FSH Rapid Test Cassette,Detection For Follicle Stimulating
Hormone,Women's Health Test Kit
| 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 |
INTENDED USE
The FSH Rapid Test Cassette (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 Cassette 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 adding a urine specimen to the specimen well
of the test device 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.
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 cassette from the sealed pouch and use it within one hour.
3. Place the test cassette on a clean and level surface. Hold the
sample dropper vertically and transfer 3 drops of urine
(approx.120ul) to the specimen well of the test cassette, and then
start the timer. Avoid trapping air bubbles in the specimen well.
See illustration below.
4. Wait for the colored line(s) to appear. Read the result at 3
minutes. Do not interpret the result after 10 minutes.
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.
| 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 |
