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One Step - FSH Home Menopause Test Kit Midstream (Urine)
Package Insert - 25 mlU- For Self Testing
One Step - FSH Home Menopause Test Kit Midstream (Urine)
Package Insert - 25 mlU- For Self Testing
In women, elevated levels of FSH (follicle-stimulating hormone) is associated with low estrogen and the
stages of menopause.
In women, elevated levels of FSH (follicle-stimulating hormone) is associated with low estrogen and the
stages of menopause.
The FSH Menopause Test detects FSH in urine at concentrations of 25 mIU/ml or greater. It can help
you to determine if your hot flushes, irregular periods and other health symptoms are menopause
related.
The FSH Menopause Test detects FSH in urine at concentrations of 25 mIU/ml or greater. It can help
you to determine if your hot flushes, irregular periods and other health symptoms are menopause
related.
Test Kit includes 2 (two) FSH Home Menopause Tests and Complete Instructions.
Test Kit includes 2 (two) FSH Home Menopause Tests and Complete Instructions.
Directions for Use
Directions for Use
Read all instructions carefully.
Read all instructions carefully.
1. Remove the test device from the protective pouch.
2. Remove the plastic cap to expose the absorbent tip.
3. Hold the handle of the test device so that the tip is pointing downwards.
4. Urinate on the tip until it is thoroughly wet (about ten seconds)*.
5. Replace the cap over the tip and lay the device on a flat service with the window
facing up. Wait for the test result.
6. Read results at 5 minutes. Do not read after 10 minutes.
* Alternatively, you may urinate into a clean, dry cup or container; dip the tip into the urine for about ten
seconds.
1. Remove the test device from the protective pouch.
2. Remove the plastic cap to expose the absorbent tip.
3. Hold the handle of the test device so that the tip is pointing downwards.
4. Urinate on the absorbent tip until it is thoroughly wet (about ten seconds)*.
5. Replace the cap over the tip and lay the device on a flat service with the
window facing up. Wait for the test result.
6. Read results at 5 minutes. Do not read after 10 minutes.
* Alternatively, you may urinate into a clean, dry cup or container; dip the tip into the urine for about ten
seconds.
Note:
The first morning urine contains the highest level of FSH and is the best for testing. Urine collected
during the day will contain lower levels of FSH and may cause false negatives. Do not drink excess
fluids after midnight before testing in the morning. The test can taken at any time during your cycle and
that the second test should be taken 1 week later.
Note:
The first morning urine contains the highest level of FSH and is the best for testing. Urine collected
during the day will contain lower levels of FSH and may cause false negatives. Do not drink excess
fluids after midnight before testing in the morning. The test can taken at any time during your cycle and
that the second test should be taken 1 week later.
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Store at room temperature 15-30 C (59-86 F)
For in-vitro diagnostic use only. Not for internal use.
Keep away from children.
Each test should be used only once. Discard after use.
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


Store at room temperature 15-30 C (59-86 F)
For in-vitro diagnostic use only. Not for internal use.
Keep away from children.
Each test should be used only once. Discard after use.
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How to read the result
How to read the result
Keep the test device on a flat surface for 5 minutes and read the result. There should be a pink line
(control line) that appears in the small square control window to tell you that (1) the test is valid and (2)
the test is completed.
Keep the test device on a flat surface for 5 minutes and read the result. There should be a pink line
(control line) that appears in the small square control window to tell you that (1) the test is valid and (2)
the test is completed.
NEGATIVE
Two lines are visible, but the line in the test window (T) is lighter than the one in the
reference window (C), OR there is no line in the test window (T). This indicates that you are
probably not experiencing perimenopause in this cycle.
NEGATIVE
Two lines are visible, but the line in the test window (T) is lighter than the one in the
reference window (C), OR there is no line in the test window (T). This indicates that you are
probably not experiencing perimenopause in this cycle.
POSITIVE
Two lines are visible and the line in the test window (T) is the same as or darker than the
one in the reference window (C). This indicates that your FSH level is higher than normal
and you may be experiencing perimenopause. Testing should be repeated after 5 to 7 days.
POSITIVE
Two lines are visible and the line in the test window (T) is the same as or darker than the one
in the reference window (C). This indicates that your FSH level is higher than normal and you
may be experiencing perimenopause. Testing should be repeated after 5 to 7 days.
INVALID
Reference line fails to appear. The result is invalid if no red line appears in the reference
window (C), even if a line appears in the test window (T). You should repeat with a new
midstream test.
INVALID
Reference line fails to appear. The result is invalid if no red line appears in the reference
window (C), even if a line appears in the test window (T). You should repeat with a new
midstream test.
Understanding your results
Understanding your results
For women experiencing menopausal symptoms who have had no menstrual cycle for the past 12
months:
1st Test - Positive
Interpretation - Menopause has most likely occurred. You may want to repeat the test, but discuss the
results with your doctor to confirm them and discuss therapies to promote good health after menopause.
For women experiencing menopausal symptoms who have had no menstrual cycle for the past 12
months:
1st Test - Positive
Interpretation - Menopause has most likely occurred. You may want to repeat the test, but discuss the
results with your doctor to confirm them and discuss therapies to promote good health after
menopause.
For women experiencing perimenopausal symptoms plus irregular menstrual cycles:
1st Test – Positive, 2nd Test – Positive
Interpretation - Most likely in perimenopause. Discuss results with doctor. Do not discontinue
contraception.
1st Test – Positive, 2nd Test – Negative OR 1st Test – Negative, 2Nd Test – Positive
Interpretation - May be in early stages of perimenopause. Discuss results with doctor. Do not
discontinue contraception
1st Tests – Negative, 2nd Test - Negative
Interpretation - Most likely not experiencing perimenopause this cycle. If symptoms persist, repeat
testing in the following month or see your doctor about other possible causes for your symptoms.
Graphical Symbols Used
Lot
number
Expiry
date
For women experiencing perimenopausal symptoms plus irregular menstrual cycles:
1st Test – Positive, 2nd Test – Positive
Interpretation - Most likely in perimenopause. Discuss results with doctor. Do not discontinue
contraception.
1st Test – Positive, 2nd Test – Negative OR 1st Test – Negative, 2Nd Test – Positive
Interpretation - May be in early stages of perimenopause. Discuss results with doctor. Do not
discontinue contraception
1st Tests – Negative, 2nd Test - Negative
Interpretation - Most likely not experiencing perimenopause this cycle. If symptoms persist, repeat
testing in the following month or see your doctor about other possible causes for your symptoms.
Graphical Symbols Used
Manufacturer
D
Do not
reuse
Storage
temperature
In vitro
diagnostic device
AI DE Diagnostica Co. Ltd., 141 Zhu Zhou Road, Quingdao High–Tech Industrial Park, 266101 Shandong, P.R. China.
Distributed in the UK by Home Health UK Ltd Tel: 01923 711 511, Website: www.homehealth-uk.com, Email info@homehealth-uk.com
Read
instructions
before use
Lot
number
Expiry
date
Manufacturer
D
Do not
reuse
Storage
temperature
In vitro
diagnostic device
AI DE Diagnostica Co. Ltd., 141 Zhu Zhou Road, Quingdao High–Tech Industrial Park, 266101 Shandong, P.R. China.
Distributed in the UK by Home Health UK Ltd Tel: 01923 711 511, Website: www.homehealth-uk.com, Email info@homehealth-uk.com
Read
instructions
before use