Follicle Stimulating Hormone Rapid Test Self-Testing, Midstream
Format, Women's Health Test Kit
| Principle | Chromatographic Immunoassay |
| Format | Midstream |
| Specimen | Urine |
| Certificate | CE/CE0123 |
| Reading Time | 3 minutes |
| Pack | 2T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | ＞99.9% |
| Specificity | ＞99.9% |
| Accuracy | ＞99.9% |
| Cut-Off | 25 mIU/mL |
A rapid test for the qualitative detection of follicle stimulating
hormone (FSH) in urine.
For professional in vitro diagnostic use only.
INTENDED USE
The FSH Rapid Test Midstream (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 Midstream 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 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 urinate on or immersing the test midstream 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. FSH present in the specimen binds
to the conjugate, forming a colored antibody-antigen complex. The
FSH antibody immobilized in the test zone of the membrane captures
the FSH-Conjugate (antibody + signal reagent) complex in the test
region and the rabbit antibody immobilized in the control zone of
the membrane
captures the conjugate in the control region.
Two lines are thus visible. If the line in test line region is same
as or darker than the line in the control line region, it indicates
a positive result. If the line in the test line region is lighter
than the line in the control line region; or if there is no line in
the test line region, it indicates a negative result. To serve as a
procedural control, a colored line will always appear in the
control line region, indicating that proper volume of specimen has
been added and membrane wicking has occurred.
WHEN TO START TESTING
If the subject is still having monthly periods, then the first test
should be taken during the first week of her menstrual cycle (Days
2-7, with Day 1 being the first day of menstruation). Repeat with
the second test 1 week later.
If the subject is no longer having regular periods, the first test
should be taken at any time during the month and the second test
should be taken 1 week later.
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 to room temperature before opening it. Remove
the test midstream from the sealed pouch and use it as soon as
possible.
3. Take down the cap of the midstream, then urinate on it or place
the absorbent tip(≥2/3) into urine sample in a clean cup at least
15seconds(see illustration below).
4. Cover the cap on the testing midstream, then lay down the
product on a clean and stable desk with the test and control window
face upwards, and then start the timer immediately.
5. As the test begins to work, you may notice a light colored flow
moving across the test and control window. Read the result at 3
minutes. Do not interpret the result after 10 minutes.
LIMITATIONS】
1. The test works only when the test procedures are precisely
followed.
2. Do not reuse the test device.
3. For professional in vitro diagnostic use only.
4. Oral contraceptive and pregnancy may affect the test and produce
inaccurate results.
5. The test may not be used to determine fertility. It cannot be
used to determine the ability to become pregnant. Contraception
decisions should not be made based on the results of this test
alone.
6. Keep out of the reach of children
| 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 |
