MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

More Tests on the Way as Coronavirus Spreads

Both CerTest Biotec and Becton Dickinson and Company have received a CE mark for the VIASURE SARS-CoV-2 Real-Time Polymerase Chain Reaction (PCR) Detection Kit adapted for the BD Max System.

As the coronavirus continues to spread, companies are ramping up efforts to develop diagnostics. The latest diagnostic comes from CerTest Biotec and Franklin Lakes, NJ-based Becton Dickinson and Company (BD). The duo announced Tuesday the VIASURE SARS-CoV-2 Real-Time Polymerase Chain Reaction (PCR) Detection Kit had been adapted for the BD Max System and won CE mark for use in Europe.

In a release, the companies said the VIASURE SARS-CoV-2 Real-Time PCR Detection Kit is a real-time reverse transcriptase 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, according to the release.

“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,” Nelson Fernandes, managing director of CerTest BioTec, said in a release.

Zaragoza, Spain-based, CerTest Biotec and BD’s offering comes on the heels of several announcements in recent weeks on the availability of diagnostics aimed at detecting the coronavirus.

Qiagen, which is in the process of being acquired by Thermo Fisher Scientific for $11.5 billion, announced in late February it had shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China. The Venlo, Netherlands-based company said it also sent the test kit to public health institutions in other regions, including Europe, South-East Asia, and the Middle East.

Last week, Quest Diagnostics said it was launching its COVID-19 test service in the U.S. that aids in the presumptive detection of nucleic acid in respiratory specimens. Laboratory Corporation of America Holdings (LabCorp) announced the availability of its 2019 Novel Coronavirus (COVID-19), NAA test. The Burlington, NC-based company said the test can only be ordered by physicians and other authorized healthcare providers anywhere in the U.S.

Salt Lake City, UT-based Co-Diagnostics has been in the spotlight since the eruption of the coronavirus and received CE mark for the Logix Smart COVID-19 Test in late February.

 

Filed Under
500 characters remaining