The SureFast® SARS-CoV-2 PLUS is a real-time RT-PCR for the direct, qualitative detection of novel coronavirus (SARS-CoV-2) RNA.
Each reaction contains an Internal Control RNA (ICR, consisting of MS2-bacteriophage) as an internal control of sample preparation procedure and to monitor possible PCR-inhibition.
Do not use for in-vitro diagnostics. Also not use for diagnostic procedures according to directive 98/79/EC or regulation (EU) 2017/746.
The real-time RT-PCR assay can be performed with commonly used real-time PCR instruments, equipped for detection of two fluorescence emissions at the channels FAM and VIC/HEX at the same time. The technical validation of instruments was performed on Roche LightCycler® 480 II, Qiagen Rotor-Gene Q, Applied Biosystems 7500 Fast Dx, Bio-Rad CFX96, R-Biopharm RIDA®CYCLER, Agilent AriaDx and Agilent Mx3005P.
|Comment||Do not use for in-vitro diagnostics. Also not use for diagnostic procedures according to directive 98/79/EC or regulation (EU) 2017/746.|
|Test format||100 reactions|
|Sample preparation||For RNA-preparation the use of SureFast® PREP DNA/RNA Virus (Art. No. F1051) is recommended.|
|LOD (Detection limit)||The SureFast® SARS-CoV-2 PLUS real-time RT-PCR has a limit of detection of < 25 RNA copies.|
Samples tested negative with SureFast®SARS-CoV-2 PLUS still could contain a SARS-CoV-2 contamination below the limit of detection of the assay.