High-Consistency and User-Friendly Self-Testing Evaluation of hCG for Pregnancy Detection in Urine
DOI:
https://doi.org/10.64149/J.Carcinog.24.10s.623-625Keywords:
Human Chorionic Gonadotropin (hCG); Pregnancy Rapid Test; Urine Specimen; Self-testing; Chromatographic Immunoassay.Abstract
The Pregnancy (hCG) Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine. This study evaluated its diagnostic performance using 608 urine specimens (231 positive, 377 negative) compared with a CE-certified reference test. Results demonstrated perfect agreement with the reference method, with both positive and negative coincidence rates reaching 100%. No cross-reactivity or interference was observed with physiological or pharmacological compounds, and intra-/inter-assay reproducibility exceeded 99%. These findings confirm that the test is a reliable, rapid, and user-friendly self-testing tool for early pregnancy detection, suitable for both clinical and home-based use.
