The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved LumiraDx’s SARS-CoV-2 RNA STAR Complete.
Developed with non-isothermal nucleic acid amplification qSTAR technology, the new rapid Covid-19 molecular assay is designed to detect nucleic acid from SARS-CoV-2 in upper respiratory swabs collected from Covid-19 suspects by a healthcare provider (HCP).
It uses a one step direct method for extracting and amplifying nucleic acid on validated open RT-PCR instruments.
Validated by Coronavirus Test Device Approvals (CTDA), LumiraDx SARS-CoV-2 RNA STAR Complete provides results within 20 minutes and contributes to the efficiency and productivity of labs.
The new assay is also authorised for use by non-symptomatic individuals, as well as others without reason to suspect Covid-19, when either self-collected under a HCP’s supervision or by a HCP.
The test showed a positive agreement of 95.4% compared to another high sensitivity RT-PCR assay in clinical trials.
LumiraDx chief commercial officer David Walton said: “Since the start of the pandemic, we have been pleased to support the UK healthcare system with our LumiraDx SARS-CoV-2 Antigen test, providing high sensitivity Covid-19 antigen testing in emergency departments, healthcare clinics, pharmacies and nursing homes.
“With CDTA and MHRA approvals of LumiraDx SARS-CoV-2 RNA STAR Complete, we look forward to partnering with our service partners to provide high throughput, high sensitivity and high-efficiency Covid-19 molecular testing.
“With the capability to process samples up to ten times faster than traditional RT-PCR methods, we are seeing broad customer demand for testing at multiple settings including airports, events and other public venues.”
The company’s SARS-CoV-2 Antigen Test also received UK CTDA and MHRA approval earlier this month.
Last month, LumiraDx announced that its Covid-19 antigen test is capable of detecting the Omicron variant.