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June 9, 2022

LumiraDx obtains CE mark for two Fast Lab Solutions molecular tests

The two multiplex tests are developed using LumiraDx's qSTAR single-step nucleic acid extraction and amplification technology.

LumiraDx has obtained CE mark for two Fast Lab Solutions multiplex tests, SARS-CoV-2 & Flu A/B RNA STAR Complete and Dual-Target SARS-CoV-2 STAR Complete.

The new LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete multiplex assay has been designed to simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B viruses.

It uses nasopharyngeal or anterior nasal swabs collected from individuals who are suspected of Covid-19 and/or influenza by their healthcare provider.

Compared to high sensitivity RT-PCR tests, the multiplex assay has a positive percent agreement (PPA) of 92.3% for influenza A, 95.7% for influenza B and 94.1% for SARS-CoV-2 in symptomatic individuals.

It has a negative percent agreement (NPA) of more than 99.5%.

The LumiraDx Dual-Target SARS-CoV-2 STAR Complete multiplex assay is intended for the detection of nucleic acid from two gene markers to identify the presence of SARS-CoV-2 from nasopharyngeal or anterior nasal swabs from Covid-19 suspected individuals.

The company stated that the test has been developed to meet certain regulatory requirements in many regions that need two or more targets for Covid-19 diagnosis.

It also noted that the multiplex assay was demonstrated to have an NPA of 100% and PPA of 97.7% for SARS-CoV-2 in symptomatic individuals when compared to a high sensitivity RT-PCR.

The two tests are developed using the company’s qSTAR single-step nucleic acid extraction and amplification technology and provide results within 20 minutes.

LumiraDx Fast Lab Solutions president Sanjay Malkani said: “As the pandemic persists, we remain focused on bringing to market high-quality molecular diagnostics that further remove testing barriers and enhance laboratory operations.

“We are pleased to demonstrate unrivalled innovation with direct method, high-throughput, highly sensitive assays for open molecular platforms – with results available in 20 minutes – and the added benefit of accurately detecting influenza and Covid-19 from a single sample.”

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