I do?
If using RT-PCR instruments different than the CFX96 Touch from Bio-Rad, this problem can be solved by adjusting the RT-PCR parameters (e.g. baseline threshold, temperature ramp, ...).
This problem may also indicate incorrect plate set up of the compromise of Quick SARS-CoV-2 reagents.
Please contact our Technical Support team at (949) 679-1190 ext. 3 or e-mail us at email@example.com
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: 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 10 GEC/reaction the Quick SARS-CoV-2 Multiplex 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.