Multiplex RT-PCR assay detects SARS-CoV-2, influenza A and B, and RSV from nasal swabs with breakaway format for flexible testing.
Molecular Designs has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Simplicity DX Respiratory Panel, a multiplex real-time RT-PCR assay designed for simultaneous detection of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus.
The in vitro diagnostic (IVD) panel detects viral RNA in anterior nasal swabs and includes two targets for SARS-CoV-2, one each for influenza A and B, and two for RSV, alongside an internal control to validate run performance.
“Submitting our IVD product to the FDA is an important milestone,” says Michael Clark, CEO of Molecular Designs, in a release. “It reflects our commitment to giving labs tools that are not only clinically sound but also practical and efficient to use. Our goal is to help labs streamline testing workflows without sacrificing accuracy or flexibility.”
Breakaway Format to Reduce Waste
The panel features a breakaway format designed to allow laboratories to use only the tests needed during each run, potentially helping reduce waste, manage inventory more efficiently, and lower costs.
The format supports batch processing and reduces the need for repeated control runs, which could help laboratories handle larger volumes without adding extra workload, according to the Birmingham, Alabama-based company.
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