NEW YORK – An assay from CerTest BioTec to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19, has been granted CE mark.
The test, called the ViaSure SARS-CoV-2 Real Time PCR Detection Kit, uses Zaragosa, Spain-based CerTest's assay technology to amplify a portion of the virus' S gene, with all the components for testing provided in a lyophilized format. The test is adapted for Becton Dickinson's fully-automated BD Max system, which performs nucleic acid extraction and real-time PCR, and provides results for up to 24 samples in less than three hours.
"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.
Nikos Pavlidis, vice president of molecular diagnostics and women's health and cancer for BD, said that together with CerTest, the firms can now offer 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," Pavlidis said.