CE marked FlexStar® SARS-CoV-2 Type & FLU syndromic testing out now
The CE-IVD version of the FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 from altona Diagnostics is available now. It’s an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus specific RNA in human respiratory swab specimens. The SARS-CoV-2 detection is based on the parallel detection of the E gene of lineage B-beta coronavirus (including SARS-CoV-2) and the S gene of SARS-CoV-2. Validated for use with the AltoStar® Automation System AM16 for nucleic acid extraction, the AltoStar® Internal Control 1.5 and the FlexStar® (RT-)PCR Amplification Mix 1.5.
The FlexStar® (RT-)PCR Amplification Mix 1.5 is also CE marked now. It’s an enzyme mix for in vitro diagnostic purposes – intended to be used with FlexStar® (RT-)PCR Detection Mixes for the real-time PCR based amplification and detection of pathogen specific nucleic acids in human specimen types.
The FlexStar® product line is the quick and flexible real-time PCR solution from altona. The optimized PCR design allows up to 96 results per real-time PCR cycler in just one hour. The FlexStar® products are combinable ready-to-use PCR assays for syndromic testing to simultaneously detect and identify pathogens. Thanks to the modular product design the FlexStar® (RT-)PCR Amplification Mix 1.5 can be used with any FlexStar® (RT-)PCR Detection Mix. This system also offers handling flexibility: it allows use in automated workflows and manual applications. FlexStar® complements altona’s existing AltoStar® and RealStar® portfolio to provide even more tailored solutions for your laboratory requirements.
The FlexStar® product range will provide more opportunities for syndromic-driven testing in 2022 including more respiratory as well as gastrointestinal and fever inducing pathogens. The product line will be further broadened by the addition of the FlexStar® sexually transmitted disease (STD) panel in 2023.