LumiraDx Limited has achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete.
These high-sensitivity and high-throughput tests help to expand testing capabilities across the globe.
LumiraDx’s continued innovation of its qSTAR technology, which utilises a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, has led to the development of multiplexing capabilities.
The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay allows for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2.
SARS-CoV-2 & Flu A/B RNA STAR Complete compares to high sensitivity RT-PCR with a positive percent agreement (PPA) of 94.1% for SARS-CoV-2, and 92.3% for influenza A, and 95.7% for influenza B and a negative percent agreement (NPA) of >99.5% in symptomatic individuals.
The Dual-Target SARS-CoV-2 STAR Complete multiplex assay simultaneously detects two gene markers to identify the presence of SARS-CoV-2, which will meet certain regulatory requirements in numerous regions that need two or more targets for a COVID-19 diagnostic.
Compared to a high sensitivity RT-PCR, Dual-Target SARS-CoV-2 STAR Complete proved to have a PPA of 97.7% for SARS-CoV-2 and a NPA of 100% in symptomatic individuals.
“As the pandemic persists, we remain focused on bringing to market high-quality molecular diagnostics that further remove testing barriers and enhance laboratory operations,” explained Sanjay Malkani, President of LumiraDx Fast Lab Solutions.
He continued:
“We are pleased to demonstrate unrivaled 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.”
LumiraDx Fast Lab Solutions supports high-complexity laboratory testing by utilising its innovative qSTAR nucleic acid amplification technology in an accessible high-throughput format to leverage current molecular laboratory operations.
Utilising Fast Lab Solutions enables laboratories to improve efficiency and reduce time to result.
