INTENDED USE Follicle Stimulating Hormone(FSH) Test Strip 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. SUMMARY AND EXPLANATION Follicle Stimulating Hormone(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. Follicle-stimulating hormone is a glycoprotein hormone, molecular weight of about 30KD, glycoprotein hormone family belongs. 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 10 minutes, levels of FSH as low as 25mlU/ml can be detected. PRINCIPLE The Follicle Stimulating Hormone(FSH) assay is a rapid one-step test based on immunochromatographic technology. A membrane with an absorbent pad over a strip of fiber glass paper is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies to FSH. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the FSH antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti- FSH monoclonal antibodies affixed on the test zone ("T") will bind the FSH -gold conjugate complex, forming a pink line ("T"). Any sample will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of FSH as low as 25mIU/ml can be detected. CONTENTS, STORAGE AND STABILITY Each pouch contains: 1Step FSH Test strip and 1 Desiccant. The test kit can be stored at room temperature (39F- 86F; 4ºC-30ºC) 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, Timer
PRECAUTIONS
FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal use.
Read directions for use carefully before performing this test. Perform each step exactly as described.
Do not use beyond the expiration date marked on the foil pouch.
Each one step Follicle Stimulating Hormone(FSH) Test can only be used once; do not re-use the one step Follicle Stimulating Hormone(FSH) Test.
Do not use the Test if the foil pouch is damaged.
Once the foil pouch has been opened, the Test should be used immediately.
Discard each one step Follicle Stimulating Hormone(FSH) Test after use. Treat urine samples and used test devices as if they were potentially infectious. Avoid contact with skin.
KEEP OUT OF REACH OF CHILDREN.
TEST PROCEDURE
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 2-8ºC for 3 days or frozen at -20ºC 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.
TO CARRY OUT THE TEST
Absorbent cotton Test line Control line DIRECTIONS FOR USE
Bring the sealed pouch to room temperature.
Remove the strip from the foil pouch.
Immerse the strip into the urine with the arrow end pointing toward the urine cup. Do not cover the urine over the MAX (maximum) line.
Take the strip out of the cup after a minimum of 15 seconds and lay it flatly on a non-absorptive, clean surface.
Read the result in 10 minutes.
Discard the test device after a single use.
Please Wait the full 10 minutes to confirm the result. Do not read the one step FSH Test after 10 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 strip. Invalid Test Results can be caused by:
The absorbent tip not being wetted thoroughly.
Reading the test result too early or too late. A 10 minutes reaction time is required.
For further information, see LIMITATIONS OF THE PROCEDURE.
QUALITY CONTROL
Built in Quality Control Features: The appearance of a line in the control area indicates that the one step Follicle Stimulating Hormone(FSH) Test is performing properly and serves as a procedural control. It is recommended that a positive FSH control (containing more than 25mIU/mL FSH) and a negative FSH control (containing 0mIU/mL FSH) are evaluated to verify proper test performance when a new shipment of tests is received. LIMITATION OF THE PROCEDURE If urine sample is too dilute (ie: low specific gravity) it may not contain a representative level of FSH. We should collect a urine sample again and retest it with another strip test. As is true with any diagnostic procedure, the user should evaluate data obtained by the use of this kit with consideration to other clinical information and consult their doctor for the final diagnosis of pregnancy before making any decision of medical relevance. BIBLIOGRAPHY 1 "in vitro diagnostic reagents written instructions guiding principles" SFDA [2007]No.240. 2 "China Biological Products" 2002 Supplement, China Biological Standardization Committees.
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