Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| Sample Type | Urine |
| User | Professional |
| Accuracy | 99% |
| Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| After-sales Service | Available |
| Key words | FSH One Step Menopause Test |
| For the crowd | women |
| Brand Name | Aichek |
| Model Number | FSH-A01 |
| Certification | CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | Storage | 2℃-30℃ |
| Sample Type | Urine | User | Professional |
| Accuracy | 99% | Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable | Formats | 25T/box 1T/box |
| After-sales Service | Available | Key words | FSH One Step Menopause Test |
| For the crowd | women | Brand Name | Aichek |
| Model Number | FSH-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | One Step FSH Menopause Test ，FSH Menopause Test Kit ，Women Fertility Rapid Test | ||
| 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.
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.
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
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.
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.
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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