On Mar. 10, 2020, BCerTest Biotec, along with BD (Becton, Dickinson and Company) announced that the VIASURE SARS-CoV-2 Real Time PCR Detection Kit adapted for the BD MAX System had been CE marked to the IVD Directive. The molecular test for detection of COVID-19 was available to clinical laboratories in countries recognizing the CE mark.

The test is a real-time reverse transcriptase polymerase chain reaction (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. This VIASURE 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.

As with all CerTest tests, the VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX™ System is offered in a lyophilized format. Accordingly, the test comes in a tube that snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, which is supplied by BD.

The BD MAX™ System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours.

VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX™ System is sold through BD’s network and it is not available for sale in the United States.