Bio-Speedy® Direct RT-qPCR SARS-CoV-2 Test Kit

 

Intended use: 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 obtains and preserves nucleic acid extract from the samples in VTM tubes.

 

Target: The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit targets the ORF1ab gene in the SARS-CoV-2 genome and is read in the FAM channel of the Real Time PCR instrument. The RNase P gene targeted as an internal control is also read in the HEX channel.

 

Operation and Duration: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit makes VTM samples ready for Real Time PCR within 5 minutes after combining them with vNAT® buffer and provides Real Time PCR result in a 55 minute protocol. 

 

Validated and compatible devices: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is validated for 10µl  and 20µl  reaction volumes on Roche LightCycler® 96, Bio-Rad CFX96 Touch™ and Qiagen Rotor-Gene® 5 Plex Real-Time PCR instruments. It is also compatible with all Real Time PCR instruments with FAM and HEX channels.

 

Sensitivity: 97.8% 

Specificity: 100%

BioSpeedy has been authorized by FDA under an EUA for use by authorized laboratories.