LumiraDx receives CE marking after successful CRP test

12 January 2022 | Wednesday | News

- Rapid microfluidic fluorescent immunological analysis for the quantitative determination of C-reactive protein (CRP) in capillary blood, venous whole blood and plasma samples in the range of 5.0 - 250.0 mg /
LumiraDx CRP Test

LumiraDx CRP Test

  • Quantitative results within 4 minutes of sampling facilitate rapid clinical decision-making at the point of care (POC)

LumiraDx (Nasdaq: LMDX),a company specializing in diagnosing next-generation care sites, today announced that it has received ce marking for its C-reactive protein test. The LumiraDx CRP test is a small portable, fully automated microfluidic immunological test used to quantify C-reactive protein with results within four minutes. Measuring CRP provides important information for identifying and assessing infection and inflammation. In patients with symptoms of respiratory infections, especially suspected pneumonia1, a sufficiently high CRP indicates the need for treatment with antibiotics, while a normal or low level of CRP suggests that patients have a viral or local infection that does not require antibiotics.

- Automated CRP testing for professional use in primary and social care settings, at home and in hospitals to quickly identify infection, tissue damage and inflammation, and in treatment decisions, including the need for antibiotics for respiratory infections

- Available on a single portable POC platform with highly sensitive LumiraDx tests for COVID-19 and influenza A/B antigen, COVID-19 antibodies, COVID-19 quantitative analysis, INR and D-Dimer tests

The LumiraDx CRP test accurately measures indicators in capillary blood samples, venous whole blood and plasma in the range from 5.0 to 250.0 mg / L. The test is carried out on the LumiraDx platform, which can be used by the patient as part of primary and social care, at home and in hospitals, providing fast and reliable test results for timely decision-making.

Doctors may use the LumiraDx CRP test to assess infections, tissue injuries, and inflammation. Test results can also provide valuable information to reduce unnecessary antibiotic prescribing as part of an overall effort to combat antimicrobial resistance. In fact, while antibiotic consumption in England has declined during the pandemic2, recent studies have found high rates of antibiotic prescribing to COVID-19 patients, illustrating the unnecessary use of antibiotics and fears that antibiotic-resistant infections could return to pre-pandemic levels.2

"Antimicrobial resistance is a growing concern around the world, and if left unchecked, it will lead to a serious health crisis. Although the causes of antimicrobial resistance are complex, a growing body of evidence suggests that improving the clinical diagnosis of respiratory infections in patients is a key component in combating the unnecessary administration of antibiotics, said ProfessorJonathan Cooke,Visiting Professor in the Department of Surgery and Cancer at the Faculty of Medicine at Imperial College London. "Access to CRP-POCT rapid diagnostics has been demonstrated to support healthcare providers in prescribing decisions and helps improve the treatment of respiratory infections."

LumiraDx Chairman and CEO Ron Zwanziger explained: "The inclusion of CRP in the LumiraDx platform will be crucial this season of respiratory infections to provide physicians with a variety of tools to help assess patients' illnesses and their need for antibiotic treatment. Incorporating the test into the LumiraDx platform, along with our COVID-19 and flu A/B tests, will allow doctors to make important decisions during the treatment phase."


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