Fertility FSH One Step Menopause Test with CE certificate uncut
sheet
| Product Name | FSH One Step Menopause Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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.
Interfering Substances
The following potentially interfering substances were added to FSH
negative and positive specimens.
| Acetaminophen | 20 mg/dL | Caffeine | 20 mg/dL |
| Acetylsalicylic Acid | 20 mg/dL | Gentisic Acid | 20 mg/dL |
| Ascorbic Acid | 20 mg/dL | Glucose | 2 g/dL |
| Acetoacetic Acid | 2 g/dL | Hemoglobin | 500 mg/dL |
| Bilirubin | 100 mg/dL | | |
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.
