LumiraDx’s HbA1c test seals European approval for diabetes screening

UNITED KINGDOM – LumiraDx, a healthcare company that manufactures a diagnostic platform to support a menu of tests has reported that its HbA1c test received CE mark for the screening and monitoring of people with diabetes in the point of care (POC) setting.

Delivering rapid results at the point of care, the test enables physicians to start appropriate treatment and patient management with immediate effect, maximizing health outcomes.

The rapid microfluidic immunofluorescence assay is used with the portable LumiraDx Platform and provides results in less than seven minutes from sample application.

Furthermore, the automated, quantitative fingerstick assay can aid in screening and detecting patients at risk of developing diabetes.

Adding HbA1c to the LumiraDx test menu also facilitates the merging of various instruments to a single POC Platform with a shared workflow. The new HbA1c test has a reportable range of 20 to 130 mmol/mol HbA1c.

According to data from an external, multisite clinical trial, the test was shown to attain a precision of ≤2.50% in capillary and venous whole blood as measured by mean paired replicate percent coefficient of variation (%CV).

The HbA1c test is intended to meet the rising clinical demand for reliable HbA1c testing in the community healthcare setting.

The test will be offered on the same POC Platform as the company’s high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool and SARS-CoV-2 Ag Ultra as well as INR, D-Dimer and CRP tests.

LumiraDx CEO Ron Zwanziger said: “With our growing test menu, the LumiraDx Platform is able to quickly and accurately support clinicians with a variety of diagnostic and treatment decisions at the point of care.

HbA1c is an important addition to our platform not only for our existing pharmacy and primary care customers but for new customers looking to consolidate their current testing needs into one centralized and streamlined, connected platform that delivers lab comparable performance.”

The latest development comes after the World Health Organization (WHO) granted Emergency Use Listing (EUL) for the company’s rapid antigen assay for Covid-19 detection.

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.

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 is also developing assays for treating tuberculosis, diabetes, HIV/AIDS, and other diseases that have the potential to improve global health.

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