Meno-Check
Overview
Rapid selft-test for detection of follicle-stimulating hormone (FSH) level in urine. (menopause)
The menopause is caused by a modification of the hormonal balance in woman body. This change arises generally when close to 45 years old. But true signs are observed around 55 years old. A menstrual cycle duration getting irregular is the early indication of the beginning menopause (peri-menopause). The follicle stimulating hormone (FSH) is an hormone which increases during menopause. MENO-CHECK® can detect the presence of FSH in urine as soon as the concentration goes up from 25 mIU/mL and over.
Who is the test for?
Individuals to determine their menopausal status through the detection of follicle-stimulating hormone levels in urine.
How to use
- Remove the test device from the pouch, discard the desiccant pouch.
- Hold the absorbent tip directly in your urine stream for 5 to 10 seconds. Make sure that no drop of urine penetrate into the window of the test and Control areas. It is also possible if you prefer, with the absorbent tip downward, immerse it in urine for 5-10 seconds or collect urine in a separate container.
- Replace the cap, place the device on a flat surface, and read results after 10 minutes. Do not interpretthe results after 15 minutes
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Results and recommendations
The test is positive
The result is positive if the FSH line is darker than the Control line.
This result means that the FSH level is equal or higher than 25 mIU/mL. In this case, a second test must be performed 5 or 7 days later as the concentration of FSH can change during the menstrual cycle. If the positive result is confi rmed, you could be under menopausal process and you are advised to consult your gynaecologist for a defi nitive diagnostic.
The test is negative
The result is negative if the Control line is darker than the FSH line.
This results means that the concentration of FSH is lower than 25 mIU/mL and that you are probably not under menopausal process. Caution: in some cases, the FSH line may not develop at all.
The test is invalid
When no Control line develops, it is not possible to interpret the test, which must be considered as invalid. In this case, it is recommended to repeat the test with a new MENO-CHECK® and a fresh urine sample.
Questions and answers
How does MENO-CHECK® test work?
In women, the average hormonal cycle lasts 28 days. The FSH (Follicle Stimulating Hormone) secretion induces the follicle maturation, and LH (Luteinizing Hormone) secretion induces ovulation. The determination of FSH and LH level is indicated for the detection of amenorrhea and anovulatory cycles. Menopause arises at the mean age of 51 years old, i.e. between 45 and 55 years old depending on the female individuals. Menopause is caused by a significant change in the balance of hormones. An irregular menstrual cycle duration is often the first sign of a beginning menopause. Other signs like hot flush, insomnia, palpitations, mouth ulcers, gingivitis, hair loss, dry vagina, osteoporosis, chills or excessive sweating could indicate menopause.
The MENO-CHECK® test is a test for the determination of high levels of Follicle Stimulating Hormone in urine which is an indicator of menopause. The MENO-CHECK® test uses a pair of antibodies for the specific detection of the human FSH. A control line capturing the excess of reagent appears in the control zone of the test. In case of positive result, it means that the FSH concentration is higher of 25 mIU/mL (as determined against W.H.O.* reference).
*World Health Organisation
When the test could be used?
The test could be used at any time of the menstrual cycle.
What is the best moment to use the test?
You can perform the test at any moment of the day; however, the first urine inthe morning contains a large quantity of FSH and allows the best results to beobtained.
Is it possible to get incorrect results?
The results are accurate as long as the directions for use are carefullyfollowed. Nevertheless, the result can be incorrect if the MENO-CHECK®test is damp before performing the test. Moreover, the MENO-CHECK®test could be exceptionally distorted (positive result for a young woman). Incase of unexpected or contradictory results, it is recommended to consult agynaecologist, as some health problems can induce incorrect diagnosis.
I left the absorbent tip in urine for more than 10 seconds. Will I get an accurate result?
Yes. A few more seconds will not affect the results.
I left the absorbent tip in urine for less than 5 seconds. Will I get an accurate result?
No, because the sample volume might be insufficient.
What should I do if the result is positive?
If the result is positive with the first MENO-CHECK® test, a second test shouldbe performed 5 or 7 days later. If a positive result is again obtained with asecond test, the FSH level was elevated over an unusual period and couldtherefore indicate you are under menopausal process. You should consult yourgynaecologist to confirm or not the diagnosis of menopause.
What do I have to do if the result is negative?
If the result is negative, the FSH level is lower than 25 mIU/mL which means youare not probably under menopausal process.
However, if you feel signs of menopause as indicated above, it is recommendedto perform another test 40 to 60 days later or consult your gynaecologist.
Should the test be used as contraception method?
No, the test has not been designed for this purpose and should not be used forthis purpose.
Will discontinuing my hormonal contraception (pill) affect the result?
If you use a contraceptive and that you have just discontinued it, it is possiblethat your cycles may be irregular for some time, which may affect the result. It isrecommended to wait for two cycles before using the MENO-CHECK® tests.
I have reached the age to be menopausal. I have performed the test which result was positive but my menstrual cycle duration is still regular. Why?
A positive test indicates that the FSH level is equal or higher than 25 mIU/mLwhich means that you are possibly under menopausal process. The menopauseis defined as the cease of menstruation over a period of 12 months. Howeverthis biological change in a woman life is gradual and is preceded by a sooner orlater period which is named peri-menopause. So the test result could be positivewhile your menstrual cycle duration is still regular. This means that maybe youare in peri-menopause phase.
What is the accuracy of MENO-CHECK®?
The MENO-CHECK® test is very accurate and has been used for more than10 years by professionals in the field. Evaluation reports show an overallagreement of 92.8% with reference method. Although this test is reliable, falsepositive or false negative results could be obtained.