A new rapid, noninvasive test that can detect infections among peritoneal dialysis (PD) patients has earned the “Conformité Européene” (CE) mark. This mark means that a product may be marketed within the European Economic Area.
The regulatory submissions are supported by positive results from a Phase 3 S-TRAC, (Sunitinib Trial in Adjuvant Renal Cancer) study.
Mologic (Thurleigh, Bedfordshire, UK) has launched the point-of-care test PERiPLEX. The test was created for use in the home by PD patients or their caregivers, and takes 10 minutes for a result.
Peritonitis at the PD catheter insertion site traditionally has been detected when the patient or caregiver notices a change in the color, opaqueness, or aroma of PD fluid when it is being disposed. Patients with advanced infection may detect a change in their sense of well-being if there is an infection. If infection is suspected, a microbiologic test is ordered, Mologic says.
The company notes that traditional microbiological methods can take at least 24 hours for a result. Because of the rapid results from the PERiPLEX test, antibiotic treatment may begin sooner. Quick treatment is crucial in warding off further problems, including damage to the peritoneal membrane used in PD.
PERiPLEX finds two recognized markers of infection using a lateral flow immunoassay system. The markers are interleukin 6 (IL6) and matrix metalloproteinase 8 (MMP8).
The test includes a hypodermic needle that pierces a PD waste bag to gather and pass waste peritoneal dialysate from the patient to the test strip. When present in the patient’s dialysate, MMP8 and IL6 are picked up by antibodies carried on the surface of gold nanoparticles. The nanoparticles carrying MMP8 or IL6 are then captured and appear as up to two separate lines across the strip, colored red in positive samples. The test is the first of several point-of-care tests that Mologic has in its pipeline, CEO Mark Davis said.
