REF:

C1109 (Strip)

C1110 (Cassette)

C1111 (Midstream Stick)

INTENDED PURPOSE:

NOVAtest® One Step FSH Urine Test offered a rapid, visually read and qualitative test for women. The user can evaluate onset of menopause by testing her urine sample with this double-antibody sandwich method of lateral flow immunoassay. This test is entirely manual by the user.

INTENDED USER:

Performance of the test is limited to self-testing at home. The test can be applied to any women.

SUMMARY:

The follicle-stimulating hormone (FSH) is a glycoprotein hormone present in human blood and urine. FSH plays a crucial role in the synthesis and secretion of steroid hormones. Structurally, FSH consists of alpha and beta subunits, with the beta subunit conferring its specific biological activity.

During menopause, ovarian function declines, leading to a decrease in oestrogen secretion. This decline triggers the hypothalamus to release more FSH in order to stimulate the remaining follicles. Consequently, elevated levels of FSH are commonly observed in menopausal women, indicating diminished ovarian function.

The early stage before menopause is known as perimenopause. During this stage, FSH levels may rise above normal and gradually return to baseline, resulting in irregular or missed periods.

NOVAtest® One Step FSH Urine Test is intended use as an aid of diagnostic tool for detecting perimenopause.