VereRT™ COVID-19 PCR Kit
VereRT™ COVID-19 PCR Kit is a one-step Reverse Transcription Polymerase Chain Reaction (RT-PCR)-based In Vitro Diagnostic (IVD) test intended for the qualitative detection of nucleic acid belonging to SARS-CoV-2 in nasopharyngeal swab specimens.
The test results can be used as supplementary data for diagnosis. Negative result does not preclude SARS-CoV-2 infection and should not be used as a sole basis for treatment or other patient management decisions. Testing with VereRT™ COVID-19 PCR Kit is intended for use by trained laboratory professionals who are proficient in performing real-time RT-PCR assays.
The kit is approved for IVD use in Singapore.
Compatibility
• CommaXP® Virus DNA / RNA Extraction Kit
• QIAamp® Viral RNA Mini Kit
Recommended Thermal Cycler
• Applied Biosystems™ 7500 Real-Time PCR System
• Bio-Rad CFX96™ Touch Real-Time PCR System
• QuanStudio™ Real-Time PCR System
Gene Targets
• Dual Nucleocapsid (N1) + (N2) – FAM Channel
• Human RPP30 – HEX Channel
Sensitivity
• 2 viral RNA copies per test
Specificity
• No known cross-reactivity with human genome / other Coronaviruses / respiratory viruses
Turnaround Time
• Less than 1.5 hours
Clinical Relevance
• 98.9% PPV (359/363)
• 100% NPV (571/571)
