ZARAGOZA, SPAIN and FRANKLIN LAKES, NJ, March 10, 2020 — CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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 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 MAXTM 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 MAXTMSystem is offered in a lyophilized format. Accordingly, the test comes in a tube that snaps into the test-specific position on the BD MAXTMExK™ 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 MAXTMSystem is sold through BD’s network and it is not available for sale in the United States. To locate an authorized BD representative or request information, visit: www.bd.com or www.certest.es