The test will help detect SARS-CoV-2 viral nucleic acid within 20 minutes or less on common open channel PCR systems


LumiraDx RNA STAR Complete SARS-CoV-2 test box. (Credit: PRNewswire / LumiraDx Limited)

UK-based LumiraDx has secured CE mark approval for its high sensitivity, high throughput RNA STAR Complete SARS-CoV-2 test.

The test secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in October last year. The status was again reissued in March this year.

The RNA STAR Complete test, which is part of the LumiraDx’s Fast Lab Solutions, is a rapid and nucleic acid amplification method for high sensitivity, high throughput Covid-19 testing.

It is said to help laboratories to increase the throughput of their existing open channel PCR systems to more than 250 tests per hour.

The qualitative selective temperature amplification reaction (qSTAR) technology is used by the LumiraDx Covid-19 test. The technology is said to be the basis of LumiraDx’s point of care molecular assays.

Last year, the technology was used to introduce Fast Lab Solutions, a business unit established to expand existing laboratory testing capacity.

LumiraDx Fast Lab Solutions president: “Our innovative qSTAR technology simplifies and accelerates Covid-19 molecular testing capacity without comprising high sensitivity of detection.

“In addition, with the small footprint associated with our technology, we are able to bring this testing outside of the laboratory and into mobile units to deliver accurate and trusted results in environments where quick turnaround times are crucial.”

LumiraDx RNA STAR Complete SARS-CoV-2 deploys a direct amplification method, which aggregates lysis and amplification in a single step to detect SARS-CoV-2 viral nucleic acid within 20 minutes or less on common open channel PCR systems.

In June, LumiraDx announced the official commercial launch of its SARS-CoV-2 Ag Pool Test in Europe.

The test is designed to offer a rapid and scalable screening solution for infectious individuals, using the LumiraDx platform that delivers lab comparable diagnostic results at the point of care in minutes.

Currently, LumiraDx employs more than 1,200 people worldwide.