LumiraDx C-Reactive Protein (CRP) Test Achieves CE Marking

LumiraDx (London, UK) has achieved CE Marking for its C-reactive protein (CRP) Test, a small, portable, fully automated, microfluidic immunoassay test used for the quantitative determination of C-reactive protein with results within four minutes.

The measurement of CRP provides important information for the detection and evaluation of infection, and inflammation. In patients with respiratory infection symptoms, especially suspected pneumonia1, significantly high CRP suggests the need for antibiotic treatment, whereas normal or low CRP levels suggest patients have viral or self-limiting infection that does not require antibiotics. The LumiraDx CRP Test accurately measures direct fingerstick, venous whole blood, and plasma samples within a range of 5.0 - 250.0 mg/L. The assay is run on the LumiraDx Platform, which can be used at the patient side in primary and community care, patient homes and in hospital emergency care settings providing fast, reliable test results for timely decision making.

Clinicians can use the LumiraDx CRP test in the assessment of infection, tissue injury, and inflammatory conditions. Insights from the test can also provide valuable information to reduce unnecessary antibiotic prescribing, in an overall effort to fight antimicrobial resistance. In fact, while the consumption of antibiotics in England declined during the pandemic, recent studies have highlighted high rates of antibiotic prescribing among COVID-19 patients illustrating the unnecessary use of antibiotics and fear that antibiotic-resistant infections may return to pre-pandemic levels. Shipments of the LumiraDx CRP Test will begin shortly. The announcement comes on the heels of the company announcing the CE Mark for the LumiraDx SARS-CoV-2 & Flu A/B Antigen Test just last month.

"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," said Ron Zwanziger, LumiraDx Chairman and CEO. "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."

"Antimicrobial resistance is a growing concern across the globe, and if left unaddressed will lead to a serious public health crisis. While the causes of antimicrobial resistance are complex, growing evidence suggests that improving the clinical diagnosis of respiratory infections in patients is a key component in tackling unnecessary antibiotic prescribing rates," added Professor Jonathan Cooke, visiting Professor in the Department of Surgery and Cancer, Faculty of Medicine at Imperial College London. "Having access to rapid CRP-POCT diagnostic tools has been shown to support healthcare providers when making prescribing decisions and helps improve the management of respiratory infections."

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