Prima Home Test Menopause FSH Test

Overview

Prima Home Test Menopause FSH Test
Self-Test for the determination of Follicle Stimulating Hormone – FSH in urine
MENOPAUSE & FSH:
Menopause is a physiological event caused by a change in women’s hormonal balance. We talk abouy “menopause” when at least 12 consecutive months have elapsed in the absence of menstruation.
The irregularity of menstrual cycles can therefore be a first indicator of the onset of menopause, or rather of the so-called “perimenopause”. Menopause is the consequence of the depletion of ovarian follicles leading to increased levels of circulating follicle stimulating hormone (FSH). FSH concentrations increase in menopause from values below 20 mUI/mL to values up to approximately 80 mUI/mL.
WHO IS THIS TEST FOR?
MENOPAUSE FSH TEST is indicated for women who begin to experience symptoms related to menopause: lack of menstrual cycles, hot flashes, sleep irregularities and obvious mood changes.
The change in hormonal balance associated with the onset of menopause generally occurs around age 45, although the real signs appear around age 55.
TECH SPECS:
MENOPAUSE FSH TEST is an immunochromatographic device that detects the FSH hormone in urine thanks to special gold-conjugated monoclonal antibodies incorporated in the test strip.
Specificity     86.9%
Sensitivity     100%
Accuracy     94%
CONTENT:
2 spoon devices
instructions for use
USE PROCEDURE:
1.Remove the protective cap and place the absorbing tip right under the flow of urine for at least 10 seconds;
2.Alternatively, collect the urine in a clean and dry container and dip the absorbing tip into the urine for 10 seconds;
3.Place the protective cap back onto the spoon device and wait 5 minutes before reading the result.
RESULTS INTERPRETATION:
Negative – FSH levels are below the cut-off. This indicates that the menopause process has probably not started yet.
Positive – FSH concentration in urine is equal to or greater than 25mUI/mL. Repeat the test after 5-7 days, as FSH levels can vary throughout the month. In case of confirmation of positivity, consult a specialist.
BIBLIOGRAPHY:
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.
F.A.Q.:
What happens if the results reading time is not met?
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the “RESULTS INTERPRETATION” section of the instructions for use.
How to prove that the test worked correctly?
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
How to interpret the test if the control and test lines have different intensities?
The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).