CE-Marked Immunoassay Rapidly Detects Infection Biomarkers

CE mark approval has been given for a point-of-care (POC) test for rapid detection of infection in patients on peritoneal dialysis (PD), enabling early diagnosis and treatment critical for preventing infection-related damage to the peritoneal membrane.

The test, PERiPLEX from Mologic (Bedford, UK), uses a lateral flow immunoassay system that provides results in under 10 minutes, developed especially for use at home by PD patients or their careers to enable early warning of infection, prompting them to contact their healthcare provider to initiate preemptive antibiotic therapy.

There are globally over 200,000 patients being treated with PD as the preferred method for managing severe chronic kidney disease (CKD) or end stage renal disease (ESRD). PD uses the peritoneum in a patient’s abdomen as a dialysis membrane for removing toxins and excess fluid, and to correct electrolyte problems in those with kidney failure.

However, PD is known to have a high rate of associated infections that can lead to peritonitis. Using current methods, diagnosis of infection can take over 24 hours, which risks damage to the peritoneal membrane, or formation of scar tissue can prevent long-term use of PD. PERiPLEX tests samples from PD waste fluid for two critical biomarkers of infection: interleukin-6 (IL-6) and matrix metalloproteinase-8 (MMP-8).

Mark Davis, co-founder and CEO at Mologic commented, “PERiPLEX is the first of a pipeline of products from Mologic to receive CE mark approval. We are developing similar diagnostic tests for a range of disease areas, including sepsis, urinary tract infections and chronic obstructive pulmonary disease (COPD). Each of these tests use lateral flow immunoassay technology to detect a host inflammatory response.”

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