SUMMARY
Follicle Stimulating Hormone 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 indicating
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 child bearing stage of life, the
ovaries gradually make less of the hormone estrogen and
FSH increases. FSH normally regulates the growth and
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. Health risks that can come
with menopause usually include osteoporosis, increased
blood cholesterol and increased risk of heart disease. 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, therefore, be performed twice to
help identify the levels of FSH throughout a menstrual
cycle.
The FSH Test is a one step assay for the rapid qualitative
determination of FSH in the urine. The immunological
specificity of the test kit virtually eliminates cross reactivity
and interference to structurally related glycoprotein
hormones such as hLH, hCG and hTSH.
PRINCIPLE
The FSH Test is a qualitative, two-site sandwich immunoassay
for the determination of human follicle stimulating
hormone(FSH) in urine. The membrane was pre-coated
with FSH specific antibodies on the test region. During the
test, the urine 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
regents in the test region and produces a colored band
that is equal to or more intensive than that of control band
when FSH concentration is equal to or greater than 25
miu/ml. If the color intensity of the test band is less than
that of control band, it suggests a negative result. To serve
as a procedural control, a colored band at control region
will always apprear regardless the presence of FSH.
REAGENTS
Each FSH Test strip individually sealed in a foil pouch.
Ingredients: Test device containing test strip with capture
anti-hFSH antibody coated membrane and colored
anti-hFSH antibody pad.
