【INTENDEDUSE】
The FSH Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause. For professional in vitro diagnostic use only.
【CONTENTS】
• FSH Rapid Test with desiccant.
• Instruction manual.
【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. 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. The FSH Rapid 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.
【PRINCIPLE】
The FSH Rapid Test 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 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 which is darker than or the same shade as the line in the Control Line Region. 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.
【SPECIMENCOLLECTION】
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.
【WHENTOTEST】
• 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.
【OPERATION】
1. Remove test Strip, Device or Midstream from the sealed pouch.
2.1 Strip: Remove test strip from the sealed pouch. Dip the arrowed end of the test strip into the container with urine sample, take it out in 10 seconds and lay flat.
2.2 Device/Cassette: Remove test device/cassette from the sealed pouch. Lay the device flat, add 2 drops of urine specimen by sample dropper into the sample well.
2.3 Midstream/Pen: Remove test midstream from the sealed pouch. Open the midstream cup, dip the sample collection head into urine sample, take it out in 10 seconds and lay it flat. 3. Read the results at 10 minutes.
【INTERPRETATIONOFRESULTS】
POSITIVE: Two lines are visible and the color intensity of the line in the Test Line Region (T) is the same as or darker than the line in the Control Line Region (C). A positive result means that the FSH level is higher than normal. NEGATIVE RESULT: Twolines are visible, but the line in the Test Line Region (T) is lighter than the line in the Control Line Region (C), or there is no visible line in theTest Line Region (T). A negative result means that the FSH level is not elevated at this time. INVALID: If there is no line in the Control Line Region (C) after 3-4 minutes, the result is invalid. The test should be repeated. The test is not reusable. The most likely reasons for an invalid result are that not enough urine specimen was used, or the test was performed the wrong way. Review the Directions for Use and repeat with a new test. If the problem persists, discontinue using the test kit and contact your distributor.
【PRECAUTIONS】
• Do not use after expiration date.
• The test should remain in the sealed pouch until use. Do not use the test if pouch is damaged.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
• Humidity and temperature can adversely affect results.
【STORAGEANDSTABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【LIMITATION】
•The test works only when the test procedures are precisely followed.
•Do not reuse the test.
•For professional in vitro diagnostic use only.
•Oral contraceptive and pregnancy may affect the test and produce inaccurate results.
•The test cannot be used to determine fertility. It cannot be used to determine the ability to become pregnant. Contraception decisions should not be made based on the results of this test alone.
•Keep out of the reach of children.
PERFORMANCE
Accuracy A multi-center clinical evaluation was conducted comparing results obtained using the FSH Rapid Test to another commercially available urine membrane FSH test. The results of the study, which included 250 urine specimens, demonstrated 99.2 % accuracy of the FSH Rapid Test when compared to the other urine membrane FSH test. Dewei FSH Rapid Test vs. Other FSH Rapid Test
| Method |
Other FSH Rapid Test |
Total results |
| Dewei FSH Rapid Test |
Results |
Positive |
Negative |
| Positive |
99 |
2 |
101 |
| Negative |
0 |
160 |
160 |
| Total Results |
99 |
162 |
261 |
Positive Agreement >99.99%; Negative Agreement: 98.77% ; Overall Agreement: 99.23% Sensitivity and Specificity The FSH Rapid 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. Interference The following potentially interfering substances were added to FSH negative and positive specimens.
Bilirubin 1000 mg/dL
None of the substances at the concentrations tested interfered in the assay.
For further operation or performance details, please refer to final instruction manual.
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