Performance Evaluation of Ovulation (LH) Rapid Test Midstream (Urine) for Self-Testing via Clinical Validation
DOI:
https://doi.org/10.64149/Keywords:
Ovulation; Luteinizing Hormone (LH); Rapid Immunochromatographic Assay; Self-Testing; Clinical Validation; Fertile Window.Abstract
The Ovulation (LH) Rapid Test Midstream (Urine) is a chromatographic immunoassay designed for the qualitative detection of luteinizing hormone (LH) in human urine. This study evaluated its diagnostic performance using 300 urine specimens (76 positive and 224 negative) compared with a validated commercial reference test. The results demonstrated excellent accuracy, with both positive and negative coincidence rates reaching 100%. No cross-reactivity or interference was observed with related hormones, including FSH, hCG, and TSH. These findings confirm the assay’s reliability, reproducibility, and suitability for home-based self-testing. The device serves as an efficient, user-friendly, and non-invasive tool for identifying the fertile window, thus facilitating family planning and conception management.
