Skip to main content
Premium Trial:

Request an Annual Quote

LumiraDx Gets CE Mark for C-Reactive Protein Test

NEW YORK — LumiraDx said on Tuesday that it has received CE marking for its C-reactive protein test.

The LumiraDx CRP Test is a portable, fully automated microfluidic immunoassay for the quantitative determination of C-reactive protein in direct fingerstick, venous whole blood, and plasma samples. The test runs on the LumiraDx platform and provides results within four minutes.

According to the company, CRP measurement is used for the detection and evaluation of infection and inflammation. In patients with respiratory infection symptoms, for instance, significantly high CRP suggests the need for antibiotic treatment, whereas normal or low CRP levels suggest patients have a viral or self-limiting infection that does not require antibiotics, it said.

"The addition of CRP onto the LumiraDx platform will be critical this respiratory season to provide clinicians with a variety of tools to aid in the assessment of patients and their need for antibiotic treatment," Ron Zwanziger, LumiraDx's chairman and CEO, said in a statement. "Including the assay on the LumiraDx platform along with our COVID-19 and Flu A/B tests will enable clinicians to make important treatment decisions at the point of care."

UK-based LumiraDx received CE marking for its point-of-care SARS-CoV-2 & Flu A/B Antigen Test last month.