ViroKey SARS-CoV-2 RT-PCR Test v1.0 (EUA)
Specific Detection of SARS-CoV-2 RNA for COVID-19
The ViroKey SARS-CoV-2 RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
The ViroKey SARS-CoV-2 RT-PCR Test comprises of a ready-to-use system for the detection of SARS-CoV-2 RNA by Reverse Transcription PCR (RT-PCR) on the Applied Biosystems® 7500 Fast Dx Real-Time PCR System or the Sentosa SA201 Real-Time PCR Instrument, with manual nucleic acid extraction and Reverse Transcription PCR assay set-up.
Positive results are indicative of active infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
EUA: For use under an Emergency Use Authorization (EUA) only.
| Specifications | Values |
|---|---|
| Sample Types | Nasopharyngeal and Oropharyngeal swabs |
| Gene Targets | ORF1a and RdRp |
| Limit of Detection | ORF1a: 250 GE/mL RdRp: 560 GE/mL |
| Analytical Reactivity | 100% match to 25,212 and 2,531 complete SARS-CoV-2 sequences on GISAID and NCBI databases, respectively |
| Analytical Specificity | No cross-reactivity with 24 pathogen species |
| Clinical Sensitivity | 97.2% (85.8 - 99.5%) |
| Clinical Specificity | 95.1% (88.1 - 98.1%) |
Supporting Clinical Diagnosis:
- Sensitive and Robust
- Specific to SARS-CoV-2 RNA with no cross-reactivity
- High-throughput RT-PCR
- Allows for flexible sample processing
- Able to detect both SARS-CoV-2 B.1.1.7 and 501.V2 strains
Providing Laboratory Efficiency:
- Samples to results in 3.5 hours
- Only 230 μL of sample input needed
- Easy adoption by laboratories with existing PCR instruments
PRODUCT FLYERS
| Product | Pack Size | Item Number |
|---|---|---|
| Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) RUO | 4x24 | 300044 |
| Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) US-IVD | 4x24 | 300353 |
| ViroKey SARS-CoV-2 RT-PCR Test (4x48) EUA | 4x48 | 300681 |
| ViroKey SARS-CoV-2 RT-PCR Test (4x48) RUO | 4x48 | 300682 |
| ViroKey SX Virus Total Nucleic Acid Kit (4x48) RUO | 4x48 | 300679 |
ViroKey SARS-CoV-2 RT-PCR Test v1.0 Information Page
