ViroKey SARS-CoV-2 RT-PCR Test v2.0 (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 SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes andbronchoalveolar lavage samples collected 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, that meet requirements to perform high complexity tests.

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. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is only for use under the Food and Drug Administration’s Emergency Use Authorization.

FDA-EUA: For use under an Emergency Use Authorization only.

SPECIFICATIONS

SpecificationsValues
Sample Types Nasopharyngeal and Oropharyngeal swabs
Gene Targets ORF1a and N gene
Limit of Detection ORF1a: 200 GE/mL
gene: 187 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 97.1% (85.1 - 99.5%)
Clinical Specificity 100% (89.8 - 100%)

FEATURES AND BENEFITS

Reliable Detection:

  • Sensitive and Robust
  • Specific to SARS-CoV-2 RNA with no cross-reactivity

Providing Laboratory Efficiency:

  • Samples to results in 4 hours
  • Hands-on time as short as 30 minutes
  • Automation from sample to report with automated PCR result analysis
  • Test up to 46 samples (plus 2 controls) per automated run

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

AUTOMATED WORKFLOW

PRODUCT FLYERS

ViroKey SARS-CoV-2 RT-PCR Test v2.0  RUO EN
ViroKey SARS-CoV-2 RT-PCR Test v2.0  EUA EN

 

ORDERING INFORMATION

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