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SARS-COV-2 R-GENE®
Real-time PCR kit for the detection of SARS-COV-2, the causative pathogen of COVID-19
- One all-in-one kit
- Two triplex PCR
- Results delivered in 4 to 5 hours
- Validated on major extraction and amplification platforms
- Validated in nasopharyngeal swabs, nasal swabs, oropharyngeal (throat) swabs and saliva
SARS-COV-2 R-GENE® advantages
- All-in-one kit for an efficient order management
- Two triplex PCR for reliable diagnosis
- PCR1
- SARS-COV-2 N gene (FAM) / Internal Control (HEX) / SARS-COV-2 RdRp gene (CY5)
- is performed as a first step for the detection of SARS CoV 2
- PCR2
- SARBECOVIRUS E gene (FAM) / Internal Control (HEX) / Cellular Control (CY5)
- is optional and may be performed on the same eluate to monitor sample quality by confirming the presence of human cells
- PCR1
- Internal control to check PCR processing & cellular control to check sampling for secured results
- Results delivered in 4 to 5 hours for optimized workflow and better patient management
- Laboratory workflow integration
- Validated on major extraction and amplification platforms
- For use on manual workflow or on automated workflow ARGENE® SOLUTION
Everything you need in one kit
The SARS-COV-2 R-GENE® kit is a molecular detection kit, using real-time PCR after viral nucleic acids extraction. Assay includes all necessary reagents optimized to detect SARS-COV-2 for in vitro diagnostic use:
- Ready-to use master mix (including Taq polymerase)
- Reverse transcriptase
- Positive controls
- Negative control
- An Internal Control (IC1) checks the extraction process and the presence of amplification inhibitors in the sample (in PCR1)
- A cellular control checks the sampling (in PCR2)
Easy procedure
Using SARS-COV-2 R-GENE® assay is easy. Just add the extracted RNA sample to 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”.
SARS-COV-2 R-GENE® (423720) - Real Time Detection kit | |
---|---|
Principle of the test | Genomic detection of SARS-COV-2 |
Ordering information | Reference: 423720 Designation: SARS-COV-2 R-GENE® - Real Time Detection kit |
Technology | Real-Time PCR / 5‘ nuclease technology |
Gene target | N gene (PCR 1), RdRp gene (PCR 1) and E gene (PCR 2) |
Specimen | Nasopharyngeal swabs, nasal swabs, oropharyngeal (throat) swabs and saliva |
Detection limit | LoD 95%: 0.43 TCID50/mL (equivalent to 380 copies/mL) |
Controls included | Extraction / Inhibition Control, Negative Control, Positive Controls, Cell control |
Results within | 120 minutes after extraction |
Number of tests | 120 tests (120 tests PCR1 + 30 tests PCR2) |
Storage conditions | -15°C/-31°C |
Extraction platform |
- EMAG® |
Amplification platform | - LightCycler 480 (System II) - ABI 7500 Fast, ABI 7500 Fast Dx - QuantStudio5, QuantStudio5 Dx - Rotor-Gene Q - CFX96 |
Status | For in vitro diagnostic use, CE-IVD marking |
Please consult your local bioMérieux representative for product availability in your country
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