Clinical evaluation
Clinical performance was evaluated using 360 samples, with results compared against PCR reference testing, an established
molecular laboratory method that detects Giardia by identifying and amplifying its DNA.
In this evaluation, the test demonstrated 97.5% sensitivity and 96.0% specificity. 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.