Evaluation of the Performance of Follicle-Stimulating Hormone (FSH) Rapid Test Cassette for Self-Testing in Menopause Detection

The Follicle-Stimulating Hormone (FSH) Rapid Test Cassette (Urine) is a chromatographic immunoassay specifically engineered for the qualitative detection of FSH in human urine specimens, playing a crucial role in assisting healthcare professionals in identifying perimenopause and menopause. This study was designed to conduct a comprehensive and systematic evaluation of its performance characteristics, encompassing sensitivity, specificity, accuracy, and clinical utility, by means of a direct comparison with another commercially available FSH rapid test. A total of 250 urine specimens were included in the analysis, with 85 confirmed as FSH-positive and 165 as FSH-negative through a validated reference method. The results of the evaluation revealed outstanding performance: the test achieved 100.0% relative sensitivity, meaning it correctly identified all positive specimens, 100.0% specificity, accurately ruling out all negative specimens, and 100.0% overall accuracy. Additionally, a Kappa value of 1 was obtained, which is the highest possible score for inter-method consistency, indicating perfect agreement with the reference method. Further testing confirmed that the cassette exhibits no cross-reactivity with luteinizing hormone (LH), human chorionic gonadotropin (hCG), or thyroid-stimulating hormone (TSH) at the specified concentrations, ensuring that results are not erroneously influenced by these related hormones. Moreover, the test maintained reliable and consistent performance under the recommended storage conditions, demonstrating its stability. These findings collectively confirm that the FSH Rapid Test Cassette is a reliable, rapid, and practical tool for the detection of elevated FSH levels, making it highly valuable for the timely assessment of menopausal status in clinical settings.