Bioneer’s Combination Tests for SARS-CoV-2 and Influenza Receive CE-IVD Marking

Bioneer (Daejeon, Korea) has received CE-IVD marking for two combination tests for SARS-CoV-2 and influenza - the AccuPower RV1 Real-Time RT-PCR Kit and AccuPower RV1 Multiplex Kit.

The AccuPower RV1 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 and Influenza infections. The 5-in-1 multiplex kit is able to detect five COVID-19 targets (E gene, RdRp & N gene) and Influenza A/B in a tube using samples collected via a nasopharyngeal swab or oropharyngeal swab taken from suspected infected patients. The easy-to-use multiplex kit reduces hands-on steps due to five-target multiplex detection in a tube. The user-convenient premix type kit enables pipetting free diagnosis since all the components for the assay are contained within a tube. It uses Bioneer’s proprietary Dual-HotStart technology to achieve high sensitivity and specificity, and the vacuum-dried premix allows for stable and reproducible results. The test kit is compatible with the ExiStation and ExiStation 48 systems.

The AccuPower RV1 Multiplex Kit is an in vitro diagnostic kit that helps diagnose COVID-19 and Influenza infections. The kit is able to detect five COVID-19 targets (E gene, RdRp & N gene) and Influenza A/B in a tube using samples collected via a nasopharyngeal swab or oropharyngeal swab taken from suspected infected patients. The easy-to-use multiplex kit reduces hands-on steps due to five-target multiplex detection in a tube and uses Bioneer’s proprietary Dual-HotStart technology to achieve high sensitivity and specificity. The test kit is compatible with various systems, including Exicycler 96 (BIONEER), CFX 96 (Bio-rad), ABI7500 Fast (Thermofisher), and Quantstudio 5 (Thermofisher).