PRIMA Menopause FSH Home Test Self-test to determine follicle-stimulating hormone (FSH) levels in urine Contents: 2 tests MENOPAUSE AND FSH Menopause is a physiological process caused by a change in hormone levels in women. Menopause occurs when at least 12 consecutive months have passed without menstruation. Irregular menstrual cycles can therefore be an early indicator of the onset of menopause, or the so-called perimenopause. Menopause results from the depletion of ovarian follicles, which leads to elevated levels of circulating follicle-stimulating hormone (FSH). During menopause, FSH concentrations rise from values ​​below 20 mIU/mL to values ​​up to approximately 80 mIU/mL. WHO IS THE TEST FOR? The MENOPAUSE FSH TEST is for women experiencing symptoms related to menopause: absent menstrual cycles, hot flashes, sleep disturbances, and obvious mood swings. The hormonal changes associated with the onset of menopause generally occur around the age of 45, although the real signs appear around the age of 55. TECHNICAL DATA MENOPAUSE FSH TEST is an immunochromatographic device that detects the FSH hormone in urine thanks to special gold-conjugated monoclonal antibodies incorporated into the test strips. Specificity 86.9% Sensitivity 100% Accuracy 94% CONTENTS - 2 spoon devices - Instructions for use MISSION 1. Remove the protective cap and hold the absorbent tip directly under the urine stream for at least 10 seconds; 2. Alternatively, immerse the absorbent tip in a clean and dry container for 10 seconds; 3. Replace the protective cap on the spoon device and wait 5 minutes to read the result. INTERPRETATION OF THE RESULTS Negative: FSH levels are below the threshold. This suggests that menopause has probably not yet begun. Positive: The FSH concentration in the urine is equal to or greater than 25 mIU/mL. Repeat the test after 5-7 days, as FSH levels can fluctuate throughout the month. If the result is confirmed as positive, consult a doctor. QUESTIONS & ANSWERS: What happens if the times for reading the results are not adhered to? The test was performed correctly if the instructions for use were followed, including the reading time and the interpretation of the results as specified in the INTERPRETATION OF RESULTS section of the instructions for use. How can you verify if the test worked correctly? A colored line appears in the control area (C) of the test device, indicating that the test was performed correctly. If this line is not present, the test should be repeated with a new device and a new sample. How should the test be interpreted if the control and test lines show different intensities? The color and intensity of the bands are not important for interpreting the result. The test is considered positive regardless of the intensity of the test line color (T).