PRIMA MENOPAUSE FSH Self Test Instruction Manual

: June 12, 2024
: PRIMA

Table of Contents

PRIMA MENOPAUSE FSH Self Test
THE FSH HORMONE AND MENOPAUSE
TEST PRINCIPLE
REFERENCES
CONTENT
PRECAUTIONS
TEST PROCEDURE
RESULTS INTERPRETATION
F.A.Q. – QUESTIONS AND ANSWERS
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

PRIMA MENOPAUSE FSH Self Test

Self-Test for the determination of the Follicle Stimulating Hormone – FSH in urine

THE FSH HORMONE AND MENOPAUSE

The menopause is caused by a modification of the hormonal balance in woman’s 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). Menopause is the consequence of the end of ovary follicle life-cycle leading to increase of Follicle Stimulating Hormone (FSH) circulating level. Concentration of FSH increases during menopause passing from values less than 20 mUI/mL up to approximately 80 mUI/mL. MENOPAUSE FSH TEST can detect the presence of FSH in urine as soon as the concentration goes up from 25 mIU/mL and over.

TEST PRINCIPLE

MENOPAUSE FSH TEST is an immunochromatographic test that detects FSH through special goldconjugated monoclonal antibodies included in the reactive strip.

REFERENCES

1. Robert J. Norman “Fertility testing” Australian Prescriber, 2002;25:38-401
2. Buckler H. “The menopause transition: endocrine changes and clinical symptoms.” J Br Menopause Soc. 2005 Jun;11(2):61-5.
3. National Collaborating Centre for Women’s and Children’s Health (UK) “Menopause: Full Guideline”. 2015 Nov. National Institute for Health and Care Excellence: Clinical Guidelines.

CONTENT

The number of the testing devices of the kit may vary. For the exact number of tests contained, please refer to the “content” section on the external box.
- hermetically sealed aluminium pouches containing each:
- 1 device for the MENOPAUSE FSH TESTincluding a protective cap 1 desiccant bag
1 instructions for use leaflet
- Do not open the sealed aluminium pouch until just before performing the test. Take care to open it as marked.
- The desiccant bag must not be used. Dispose of it with household waste without opening it.
- Material required but not supplied: a device to measure time (i.e. timer, watch).

PRECAUTIONS

Read these instructions for use carefully before performing the test. The Test is reliable only if all the instructions are followed correctly.
Keep the Test out of the reach of children.
Do not use the Test after the expiry date or if the package has been damaged.
Follow the indicated procedure and time strictly.
Store the Test components at a temperature between +4°C and +30°C. Do not freeze.
Use the test once only.
The test is for external use only. DO NOT SWALLOW.
In vitro diagnostic device for individual use.
After using, please dispose of all components according to your local waste disposal laws. Ask your pharmacist for advice.

TEST PROCEDURE

Open the protective bag and take out the Test device. Dispose of the desiccant packet contained in the aluminium bag.
Remove the protective cap – this exposes the absorbing tip. –fig.A Rotate the device so that the results window faces up and the absorbing tip faces down.
Place the absorbing tip right under the flow of urine for at least 10 seconds. –fig.B1
WARNING: Ensure no drops of urine splash onto the reading window. Alternatively (if easier), urine can be collected in a clean, dry, residue- free container (not supplied) and the absorbing tip can be dipped into the urine for 10 seconds –fig.B2
Place the protective cap back onto the absorbing tip. –fig.C
Put the test stick onto a dry, flat surface with the results window facing up. –fig.D

RESULTS INTERPRETATION

READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the line colours is not relevant for the purposes of interpretation of the Test’s results.

POSITIVE RESULT
Two coloured bands appear in the results window in the T (Test) and C (Control) regions. The T (Test) band may be less intense (lighter) than the C (Control) line. This means that the concentration of the follicle-stimulating hormone (FSH) in the urine is equal to or higher than 25 mIU/mL. In this case, the test should be repeated after 5-7 days because the concentration of FSH varies during the month. If a positive result is confirmed, the menopause process may have started and you should speak to your gynecologist.

NEGATIVE RESULTS
A coloured line appears only in the C (Control) region. This means that the concentration of FSH in the urine is below 25 mIU/mL and that probably the menopause process has not started yet.

NON VALID RESULT
No line appears in the C (Control) region and it is impossible to interpret the result of the test, which must be considered not valid. You should repeat the test with a new MENOPAUSE FSH TEST and a new urine sample.
The most frequent causes of incorrect use are:

the absorbing tip was immersed in the urine for too long or not long enough;
drops of urine splashed onto the results window while the tip was under the urine flow.

F.A.Q. – QUESTIONS AND ANSWERS

HOW DOES MENOPAUSE FSH TEST WORK?
The device specifically identifies human FSH and reveals if the concentration of that hormone in the urine is equal to or above 25 mIU/mL. In some cases, samples with FSH concentration below this value (between 21 mIU/mL and 24.99 mIU/mL) can yield a positive result. The Test was calibrated on the 2nd International Standard NIBSC 08/282.

WHEN CAN THE TEST BE PERFORMED?
The test can be carried out at any time of the month.

AT WHAT TIME OF THE DAY SHOULD THE TEST BE CARRIED OUT?
The test can be carried out at any time of the day. However, the morning’s first urine contains higher levels of FSH, which allow to obtain the best results.

CAN THE RESULTS BE INCORRECT?
The correct results are obtained if the instructions are followed correctly. However, there may be incorrect results if moisture ends up on the device before the test is carried out. Additionally, in rare cases, the results may be erroneously positive in young women (who are suffering from hormonal or metabolic disorders). In the case of unexpected or contradictory results, you should talk to your gynecologist, because some health conditions may alter the test’s results.

IF THE ABSORBING TIP IS LEFT IN THE URINE FOR MORE THAN 10 SECONDS, IS THE RESULT CORRECT?
Yes, a few seconds more do not interfere with the result.

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

WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
If you have a positive result the first time, you must repeat the test after 5-7 days. If the second test is positive, FSH levels have remained high for an anomalous period of time, so it is possible that the menopause process has begun. Speak to your gynecologist.

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

CAN THE TEST BE USED AS BIRTH CONTROL?
No, the test has not been designed for that purpose and it must not be used for that purpose.

DOES GOING OFF ORAL CONTRACEPTIVES (THE PILL) INTERFERE WITH THE RESULTS?
For some time after you stopped taking oral contraceptives, your periods may be irregular, which could interfere with the results. You should wait about two months before performing the test.

WHY, AFTER REACHING MENOPAUSAL AGE AND WITH POSITIVE RESULTS IN THE TEST, PERIODS CAN STILL LAST AS NORMAL?
A positive test means that FSH levels in the urine are above 25 mIU/mL, which means the menopause may be beginning. Menopause is defined as having no periods for 12 consecutive months in the absence of any other causes. However, in women this biological change is gradual and is preceded by a period called perimenopause, which can vary in duration. The reason for positive results while still having periods may mean you are in perimenopause.

WHAT IS THE ACCURACY OF MENOPAUSE FSH TEST?
Assessment reports show a concordance rate above 94% (CI 95%: 92.0 – 95.9%) with reference methods.

PRIMA LAB SA Via Antonio Monti 7 CH-6828 Balerna – SWITZERLAND