ViroKey SARS-CoV-2 RT-PCR Test v2.0 (EUA)
Specific Detection of SARS-CoV-2 RNA for COVID-19
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage samples collected from individuals suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. 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.
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, that meet requirements to perform high complexity tests. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The following indication is authorized under the FDA’s Pooling and Serial Testing [Amendment Letter] for use in laboratories certified under CLIA to perform high complexity tests. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 test is intended for the qualitative detection of RNA from the SARS-CoV-2 in pooled samples containing aliquots of transport media from up to 3 individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals without symptoms or other reasons to suspect COVID-19, and placed in individual vials containing transport media when tested at least once per week as part of a serial testing program.
Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive or invalid result must be reported as presumptive positive or tested individually prior to reporting a result.
FDA-EUA: For use under an Emergency Use Authorization only.
| Specifications | Sentosa® SX101 Only | Sentosa® SX101 & KingFisher Flex | Hamilton Microlab STAR |
| Sample Types | Nasopharyngeal and Oropharyngeal Swabs in UTM/UVT | ||
| Gene Targets | ORF1a and N gene | ||
| Limit of Detection | 200 GE/mL | 250 GE/mL | 200 GE/mL |
| Analytical Reactivity | Able to detect all 2,636,603 SARS-CoV-2 sequences on GISADI and NCBI Database | ||
| Analytical Specificity | No cross-reactivity with 25 pathogens | No cross-reactivity with 24 pathogens | |
| Hands-on Time | 40 minutes | 50 minutes | 1 hour |
| Turnaround Time | 4 hours | 3.5 hours | 4.75 hours |
| Samples per run | 46 | 94 | 376 |
| Clinical Sensitivity | 97.1% (95% CI: 85.1 - 99.5%) | 100% (95% CI: 88.6 - 100.0%) | |
| Clinical Specificity | 100.0% (95% CI: 89.8 - 100.0%) | 100% (95% CI: 88.6 - 100.0%) | |
Reliable Detection:
- Sensitive and robust
- Specific to SARS-CoV-2 with no cross-reactivity
- Able to detect B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617.2 (Delta) strains (wet lab tested)
- Also detects B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), and C.37 (Lambda) strains (in silico tested)
Providing Laboratory Efficiency:
- Sample to result solutions in as short as 4 hours
- Hands-on time as short as 30 minutes
- Automation from sample to result with automated PCR result analysis
- Three different workflows to suit varying laboratory throughput requirements
- Test up to 46/94/376 samples per automated run
- 3-in-1 pooling strategy available; detect SARS-CoV-2 from up to 3 combined samples in a single reaction
Increasing Cost Effectiveness:
- Two targets combined in one test to save reagent and consumable costs
- Comprehensive and fast result call-out to reduce patient management cost
PRODUCT FLYERS
| Product | Pack Size | Item Number |
|---|---|---|
| ViroKey HT Virus Total Nucleic Acid Kit (4x96) IVD | 4x96 | 301088 |
| ViroKey HT Virus Total Nucleic Acid Kit (4x96) RUO | 4x96 | 301090 |
| ViroKey SARS-CoV-2 High PC (96) RUO | 96 | 301098 |
| ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96) EUA | 4x96 | 301085 |
| ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96) RUO | 4x96 | 301087 |
| ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) EUA | 8x48 | 301068 |
| ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) RUO | 8x48 | 301070 |
| ViroKey SX Virus Total Nucleic Acid Kit (4x48) RUO | 4x48 | 300679 |
| ViroKey SX Virus Total Nucleic Acid Kit (4x48) US-IVD | 4x48 | 300677 |
FACTSHEETS
| ViroKey SARS-CoV-2 RT-PCR Test Patients Factsheet | EUA | EN |
| ViroKey SARS-CoV-2 RT-PCR Test Healthcare Providers Factsheet | EUA | EN |
