Bruker Corporation (Nasdaq: BRKR), a provider of high-performance scientific instruments and high-value analytical and diagnostic solutions, declared on Monday that it has launched its FluoroType SARS-CoV-2 plus next-generation 6-plex PCR assay for highly specific detection of the SARS-CoV-2 virus, which causes the respiratory and systemic disease COVID-19.

The company said that its FluoroType SARS-CoV-2 plus assay is CE-IVD labelled according to the European IVD Directive (98/79/EC). It conducted two clinical trials which involved about ninety CV19 positive patients and over 100 CV19 negative individuals, which showed 100% sensitivity and 100% specificity.

According to Bruker, the FluoroType SARS-CoV-2 plus assay has been validated for respiratory samples (nasopharyngeal swabs and oropharyngeal swabs in viral transport medium) using commonly available laboratory real-time PCR thermocyclers. The kit can produce up to 96 results in under two hours and is validated for use on the company's GenoXtract (GXT) automated nucleic acid extraction devices with associated extraction kits. The assay can also be used with Bruker's novel, high-precision FluoroCycler XT real-time PCR system or with other real-time thermocyclers.

In addition, Bruker said it has recently collaborated with several partners, in a pilot phase, to offer CE-IVD marked serology antibody tests to detect previous COVID-19 infection in selected European countries, as well as a CE-IVD point-of-care (POC) antigen tests to screen for active CV19 infections in under two hours.