Bio-speedy® Direct SARS-CoV-2 RT-qPCR Kit Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is a real-time and one-step reverse transcription PCR test used for the qualitative detection of the SARS-CoV-2 specific ORF1ab gene. The vNAT® buffer included in the kit enables the nucleic acid extract to be obtained and preserved from the samples in VTM tubes. The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit makes the samples in the VTM ready for Real Time PCR 5 minutes after they are combined with vNAT® buffer and provides the Real Time PCR result in a 55 minute protocol. Sensitivity: 97.8% Specificity: 100% Limit of Detection: 200 copies/mL (For all sample types) Certification: CE-IVD, FDA EUA Certified Effect of Sars-CoV-2 Variants: No effect Result Time: 55 minutes