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26th September 2022 Product update: rapidmicrobiology staff writer
Diasorin Simplexa™ COVID-19 Test Received FDA Clearance
The Simplexa™ COVID-19 Direct kit is a sample-to-answer test for the detection of SARS-CoV2 directly from nasopharyngeal swabs.
Designed for use on the Liaison® MDX platform the test is run directly through the direct amplification disc (DAD) delivering rapid detection in just over an hour.
The Simplexa™ COVID-19 Direct test differs from other automated PCR assays with extraction as it does not require sample pre-treatment, enabling a fast time-to-result, ultimately allowing prompt decision making regarding isolation and treatment of infected patients.
The test is highly specific for SARS-CoV-2 and targets two regions of the viral genome to minimize the impact of mutations on the kit performance with SARS-CoV-2 and potential variants of concern. This ensures the results remain highly sensitive and specific providing confidence in diagnostic decision making.
DiaSorin remains at the forefront of the fight against the spread of SARS-CoV-2 with a suite of COVID-19 molecular diagnostic products including the Simplexa™ SARS-CoV-2 Variants Direct (RUO) and has submitted to FDA for review the Simplexa™ COVID-19 & Flu A/B Direct assay for differential diagnosis during the flu season.
Date Published: 26th September 2022
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
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