INTENDED USE

Home Menopause Test Strip is an in vitro diagnostic (IVD) qualitative test for rapid detection of human Follicle Stimulating Hormone (FSH) in urine at a sensitivity of 25mIU/ml.

SUMMARY AND EXPLANATION OF THE TEST

Follicle Stimulating Hormone (FSH) is a peptide hormone produced in the pituitary gland of the brain. It is normally present in the blood or urine varying in concentration with the stage of the menstrual cycle. When estrogen levels drop, FSH is released from the pituitary gland indicating that either a woman in mid-menstrual cycle or the onset of perimenopause. During early menopause, changes take place in the balance of hormones that regulate and control menstrual cycles. As a woman grows older and passes out of childbearing stage of life, the ovaries gradually make less of the hormone estrogen and FSH increases. FSH normally regulates the growth and development of an egg. Once this part of the monthly cycle is complete, FSH production is stopped and it returns to normal. As the body decreases estrogen production with age, more FSH is made. Over time these hormone changes cause menstrual periods to stop completely and "menopause" has occurred. The slow change in ovary function can happen between 2 and 10 years before the final period. This early stage before menopause is called perimenopause. During this stage, the levels of FSH may rise to positive levels and slowly return to normal, causing irregular or missed periods. The testing for FSH should be performed twice to help identify the levels of FSH throughout a menstrual cycle.

PRINCIPLE

Home Menopause Test Strip is a qualitative, two site sandwich immunoassay for the determination of human follicle stimulating hormone (FSH) in urine specimens. The membrane was precoated with FSH specific antibodies on the test region. During the test, the specimen is allowed to react with the FSH monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by the capillary action. For a positive specimen, the conjugate binds to the FSH forming an antibody-antigen complex. This complex binds to the FSH antibody as a capture regent on the test region and produces a colored band when FSH concentration is equal to or greater than 25mIU/ml. The Home Menopause Test Strip also provides a built-in process control. A colored band should always appear in the Control Region, regardless of the presence of any urinary FSH. This control band verifies that 1) sufficient urine volume was added 2) proper urine flow was obtained 3) the test is functioning correctly. The absence of a control band may indicate the test was not performed correctly or that the test did not function correctly.

MATERIALS SUPPLIED

1.2 individually wrapped test in a labeled box. Each wrap contains a Home Menopause Test Strip and a desiccant.

2.One instruction insert.

MATERIALS NOT PROVIDED BUT REQUIRED

1.Urine specimen collection container, either plastic or class.

2.Timer.

SPECIMENS COLLECTION AND STORAGE

1.The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be used.

2.The urine specimens can be stored at, if not tested immediately, 2-8 °C for up to 3 days after collection.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use after expiration date.

3. Test device should remain sealed until ready for use. Do not use if pouch is damaged or opened.

4. Read this instruction carefully before performing the test.

5. Do not re-use the test device.

6. Do not eat the desiccant in the pouch.

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.

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