The Viasure SARS-CoV-2 real-time PCR detection kit from CerTest Biotec, Zaragoza, Spain, has been adapted for performance on the BD Max system from Becton, Dickinson and Company, Franklin Lakes, NJ, and has been CE marked to the European Union’s in vitro diagnostics directive (98/79/CE). The molecular test for detection of COVID-19 is available to clinical laboratories in countries recognizing the CE mark.
“The CerTest-developed kit will bring rapid COVID-19 diagnostic capabilities to many laboratories across Europe, which desperately need the ability to quickly identify COVID-19 patients so that proper protocols for infection prevention can be instituted,” says Nelson Fernandes, managing director of CerTest BioTec.
The test is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay for use on the fully automated BD Max system. It detects SARS-CoV-2 in clinical samples by amplification of a fragment of the S gene of the virus. RNA is extracted, amplified using RT-PCR, and detected using fluorescent reporter dye probes specific to SARS-CoV-2. The Via-sure kit contains in each well all the components necessary for real-time PCR assay in a stabilized format, as well as an internal control to monitor PCR inhibition.
To read more, visit Becton, Dickinson and Company.
