Classification: | Biological Diagnostics |
---|---|
Type: | Test Strips & Test Tube, Urine/Hematology Analyzer |
Certification: | CE, MSDS, ISO13485, CE, ISO13485 |
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Application
The FSH Rapid Test Dipstick ( Urine) is a repid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone(FSH) in urine to aid in the detection of menopause.
1.Self-detection of ovarian function
2.Prevention of premature ovarian
3.Diagnosis of menopause
Direction of Use
Allow the test, urine specimen and /or control to reach room temperature(15-30ºC) prior to test in.
Determine the day to begin test.
Bring the pouch or canister to room temperature before opening it. Remove the test Dipstick from the sealed pouch or closed canister and use it as soon as possible.
With arrows pointing toward the urine specimen for at least 15 seconds. Do not pass the maximum line (MAX) on the test Dipstick when immersing the Dipstick. See illustration below.
Place the test Dipstick on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. The result should be read at 3 minutes
INTERPRETATION RESULT (Please refer to the illustration)
Positive: Two lines are visible and the line in 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. Record the results and see the chart below to interpret result.
Negative: Two lines 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 line in the test line region (T). A negative result means that the FSH level is not elevates at this time. Record the results and see the chart below to interpret result.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control the 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.
Test Interpretation
Review the result of both tests ( if applicable) and interpret according to the chart below.
For patients experiencing premenopausal symptoms plus irregular menstrual cycles:
1st test |
2nd test |
Interpretation |
Positive |
Positive |
Most likely in perimenopause. Discuss with patient methods and therapies to promote good health after menopause. Patient should NOT immediately discontinue contraception. |
Positive |
Negative |
May be in early stages of perimenopause. Patient should NOT immediately discontinue contraception. |
OR |
||
Negative |
Positive |
|
Negative |
Negative |
Most likely not experiencing perimenopause this cycle. If symptoms persist, repeat patient testing in the following month or review other possible causes for symptoms. |
For the patients experiencing menopausal symptoms who have had NO menstrual cycle for the past 12months:
1st Test |
Interpretation |
Positive |
Menopause has most likely occurred. Test may be repeated. Discuss with patient methods and therapies to promote good health after menopause. |