MENOPAUSE FSH TEST – 2 Tests

Description

GENERAL

THE FSH HORMONE AND MENOPAUSE
Menopause is caused by a change in the hormonal balance in the woman's body. This change usually occurs around age 45. But the real signs are observed around the age of 55. An irregular menstrual cycle is an early indication of the onset of menopause (peri-menopause). Menopause results from the end of the ovarian follicle cycle, leading to an increase in circulating follicle-stimulating hormone (FSH). The concentration of FSH increases during menopause from less than 20 mUI/mL to approximately 80 mUI/mL. The MENOPAUSE FSH TEST can detect the presence of FSH in the urine as soon as the concentration increases from 25 mIU/mL.

TEST PRINCIPLE
MENOPAUSE FSH TEST is an immunochromatographic test that detects FSH via special gold-conjugated monoclonal antibodies in the reactive strip.

MANUAL:
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TEST PROCEDURE:
1) Open the protective bag and take out the test device. Discard the desiccant bag in the aluminum bag
2) Remove the protective cap - this will expose the absorbent end. –fig.A
Turn the device so that the results window points upwards and the absorbent tip points downwards.
3) Place the absorbent tip directly under the urine stream for at least 10 seconds. –fig.B1

WARNING: Do not allow drops of urine to splash onto the reading window.
You can also (if easier) collect urine in a clean, dry, residue-free container (not supplied) and immerse the absorbent tip in the urine for 10 seconds –fig.B2
4) Place the protective cap back on the absorbent tip. –fig.C
5) Place the test on a dry, flat surface with the window facing up. –fig.D

INTERPRETATION OF THE RESULTS:
READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the line colors is not relevant to the interpretation of the test results.

POSITIVE RESULT
Two colored bands appear in the reading window at the characters T (test) and C (control). The T (Test) line may be less intense (lighter) than the C line. This means that the concentration of follicle stimulating hormone (FSH) in the urine is equal to or higher than 25 mIU/mL.
In that case, the test should be repeated after 5-7 days because the FSH concentration varies over the month.
If the result is positive, the menopause process may have begun and you should contact your gynecologist.

NEGATIVE RESULTS
A colored line appears only under the C (control) character.
This means that the concentration of FSH in the urine is less than 25 mIU/mL and that the menopause process has probably not yet started.

INVALID RESULT
No line appears in the C (Control) area and it is impossible to interpret the result of the test, which should be considered invalid. You must repeat the test with a new MENOPAUSE FSH TEST and a new urine sample.

The most common causes of incorrect use are:
a) the absorbent tip was immersed in the urine for too long or not long enough;
b) drops of urine splashed on the results window while the tip was under the urine stream.

HOW DOES THE MENOPAUSE FSH TEST WORK?
The device specifically identifies human FSH and shows whether the concentration of that hormone in urine is equal to or greater than 25 mIU/mL. In some cases, samples with an FSH concentration
Below this value (between 21 mIU/mL and 24,99 mIU/mL) will produce a positive result. The test is calibrated to the 2nd international standard NIBSC 08/282.

WHEN CAN THE TEST BE USED?
The test can be performed at any time of the month.

AT WHAT TIME OF THE DAY SHOULD THE TEST BE CARRIED OUT?
The test can be performed at any time of the day. However, the first urine of the morning contains a higher FSH level, which allows the best results to be obtained.

COULD THE RESULT BE WRONG?
Correct results will be obtained if the instructions are followed correctly. However, incorrect results may be obtained if moisture gets on the device before the test is performed. In addition, in rare cases the results may be falsely positive in young women (suffering from hormonal or metabolic disorders). In case of unexpected or contradictory results, you should consult with your gynecologist, as some health conditions can change the results of the test.

IF THE ABSORBENT TIP IS LEFT IN THE URINE FOR MORE THAN 10 SECONDS, IS THE RESULT CORRECT?
Yes, a few seconds longer will not affect the result.

IF THE ABSORBENT TIP IS LEFT IN THE URINE FOR LESS THAN 5 SECONDS, IS THE RESULT CORRECT?
No, because the amount of sample absorbed may not be sufficient.

WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
If you have a positive result the first time, you should repeat the test after 5-7 days. If the second test is positive, FSH levels have remained abnormally high for an abnormally long time, so it is possible that the menopause process has begun. Contact your gynaecologist.

WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
If the result is negative, the FSH level in the urine is less than 25 mIU/mL, which means that the menopause process has not yet started. However, if you experience menopausal symptoms, you should repeat the test after 40-60 days, or consult a gynecologist.

CAN THE TEST BE USED AS BIRTH CONTROL?
No, the test is not designed for that and should not be used for that purpose.

DOES STOPPING ORAL CONTRACEPTIONS (THE PILL) AFFECT THE RESULTS?
After you stop taking oral contraceptives, your periods may be irregular for a while, which can affect results. You should wait about two months before taking the test.

WHY CAN MENSTRATION STILL PROCEED NORMALLY AFTER MENOPAUSE AND WITH A POSITIVE TEST RESULT?
A positive test means that the FSH level in the urine is higher than 25 mIU/mL, which means that menopause may be starting. Menopause is defined as the absence of menstruation for 12 consecutive months without other causes. In women, however, this biological change is gradual and preceded by a period called perimenopause, the duration of which can vary. A positive result while you are still menstruating may mean you are in perimenopause.

WHAT IS THE ACCURACY OF THE FSH TEST FOR MENOPAUSE?
Assessment reports show a concordance rate of 94% (CI 95%: 92,0 – 95,9%) with reference methods.