ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Pre-EUA)

Specific Detection of SARS-CoV-2 RNA for COVID-19

DESCRIPTION

The 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 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 v2.0 is configured for use on the Sentosa SX 101 instrument, with the ViroKey SX Virus Total Nucleic Acid Kit, in conjunction with Sentosa SA201 or Applied Biosystems 7500 Fast Real-Time PCR system.

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.

Pre-EUA: Distributed in accordance with Section IV.C.2 (FDA Notifications) of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, dated May 11, 2020.

SPECIFICATIONS

SpecificationsValues
Sample Types Nasopharyngeal and Oropharyngeal swabs
Gene Targets ORF1a and N gene
Limit of Detection 200 GE/mL
Analytical Reactivity 100% match to >99% of SARS-CoV-2 sequences (46,636*) on GISAID and NCBI databases, with at most 1 mismatch for the remaining sequences
*As of 18 June, 2020
Analytical Specificity No cross-reactivity with 25 pathogens tested
Clinical Sensitivity 96.7% (83.3 - 99.4%)
Clinical Specificity 100% (88.6 - 100%)

FEATURES AND BENEFITS

Supporting Clinical Diagnosis:

  • Sensitive and Robust
  • Specific to SARS-CoV-2 RNA with no cross-reactivity
  • High-throughput RT-PCR

Providing Laboratory Efficiency:

  • Samples to results in 4 hours
  • Only 230 μL of sample input needed
  • Two targets combined in one test to save reagent and consumable costs
  • Comprehensive and fast result call-out to reduce patient management cost

AUTOMATED WORKFLOW

ORDERING INFORMATION

ProductPack SizeItem Number
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Pre-EUA) 8x48 301068
ViroKey SX Virus Total Nucleic Acid Kit (IVD) 4x48 300677
ViroKey SX Virus Total Nucleic Acid Kit (RUO) 4x48 300679