Bruker is launching a second-generation assay in Europe for the detection of the SARS-CoV-2 virus, which causes the respiratory and systemic disease COVID-19.
The Billerica, MA-based company said the FluoroType SARS-CoV-2 plus next-generation 6-plex PCR 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 includes all necessary reagents to produce up to 96 results in under two hours. It is validated for use on Bruker´s GenoXtract (GXT) automated nucleic acid extraction devices with associated extraction kits.
“With the FluoroType SARS-CoV-2 plus assay we expand our portfolio by an assay with added value by detecting two gene targets,” Dr. Wolfgang Pusch, Executive VP Microbiology & Diagnostics at Bruker Daltonics said in a release. “Additionally, the differentiation from other human coronaviruses, which for example can cause a common cold, reduces the risk of false-positive results due to potential cross-reactivity. We expect that these analytical features enable a very robust second-generation PCR assay with the highest sensitivity and specificity.”
Bruker said in a pilot phase and in collaboration with several partners, it has recently also begun 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.