EU gives CE mark approval for UltraGene Combo2Screen SARS-CoV-2 assay as a diagnostic for COVID-19.- Advanced Biological Laboratories

Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen. The real-time RT-PCR test aids the diagnosis of coronavirus disease (Covid-19) infection.

Targeting the N gene + E gene regions of the SARS-CoV-2 genome (in full compliance with the WHO Guidelines) in a multiplex format with internal control for the reverse transcription and PCR steps, the UltraGene® Combo2Screen CE-IVD assay is a fast and easy-to-use diagnostic solution with the highest TCID50 sensitivity (1*10-6 TCID50/mL). The specimen is intended to be collected from nasopharyngeal swab. It is compatible with most automatic or manual RNA extraction methods, as well as with most qPCR instruments equipped with at least three channels.

Also the UltraGene Combo2Screen SARS-CoV-2 Assay is only for use in the US under the Food and Drug Administration’s Emergency Use Authorization.