Fertility FSH One Step Menopause Test with CE certificate uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The FSH One Step Menopause Test is a rapid lateral flow chromatographic immunoassay for the qualitative detection of Follicle-Stimulating Hormone (FSH) level in urine to evaluate the onset of menopause in women.

Accuracy

A multi-center clinical evaluation was conducted comparing results obtained using the FSH One Step Menopause Test to another commercially available urine membrane FSH test. The study included 200 urine specimens, and both assays identified 120 negative and 78 positive results. The results demonstrated 99% accuracy of the FSH One Step Menopause Test when compared to the other urine membrane FSH test.

FSH One Step Test vs. Other FSH Rapid Test

Relative Sensitivity: 100.0% (93.3%-100.0%)* Relative Specificity: 97.7% (93.5%-99.5%)*

Relative Accuracy: 98.4% (95.3%-99.7%)* * 95% Confidence Intervals

Sensitivity and Specificity

The FSH One Step Menopause Test can detect FSH at concentrations of 25 mIU/mL or greater. The addition of LH (1,000 mIU/mL), hCG (100 IU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL FSH) and positive (25 mIU/mL FSH) specimens showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to FSH negative and positive specimens.

None of the substances at the concentrations tested interfered in the assay.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.