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 feline herpesvirus and feline calicivirus genetic material.
In these evaluations, the test demonstrated 96.00% sensitivity and 98.33% specificity for FHV, and 97.00% sensitivity and 99.20% specificity for FCV. The evaluation included 500 samples for FHV and 350 samples for FCV. 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.