FSH Follicle Stimulating Hormone Test Cassette

FSH is a glycoprotein hormone. Its physiological function could promote endometrium growth, ovulating, stimulating follicle develop for female animals and stimulate spermatogenesis for male animals. It can promote Proliferation of granulosa cells, stimulate steroidogenesis, adjust gamete cell development and maturation, the hypothalamus -Pituitary – gonadal axis in one of the major hormones. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the FSH in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, levels of FSH as low as 25mlU/ml can be detected.

Features

• Fast read in 10 minutes
• High relative accuracy 99.3% (95%CI*: 97.8%-99.8%)
• Relative Sensitivity 97.6% (95%CI*: 85.5%-100%)
• Relative Specificity 99.5% (95%CI*: 98.0%-100%)

Follicle Stimulating Hormone(FSH) Test（Cassette）

Operating Instructions

SUMMARY AND EXPLANATION

FSH is a glycoprotein hormone. Its physiological function could promote endometrium growth, ovulating, stimulating follicle develop for female animals and stimulate spermatogenesis for male animals. It can promote Proliferation of granulosa cells, stimulate steroidogenesis, adjust gamete cell development and maturation, the hypothalamus -Pituitary - gonadal axis in one of the major hormones. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the FSH in the test samples with an extremely high degree of sensitivity.  In less than 5 minutes, levels of FSH as low as 25mlU/ml can be detected.

INTENDED USE

HENSO Follicle Stimulating Hormone(FSH) Test is a rapid chromatographic immunoassay for the qualitative detection of FSH in urine samples .It be used for the qualitative detection of human urine follicle stimulating hormone (FSH) levels for the diagnosis of female menopause.

CONTENTS, STORAGE AND STABILITY

Each box contains: 3 foil pouches and Operating Instructions.

Each pouch contains: 1 Step Follicle Stimulating Hormone(FSH) Test Strip and 1 Desiccant.

The test kit can be stored at room temperature (35.6F-86F; 2℃-30℃) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.  Do not freeze.

MATERIALS REQUIRED BUT NOT PROVIDED

Specimen collection container and timer

TEST PROCEDURE

1. SAMPLE COLLECTION AND HANDLING

To perform this test, collect a urine sample in a clean and dry container. Fresh urine does not require any special handing or pretreatment. Testing should be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 3 days or frozen at -20℃ for a longer period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature, and mixed thoroughly prior to testing.

2. TO CARRY OUT THE TEST

Sample well   Test line    Control line

DIRECTIONS FOR USE

• The test is formulated for use with fresh urine specimens. Wear gloves and use the urine cup to collect urine.
• Remove the test cassette from its foil pouch.
• Draw urine sample into dropper, and dispense it into the sample well on the cassette (2-3 drops, approximately 100μl). Be careful not to overfill the absorbent pad.
• Read results in 5 minutes.
• Discard the test device after a single use.

Please Wait the full 5 minutes to confirm the result. Do not read the one step FSH Test after 5 minutes as this may give an incorrect test result.

This is a single use test. Please safely dispose of the strip, regard this as infectious material and dispose of the test appropriately after use.

3. HOW TO READ THE RESULT

Positive: Two pink/purple bands form, and the color of the test band is equal to or more intense than that of the control/reference band.

Negative: One pink/purple band forms in the control region; no band is found in the test region, or the color of the test band is less intense than that of the control/reference band.                                                                                                                                                                                                 

Invalid: If there is no pink/purple band in the control region, the test result is invalid. Retest the sample using a new device.

WARNING&PRECAUTIONS

For in vitro diagnostic use only

1. As with all diagnostic tests, a definitive diagnostic should not be based on the results of a single test, but should only be made by the physician after all clinical and lab findings have been evaluated.

2.Read directions for use carefully before performing this test. Pay attention to the position of the C and T line .

3. Do not use beyond the labeled expiry date.
4. Do not reuse the test devices. Discard it in the dustbin after single use.
5. Do not use if pouch is damaged or opened.
6. Do not touch the membrane located within the window.
7. Once open the pouch, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.
8. Treat urine samples and used devices as if they are potentially infectious. Avoid contact with skin
9. Examine if the urine dropper and urine cup exists before usage.

BIBLIOGRAPHY

1. "Chinese Medical Association of the Eighth National Conference on Medical examination face" , "Test the perimenopausal women’s urine of FSH to know the clinical significance ", Jianrong Han of Tianjin People's Hospital.PU-414
2. "Northeast Agricultural University" 33 No. 3 September 2002, "Follicle Stimulating Hormone Research," Hongbin Guan , Qingzhang Li of Veterinary Medicine, Northeast Agricultural University, Harbin 150030.

3."in vitro diagnostic reagents written instructions guiding principles" SFDA [2007]No.240.

4."China Biological Products" 2002 Supplement, China Biological Standardization Committees