LumiraDx has obtained the CE mark approval for two new high-sensitivity and high-throughput molecular tests, as part of the company’s Fast Lab Solutions.
The two tests include Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete.
The Dual-Target SARS-CoV-2 STAR Complete is a multiplex assay that simultaneously detects two gene markers to identify the presence of SARS-CoV-2.
It offers a 97.7% positive percent agreement (PPA) for SARS-CoV-2 and a 100% negative percent agreement (NPA) in symptomatic individuals, compared to RT-PCR.
The test will meet certain regulatory requirements in several regions that require two or more targets for a Covid-19 diagnostic, said LumiraDx.
The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete is designed for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2.
It offers a 94.1% PPA for SARS-CoV-2, and 92.3% for influenza A, and 95.7% for influenza B, along with more than 99.5% NPA, compared to high sensitivity RT-PCR.
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 the 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.”
LumiraDx Fast Lab Solutions supports high-complexity laboratory testing by using its advanced qSTAR nucleic acid amplification technology.
The technology leverages a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments.
Its continued work on the qSTAR technology has enabled it to develop multiplexing capabilities, said the molecular testing company.
LumiraDx is a UK-based next-generation point of care (POC) diagnostics company that manufactures and markets an advanced diagnostic testing platform.
It offers more than 30 tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform.
