FSH Rapid Test Midstream Rapid Test Kits Detection For Follicle
Stimulating Hormone-Dipstick
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Midstream |
| Specimen | Urine |
| Certificate | CE/CE0123 |
| Reading Time | 3 minutes |
| Pack | 2T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | ＞99.9% |
| Specificity | ＞99.9% |
| Accuracy | ＞99.9% |
| Cut-Off | 25 mIU/mL |
The FSH Rapid Test Dipstick (Urine) is a rapid chromatographic
immunoassay for the qualitative detection of follicle stimulating
hormone (FSH) in urine to aid in the detection of menopause.
SUMMARY
Menopause is the permanent cessation of menstruation but is usually
not scientifically diagnosed until one full year after a woman’s
menstrual periods have stopped. The period leading up to menopause,
and the 12 months following, is known as perimenopause. Many women
experience symptoms during this time including hot flashes,
irregular menstrual cycles, sleep disorders, vaginal dryness, hair
loss, anxiety and mood swings, short-term memory loss and fatigue.
The onset of perimenopause is caused by changes in the levels of
hormones in the female body that regulate the menstrual cycle. As
the body produces less and less estro/gen, it increases its
production of FSH, which normally regulates the development of a
female’s eggs.
Therefore, testing for FSH can help determine whether a woman is in
the perimenopause stage. If a woman knows she is perimenopausal,
she can take the appropriate steps to keep her body healthy and
avoid the health risks associated with menopause, which include
osteoporosis, increased blood pressure and cholesterol, and
increased risk of heart disease.
The FSH Rapid Test Dipstick is a rapid test that qualitatively
detects the FSH level in urine specimen at the sensitivity of 25
mIU/mL. The test utilizes a combination of antibodies including a
monoclonal anti-FSH antibody to selectively detect elevated levels
of FSH.
PRINCIPLE
The FSH Rapid Test Dipstick is a qualitative, lateral flow
immunoassay for the qualitative detection of human Follicle
Stimulating Hormone in urine to evaluate the onset of menopause in
women. The test utilizes a combination of antibodies including a
monoclonal anti-FSH antibody to selectively detect elevated levels
of FSH.
The assay is conducted by immersing the test strip in a urine
specimen and observing the formation of colored lines. The specimen
migrates via capillary action along the membrane to react with the
colored conjugate. Positive specimens react with the specific
antibody-FSH colored conjugate to form a colored line at the test
line region of the membrane which is darker than or the same shade
as the line in the control line
region.
To serve as a procedural control, a colored line will always appear
in the control line region, indicating that the proper volume of
specimen has been added and membrane wicking has occurred
DIRECTIONS FOR USE
Allow the test, urine specimen and/or controls to reach room
temperature (15- 30°C) prior to testing.
1. Determine the day to begin testing. (See the above section:
“WHEN TO START TESTING”).
2. Bring the pouch or closed canister to room temperature before
opening it. Remove the test dipstick from the sealed pouch or
closed canister and use it as soon as possible.
NOTE: For canister packaging, immediately close the canister
tightly after removing the required number of the test dipstick(s).
Record the initial opening date on the canister. Once the canister
has been opened, the remaining test dipstick(s) are stable for 90
days only.
3. With arrows pointing toward the urine specimen, immerse the test
dipstick vertically in the urine specimen for at least 10-15
seconds. Do not pass the maximum line (MAX) on the test dipstick
when immersing the dipstick. See illustration below.
4. Place the test dipstick on a non-absorbent flat surface, start
the timer and wait for the colored line(s) to appear. Read results
at 3 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: Two lines are visible and the line in test line region
(T) is the same as or darker than the line in the control line
region (C). A positive result means that the FSH level is higher
than normal. Record the results and see the chart below to
interpret results.
NEGATIVE: Two lines are visible, but the line in the test line
region (T) is lighter than the line in the control line region (C),
or there is no line in the test line region (T). A negative result
means that the FSH level is not elevated at this time.
Record the results and see the chart below to interpret results.
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
Sensitivity and Specificity
The FSH Rapid Test Dipstick can detect FSH at concentrations of 25
mIU/mL or greater. The addition of LH (1,000 mIU/mL), hCG (100
mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL FSH) and
positive (25 mIU/mL FSH) specimens showed no cross-reactivity
Positive Agreement: 100.0% (96.6%-100.0%)*
Negative Agreement: 100% (95.7%-99.9%)*
Overall Agreement: 100% (97.1%-99.9%)*
*95% Confidence Interval
Order Information
| Cat. No. | Product | Specimen | Pack |
| FFS-101 | FSH Rapid Test Dipstick | Urine | 50T |
| FFS-102 | FSH Rapid Test Cassette | Urine | 40T |
| FFS-103 | FSH Rapid Test Midstream | Urine | 2T |
| FFS-101H | FSH Rapid Test Dipstick(Self-Testing) | Urine | 2T |
| FFS-102H | FSH Rapid Test Cassette(Self-Testing) | Urine | 2T |
| FFS-103H | FSH Rapid Test Midstream(Self-Testing) | Urine | 2T |
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