Mologic Ltd, Bedfordshire, UK, has received the CE mark for PeriPlex, a rapid, point-of-care test for the detection of infection in patients on peritoneal dialysis (PD). The company has also commercially launched the test, which has been developed to be used at home by patients or their carergivers to enable warning of infection within 10 minutes.
Globally, there are more than 200,000 patients being treated with PD, which is widely accepted as the preferred method for managing severe chronic kidney disease (CKD) and end-stage renal disease (ESRD). PD uses the peritoneum in a patient’s abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. It is used to remove 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, which can lead to peritonitis.
Using current methods, diagnosis of infection can take more than 24 hours, risking damage to the peritoneal membrane or the formation of scar tissue that can prevent the long-term use of PD. PeriPlex uses a lateral-flow immunoassay system to detect two critical biomarkers of infection in PD waste fluid, and provides results within 10 minutes. A positive result can give PD patients warning of an infection, prompting them to contact their healthcare provider to initiate antibiotic therapy. Earlier identification of infection can enable preemptive use of antibiotics, resulting in improved management of infection and prevention of infection-related damage to the peritoneal membrane.
“PeriPlex is the first of a pipeline of products from Mologic to receive CE mark approval,” says Mark Davis, cofounder and CEO at Mologic. “We are developing similar diagnostic tests for a range of disease areas, including sepsis, urinary tract infections, and chronic obstructive pulmonary disease. Each of these tests use lateral-flow immunoassay technology to detect a host inflammatory response for rapid, point-of-care diagnosis and, importantly, to enable earlier treatment for patients.”
For more information, visit Mologic.