ViroKey SARS-CoV-2 RT-PCR Test v1.0 (Pre-EUA)

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

DESCRIPTION

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.

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 RdRp
Limit of Detection 50 copies/reaction
Analytical Reactivity 100% match to 105 sequences in NCBI SARS-CoV-2 database
Analytical Specificity No cross-reactivity with 18 pathogen species
Clinical Sensitivity 100% (88.6 - 100%)
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
  • Allows for flexible sample processing

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

MANUAL WORKFLOW

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (IVD) 4x24 300353
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (RUO) 4x24 300044
ViroKey SARS-CoV-2 RT-PCR Test (Pre-EUA) 4x48 300681
ViroKey SARS-CoV-2 RT-PCR Test (RUO) 4x48 300682
ViroKey SX Virus Total Nucleic Acid Kit (RUO) 4x48 300679