Sample-to-answer assay delivers results in approximately 45 minutes from nasopharyngeal and nasal swab specimens.
Diasorin has received 510(k) clearance from the US Food and Drug Administration for its Simplexa COVID-19/Flu A/B & RSV Direct kit, a sample-to-answer test that detects SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) directly from nasopharyngeal and nasal swab specimens.
The assay runs on the LIAISON MDX system using the Direct Amplification Disc, enabling detection of all four respiratory pathogens in approximately 45 minutes. The test is designed for use in both hospital and commercial laboratories to support differential diagnosis of primary respiratory viruses that circulate during winter seasons.
The multiplexed approach addresses evolving market demands as laboratories shift from COVID-19-only testing to combined respiratory pathogen detection. Following the COVID-19 pandemic, both influenza virus and RSV have resurged, particularly since the 2022/2023 season, creating a need for simultaneous detection of these pathogens along with SARS-CoV-2 during peak infection periods, the company notes in a release.
Enhanced Multiplexing Capabilities
The new assay represents an advancement in Simplexa technology on the LIAISON MDX platform, achieving increased multiplexing capabilities while maintaining rapid turnaround times. The test provides broad coverage for influenza strains, emerging SARS-CoV-2 variants, and detection of both RSV subgroups A and B.
By enabling simultaneous detection of multiple respiratory pathogens, the test aims to improve diagnostic accuracy when clinical presentations may be ambiguous. This approach allows healthcare providers to develop more targeted treatment plans and implement appropriate infection control measures.
“We are excited to introduce our new four-plex test enabling detection of SARS-CoV-2, influenza A and B, and RSV, designed to meet the demands of today’s respiratory testing landscape,” says Angelo Rago, president of Luminex, which Diasorin acquired in 2021, in a release. “Our dedication to offering adaptable testing solutions is reflected in the addition of this four-plex kit to our range of COVID-19 and flu testing assays, ensuring that laboratories are equipped to handle dynamic respiratory seasons and evolving healthcare environments.”
The cleared assay complements DiaSorin’s existing LIAISON MDX respiratory portfolio, providing laboratories with options for single-pathogen or multiplexed respiratory testing based on clinical needs and testing volume requirements.
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