Fertility FSH One Step Menopause Test with CE certificate Test
Device
| Product Name | FSH One Step Menopause Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
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
| Method | Other FSH Rapid Test | Total Results |
FSH One Step Test | Results | Positive | Negative |
| Positive | 53 | 3 | 56 |
| Negative | 0 | 129 | 129 |
| Total Results | 53 | 132 | 185 |
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.
