The LumiraDx SARS-CoV-2 Ag Test is used with the company’s multi-assay platform.
It is a microfluidic immunofluorescence assay that provides results for the qualitative nucleocapsid protein antigen detection directly in nasal swab samples obtained from the patient.
The WHO’s decision to include the antigen test in its EUL was based on a set of available data on quality, safety, performance and efficacy.
In clinical trials, the test showed 95% positive agreement versus RT-PCR in patients tested within 12 days of symptoms onset.
Additionally, it joins a select group of antigen tests included in the WHO EUL.
Delivering rapid results at the point of care, the test enables physicians to start appropriate treatment and patient management with immediate effect, maximising health outcomes while lowering further infection spread.
LumiraDx chief innovation officer Dr Nigel Lindner said: “The ongoing complexities of the evolving pandemic require multiple lines of defence.
“This important milestone lets us offer a reliable and affordable, high-performance testing alternative to better manage the pandemic burden and help reduce the strain on health systems worldwide.”
Earlier, LumiraDx collaborated with the Bill and Melinda Gates Foundation for the distribution of 5,000 Platforms in 49 African countries in various care settings.
They include primary healthcare facilities, field clinics, airports, occupational health settings and walk-through clinics.
The company has assays in the pipeline for treating TB, diabetes, HIV-AIDS and other health conditions, which would have the potential to make a positive impact on global health.
In February, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted approval for LumiraDx’s SARS-CoV-2 RNA STAR Complete assay.