View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
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.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Medical Device Network