User-Friendly Self-Testing Evaluation of SP-10 Male Fertility Rapid Test (OSP-902H) in Semen

Abstract

The SP-10 Male Fertility Rapid Test Cassette (OSP-902H) is a chromatographic immunoassay for qualitative detection of acrosomal protein SP-10 in human semen. This study evaluated its diagnostic performance using 114 clinical semen specimens (62 normal and 52 abnormal) compared with a Computer-Assisted Semen Analysis (CASA) reference method. The test demonstrated 98.1% sensitivity, 98.3% specificity, and 98.2% overall accuracy. No cross-reactivity or interference was observed with common interfering substances or biological fluids. Both intra- and inter-assay reproducibility achieved 100% consistency. These results confirm the SP-10 assay as a rapid, reliable, and user-friendly diagnostic tool for self-testing of male fertility.