NEW YORK – Advanced Biological Laboratories announced Thursday its UltraGene Combo2Screen SARS-CoV-2 test received CE-IVD marking.
The real-time RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome and requires a nasopharyngeal swab specimen. The assay is compatible with "most automatic or manual RNA extraction methods," along with qPCR instruments with at least three channels, the Luxembourg-based company said. Its turnaround time is less than two hours.