OpGen has announced its subsidiary Curetis GmbH has obtained CE certification for its SARS-CoV-2 kit which comes with a PCR-Compatible Universal Buffer (PULB). OpGen claims the test demonstrated 100% sensitivity and 97.3% specificity.

Developed and manufactured by Curetis’ team in Germany, the SARS-CoV-2 Kit with PULB uses real-time reverse transcription-polymerase chain reaction (RT-PCR) technology for the qualitative detection of the SARS-CoV-2.

This kit can be used with RNA isolated by performing standard RNA isolation processes, as well as with oropharyngeal or nasopharyngeal swabs collected in PCR compatible viral transport medium treated with PULB provided in the Kit.

Including PULB in the kit as a workflow option allows labs to circumvent the need for extraction equipment and extraction kits/reagents, thereby providing operational and workflow efficiencies, time and cost savings.

The kit is designed to provide time to results in approximately one hour, and it runs on open real-time PCR instruments such as the QuantStudio™ 5 Real-Time PCR System and the Bio-Rad CFX96™ Real-Time PCR Detection System.

“Having access to our SARS-CoV-2 kit allows us to have that product distributed rather than the BGI test kit which we will cease distributing effective immediately,” said Oliver Schacht, PhD, CEO of OpGen.