Clinical evaluation
Clinical performance was evaluated using separate sample sets, with results compared against PCR reference testing, an established molecular laboratory method used to detect the genetic material of canine parvovirus, canine coronavirus and Giardia. The evaluation included 300 samples for CPV, 350 samples for CCV and 360 samples for Giardia.
In these evaluations, the test demonstrated 98.00% sensitivity and 98.67% specificity for CPV, 98.50% sensitivity and 97.33% specificity for CCV, and 97.50% sensitivity and 96.00% specificity for Giardia. Sensitivity describes the test’s ability to identify positive samples, while specificity describes its ability to identify negative samples.
Quality-controlled manufacturing
Manufactured in a specialist IVD facility operating under an ISO 13485:2016-certified quality management system. Controlled processes cover raw materials, production, packaging and final inspection.
Production includes controlled manufacturing processes, in-process inspections and batch-level quality checks before release. These measures help support consistent quality and reliable test performance.