CerTest Biotec and BD have announced that the VIASURE SARS-CoV-2 Real-Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/CE). The molecular test for the 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," said Nelson Fernandes, managing director of CerTest BioTec.

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.

"Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics. Leveraging the significant install-base of the BD MAX System in Europe and other countries, we hope this kit will greatly enhance capacity for COVID-19 testing, thereby helping clinicians rapidly diagnose patients and ultimately prevent the spread of COVID-19," said Nikos Pavlidis, vice president of molecular diagnostics and women's health and cancer for 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. 

For more information go to: moleculardiagnostics.bd.com/bd-max-system/open-system-reagents/