Rapid self-test for detection of follicle-stimulating hormone (FSH) in urine.
Summary and Explanation
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 51 years old. A menstrual cycle duration getting irregular is the early indication of the beginning menopause (peri-menopause). The follicle stimulating hormone (FSH) is a hormone which increases during menopause.
The MENO-CHECK® is a manual qualitative immunochromatographic screening test for the detection of FSH (follicle stimulating hormone) in women’s urine. It can be used at home by lay users for self-testing for the detection of FSH concentration higher than 25 mIU/mL.
Precautions
- This test is designed for in vitro diagnostic use only. For external use only. DO NOT SWALLOW.
- Carefully read the instructions for use before performing the test. The test is reliable only if the instructions are carefully respected.
- Store between +4°C and +30°C. Do not freeze.
- Do not use after the expiry date printed on the external package and on the aluminium pouch or if one of the components is damaged.
- Do not reuse the MENO-CHECK® test.
- Keep out of reach of children.
- Do not use if you are pregnant or under hormonal treatment or if you are using, or have recently stopped using, patch or oral contraceptives.
- After use, all components can be discarded in a dustbin.
Procedure
- Remove the MENO-CHECK® test device from the protective pouch by tearing along the split. Discard the desiccant bag.
- Remove the cap of the MENO-CHECK® device. Turn MENO-CHECK® device so that the side, without the display window, is facing towards you and the absorbent tip is directed down wards.
- 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. If you prefer, it is possible to collect your urine in a clean and dry container (not provided), without any residue and dip the absorbent tip into the urine for at least 10 seconds.
- Replace the cap on the MENO-CHECK® test device. The urine sample thus comes into contact with the specific reagents which starts the test.
- Place the MENO-CHECK® test device on a dry flat surface with the window facing up.
- Read the results after 10 minutes. Do not interpret the results after 15 minutes.
Results Interpretation
To interpret the results, it is necessary to compare the coloration of the FSH line (Test window) with the coloration of the Control line (Control window).
Positive result
The result is positive if the coloration of the FSH line is more or equally intense 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 confirmed, you could be under menopausal process and you are advised to consult your gynaecologist for a definitive diagnostic.
Negative result
The result is negative if the Control line is darker than the FSH line or if there is no FSH line at all. This result 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.
Invalid result
When no Control line appears, the test is invalid. In this case, it is not possible to interpret the test and 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 level 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 Organization
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 in the morning contains a large quantity of FSH and allows the best results to be obtained.
Is it possible to get incorrect results?
The results are accurate as long as the instructions for use are carefully followed. 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 or during hormonal treatment). In case of unexpected or contradictory results, it is recommended to consult a gynaecologist, 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 should be performed 5 or 7 days later. If a positive result is again obtained with a second test, the FSH level was elevated over an unusual period and could therefore indicate you are under menopausal process. You should consult your gynaecologist to confirm or not the diagnosis of menopause.
What should I do if the result is negative?
If the result is negative, the FSH level is lower than 25 mIU/mL which means you are not probably under menopausal process. However, if you feel signs of menopause as indicated above, it is recommended to perform another test 40 to 60 days later or consult your gynaecologist. In addition, the volume of ingested liquids may affect the test results (dilution of FSH).
Should the test be used as contraception method?
No, the test has not been designed for this purpose and should not be used for this purpose.
Will discontinuing my hormonal contraception (pill) affect the result?
If you use a contraceptive and that you have just discontinued it, it is possible that your cycles may be irregular for some time, which may affect the result. It is recommended 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/mL which means that you are possibly under menopausal process. The menopause is defined as the cease of menstruation over a period of 12 months. However this biological change in a woman life is gradual and is preceded by a sooner or later period which is named peri-menopause. So the test result could be positive while your menstrual cycle duration is still regular. This means that maybe you are in peri-menopause phase.
What is the accuracy of MENO-CHECK®?
The MENO-CHECK® test is very accurate and has been used for more than 20 years by professionals in the field. Evaluation reports show an overall agreement of 94.29% (CI 95% [87.46 – 97.99] **) with reference method. Although this test is reliable, false positive or false negative results could be obtained.