Fertility FSH One Step Menopause Test with CE certificate Test Device

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.

SUMMARY

Menopause is the permanent cessation of menstruation but is usually not scientifically diagnosed until one full year after a woman’s menstrual periods have stopped. The period leading up to menopause, and the 12 months following, is known as perimenopause. Many women experience symptoms during this time including hot flashes, irregular menstrual cycles, sleep disorders, vaginal dryness, hair loss, anxiety and mood swings, short-term memory loss and fatigue. The onset of perimenopause is caused by changes in the levels of hormones in the female body that regulate the menstrual cycle. As the body produces less and less estrogen, it increases its production of FSH, which normally regulates the development of a female’s eggs.^{1, 2, 3} Therefore, testing for FSH can help determine whether a woman is in the perimenopause stage. If a woman knows she is perimenopausal, she can take the appropriate steps to keep her body healthy and avoid the health risks associated with menopause, which include osteoporosis, increased blood pressure and cholesterol, and increased risk of heart disease.^4,5

The FSH One Step Menopause Test is a rapid test that qualitatively detects the FSH level in urine specimen at the sensitivity of 25 mIU/mL. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. At the level of claimed sensitivity, the FSH One Step MenopauseTest shows no cross-reactivity interference from the structurally related glycoprotein hormones hCG, hLH and hTSH at high physiological levels.