Female Fertility Midstream/Menopause Test Kits FSH Test Strip One Step Hormonal Disorders Analysis
[INTRODUCTION]
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
[PRODUCT FEATURE]
Easy to Use
Fast Result
High Accuracy
Good Quality
[Principle]
The FSH One Step Menopause Test Device (Urine) is a qualitative, lateral flow immunoassay for the qualitative detection of human Follicle-Stimulating Hormone in urine to evaluate the onset of menopause in women. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-FSH-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
[MAIN COMPONENTS]
The test contains anti-FSH particles and anti-FSH coated on the membrane.
[Storage Conditions And Shelf Life]
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.
[Materials Provided]
Materials Required But Not Provided:
- Specimen collection container
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[Sample Requirements]
The urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred since it generally contains the highest concentration of FSH; however, urine specimens collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
[ When To Start Testing]
If the subject is still having monthly periods, then the first test should be taken during the first week of her menstrual cycle (Days 2-7, with Day 1 being the first day of menstruation). Repeat with the second test 1 week later.
If the subject is no longer having regular periods, the first test should be taken at any time during the month and the second test should be taken 1 week later.
[Testing Method]
Allow the test, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
- Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 mL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
- Wait for the colored line(s) to appear. Read results at 3 minutes. Do not read the result after 10 minutes.
[Results interpretation]
(Please refer to the illustration above)
POSITIVE: Two lines are visible, and the line in test line region (T) is the same as or darker than the one in the control line region (C). This indicates probable ovulation in 24-36 hours.
NEGATIVE: Two lines are visible, but the line in the test line region (T) is lighter than the one in the control line region (C), or if there is no line in the test line region (T). This indicates that no LH surge has been detected.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
[Quality control]
A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.It is recommended that a positive FSH control (containing 25-250 mIU/mL FSH) and a negative FSH control (containing 0 mIU/mL FSH) be evaluated to verify proper test performance when a new shipment of tests is received.
[Accuracy]
A multi-center clinical evaluation was conducted comparing results obtained using the FSH One Step Menopause Test Device (Urine) 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 Device (Urine) when compared to the other urine membrane FSH test.
Testsealabs FSH Test Device vs. Other FSH Rapid Test
| Method |
Other FSH Rapid Test |
Total Results |
FSH One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
78 |
2 |
80 |
| Negative |
0 |
120 |
120 |
| Total Results |
78 |
122 |
200 |
Relative Sensitivity: 99.9% (94.4%-100.0%)*
Relative Specificity: 98.4% (93.9%-99.9%)*
Relative Accuracy: 99.0% (96.2%-99.9%)*
* 95% Confidence Intervals
Audited Supplier 
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