Reliable Self-Testing Evaluation of Digital HCG Detection in Urine for Pregnancy Diagnosis

Abstract

The Digital hCG Pregnancy Test (Urine) is a self-administered in vitro diagnostic (IVD) device designed for qualitative detection of human chorionic gonadotropin (hCG) in urine. This study assessed its diagnostic performance using 67 urine samples (20 positive and 47 negative) compared with a validated commercial reference test. Results demonstrated 100% sensitivity, 100% specificity, and 100% overall accuracy. No cross-reactivity or interference was observed with common biological substances, and both intra-assay and inter-assay reproducibility achieved 100%. These findings confirm that the AllTest Digital hCG kit is a reliable, accessible, and user-friendly tool for home-based pregnancy self-testing.