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SARS-COV-2 R-GENE® - EUA
True to our public health mission, we rely on more than 25 years of expertise in the diagnosis of viral infections. SARS COV-2 R-GENE® is an Emergency Use Approved (EUA) real-time (RT) polymerase chain reaction (PCR) kit for the qualitative detection of the SARS-CoV-2 virus responsible for the COVID-19 infection.
SARS COV-2 R-GENE® allows performing batch analyses to test a large number of patients at a time. It can be carried out by laboratories with expertise in molecular biology on most real-time PCR systems available on the market. It provides a result in 4 to 5 hours.
- All-in-one kit for an efficient order management
- Two triplex PCR assays improve the reliability of the test in consideration of potential viral mutations that may affect diagnostic sensitivity.
- PCR1: Specific to SARS-CoV-2 N Gene (FAM) / RdRp Gene (CY5) / IC1 (HEX)
- PCR2: generic to SARBECOVIRUS(*) E Gene (FAM) / IC1 (HEX) / Control Cell
(*)Taxonomy SARS-CoV-2 coronavrus is a member of the genus Betacoronavirus (group 2) and subgenus Sarbecovirus (subgroup B).
Everything you need in one kit
- Ready-to-use amplification master mix (including Taq polymerase) positive, negative controls
- Reverse Transcriptase® III (requires dilution)
- Internal control (IC1) checks the extraction process and the presence of amplification inhibitors in the sample. (PCR1)
- Cellular control checks the presence of epithelial cells in the sample, which reflects the quality of the sampling. (PCR2)
- No known cross-reaction with CoV-229E, CoV-NL63, CoV-OC43, CoV-HKU1, SARS-CoV-1, and MERS-CoV
Laboratory workflow integration. Authorized to be used with a variety of different extraction and amplification platforms:
- bioMérieux NUCLISENS® easyMAG® with software version 2.1 and EMAG® version 1.1
- Qiagen QIASymphony SP with software version 4.1
- Roche MagNA Pure 96 with software version 3.1
Open real-time PCR systems:
- Applied Biosystems™
- 7500 Fast with software version 2.3
- 7500 Fast Dx with software version 1.4
- QuantStudio™ 5 Dx with software version 1.0
- Roche LightCycler® 480 Instrument II with software version 1.5
- Bio-Rad CFX96 with software Maestro 1.1
- Qiagen Rotor-Gene Q with software 2.3
Use manual or automated assay setup platform, such as ESTREAM®.
Features and Specifications
Using SARS-COV-2 R-GENE® is easy. Add the Internal Control (IC) to the extracted RNA sample then, add the pre-diluted Taq polymerase, the ready-to-use PCR master mix and start the reaction on the appropriate Real-Time PCR thermocycler, following optimized cycling program described in the “Instructions For Use."
Frequently Asked Questions
HAVE YOU TESTED THE KIT IN CLINICAL SAMPLES?
Yes, our ARGENE® kit has been tested on 20 clinical samples (7 positives, 13 negatives) by the French National Reference Center for Respiratory Virus.
DO I NEED TO USE BOTH PCR OR CAN I PROCESS PCR 1 ONLY?
- Our recommendation is to use PCR 1 (120 tests) SARS-COV-2 specific triplex PCR as the front-line PCR.
- PCR 2 (30 tests) SARBECOVIRUS generic triplex PCR may be used as the second-line PCR.
- In case of equivocal PCR 1 result (i.e. 1 out 2 genes of PCR1 is NEG)
- In case of doubt of efficient sampling to evaluate the presence of human epithelial cells
WHY DON'T YOU TARGET THE ORF1b GENE?
We have selected the 2 genes for SARS-COV-2 specific PCR that demonstrated the best analytical performances (specificity and sensitivity) with the ARGENE master mix:
- N gene coding for nucleoprotein
- RdRp gene coding for RNA dependent RNA polymerase (located in ORF1ab)
DO WE HAVE TO EVALUATE THE SAMPLE QUALITY?
Not routinely necessary, but could be used if the sample quality is in doubt.
IF ONLY THE RESULTS FOR PCR 2 ARE POSITIVE, WILL THE TEST BE REPORTED AS NEGATIVE?
No, it will be reported as Positive for Sarbecovirus (means it can be SARS-COV-2 or SARS-COV-1).
WHAT ARE THE LIMITATIONS OF THE TEST?
The use of this assay as an in vitro diagnostic under the FDA Emergency Use Authorization (EUA) is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.
The use of this assay is limited to personnel who are trained in the procedure. Failure to follow these instructions may result in erroneous results.
Extraction and amplification of nucleic acid from clinical samples must be performed according to the specified methods listed in this procedure. Other extraction approaches and processing systems have not been evaluated.
The performance of the SARS-COV-2 R-GENE® assay was established using contrived nasopharyngeal swab samples. Oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes and bronchoalveolar lavage (BAL) fluid are also considered acceptable specimen types for use with the SARS-COV-2 R-GENE assay. Please refer to the FDA FAQs on Diagnostic Testing for SARS-CoV-2 for additional information regarding acceptable specimen types for detection of SARS-CoV-2.
Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient management decision. A positive result indicates the detection of nucleic acid from the relevant virus. The nucleic acid may persist even after the virus is no longer viable. Laboratories are required to report all positive results to the appropriate public health authorities.
DATE OF EUA ISSUANCE
FACT SHEETS & LABELING
EUA DETERMINATION AND DECLARATION
May 6, 2020