LumiraDx has secured US Food and Drug Administration (FDA) Emergency Use Authorization as well as UK Health Security Agency (UKHSA) validation for a multiplex test for Covid-19 and influenza A and B.
The multiplex Covid and influenza molecular test, named LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay, allows laboratories to quickly identify and differentiate individuals with respiratory viral infections consistent with Covid-19.
Clinical signs and symptoms of influenza and SARS-CoV-2 respiratory virus infections can be identical, making correct identification essential for treating patients, LumiraDx said.
The multiplex test allows for the concurrent detection and differentiation of influenza A, influenza B and SARS-CoV-2 infections within a period of 20 minutes or less.
Furthermore, it makes use of qSTAR technology, which allows direct amplification and high throughput on open molecular platforms to provide highly sensitive results.
LumiraDx Molecular Diagnostics Business president Sanjay Malkani said: “With the limited number of direct amplification multi-analyte tests available, we believe that this test will become a fundamental tool for the detection and differentiation of SARS-CoV-2 from influenza.
“As the burden of respiratory illness continues, we look forward to providing our clinical diagnostic lab and reference lab customers with a high-throughput, highly sensitive multiplex test with results available in 20 minutes – and the added benefit of accurately detecting influenza and Covid from a single sample.”
LumiraDx plans to begin commercialisation of the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay in the US and UK.
It was initially launched in the European Union and other markets that accept the CE-IVD marking last June.