Tech Info New Brochure A/W
28/2/03
11:55 am
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Unipath Ltd, Bedford MK44 3UP, UK.
Clearblue, Unipath and the Unipath Research Logo are Registered Trademarks.
Technical Information
Most
effective
home
ovulation
test kit
28/2/03
11:55 am
Page 3
Ovulation
Ovulation is the process of an egg being
released from one of the two ovaries
in the female reproductive tract. This
process is under the control of a number
of hormones. These hormones ensure
Hormone Concentration
Tech Info New Brochure A/W
Ovulation
LH Peak
Estrogen Rise
that an egg is released from the
13 14
12
15
Day of
Ovulation
ovaries at the time in the cycle when
the uterus is ready for implantation,
Clearblue Ovulation Test –
How does the Clearblue
Technical Information
Ovulation Test work?
Unipath, the manufacturer of the
The Clearblue Ovulation Test is a fast
Clearblue Ovulation Test, pioneered
and easy to use method of detecting
the rapid immunoassay technology
the LH surge in urine. By comparing
that revolutionised home testing with
the blue lines in the test stick window,
the development of the first ever,
women can identify when their LH surge
one-step pregnancy test, Clearblue,
occurs. This provides women with:
and the first ever one step ovulation
• Clear results in just 3 minutes
• Easy to read single window to make
Detecting the Most Fertile Days
test, Clearplan. From its leading edge
Research has shown that it is possible
research facilities in Bedford, the
Knowing when you are going to ovulate
for a woman to conceive during 6 days
Research and Development team have
helps to time intercourse to increase
of her cycle and this is known as the
improved the Clearplan One step
the chances of getting pregnant. The
Fertile Period (1). However, she is more
Ovulation test, with the development
Clearblue® Ovulation Test helps women
likely to conceive on just 2 of these
of the Clearblue Ovulation Test.
to pinpoint the most fertile days in their
days, known as the Peak Fertile Period.
cycle by testing for a sudden increase
The Peak Fertile Period is the day
Clinical research has shown that the
Because Clearblue Ovulation Test
in Luteinising Hormone (LH).
before ovulation and the day of
surge in luteinising hormone (LH)
provides women with seven test sticks,
ovulation itself.
preceded ovulation by 24-36 hours .
it is the Most Effective Ovulation Test,
In practice the LH surge was found to
increasing the chances of detecting
should fertilisation take place.
During each cycle a follicle develops in
(2)
be a better predicator of ovulation
the LH surge. As most women do not
•
than peak LH levels (3).
have 28 day cycles, the additional test
egg is sufficiently developed, a surge
of LH from the pituitary gland prompts
the release of the egg from the ovary
– ‘ovulation’. Ovulation usually occurs
within 24-36 hours of the LH surge.
The empty follicle remains in the
variable, but is typically 3- 5 days.
Sperm survival is dependent on the
type and quantity of the mucus
within the cervix, and the quality of
the sperm itself.
ovary and is known as the corpus
This was supported by ultrasound studies
more likely, than the five sticks offered
of follicle rupture which confirmed that
by other tests.
the LH surge detected in urine occurs
approximatley 24-36 hours before
The Clearblue Ovulation Test is a rapid
ovulation (4,5). This was consistent with
‘sandwich’ assay where an absorbent
the detection of LH surge in blood (4,5).
sampler collects urine directly from the
urine stream. The LH molecule is bound
LH is rapidly excreted into urine, and
by two antibodies specific for LH. One
luteum. The corpus luteum continues
Predicting when ovulation might occur
simultaneous serum and urine samples
antibody is attached to blue latex
to release progesterone and estrogen.
is critical for those women actively
obtained on the day of the LH surge
particles and the other antibody is
trying to conceive. The Clearblue
support this (2). Therefore, in individuals
immobilised in the test stick strip, in a
Ovulation generally occurs between
Ovulation Test helps women to
with normal renal function levels of
line within the test stick window (2a).
the 11th and 17th day of the menstrual
pinpoint the two most fertile days in
LH in urine rapidly reflect those in
The two antibodies bind to a different
cycle. However this can vary from one
their cycle.
peripheral blood as measured by
part of the LH molecule, so they can
radioimmunoassay (6,7). (see table below)
attach in sequence and form a
woman to another, and from one cycle
Reference line
2a Positive test – start
Urine
LH in urine flows
through the test
2b Positive test – finish
Blue latex particle bound
to anti-β LH antibody
Blue latex particle bound
to anti-β LH antibody
anti-α LH antibody
anti-control antibody
Result window
Surge line
sticks make detecting the LH surge
to to 24 hours after ovulation.
• The lifespan of sperm which is more
Surge line
the LH surge
The fertile period is affected by:
detected in blood and urine. When the
Absorbent
sampler
• A test they can use at any time of day
• 99% accurate* at detecting
egg. As it develops the cells in the
follicle secrete estrogen, which can be
1
comparing lines easier
the ovary, which contains the developing
The lifespan of the egg, which is up
How the Clearblue Ovulation Test Works
3
Reference line
Negative test
Urine
anti-control antibody
Result window
Reference line
Clearblue Ovulation Test –
surge has been detected, and this
Clinical Support
spontaneous or induced ovulation,
indicates that conception is most
There have been many publications
Unipath’s ovulation test detected
likely if intercourse occurs during the
supporting the use of Unipath’s ovulation
the LH surge an average of 2 days
next 1-2 days.
test kit, both at home and in the clinic.
in advance of the basal body
to another. The average length of the
‘sandwich’. Increasing amounts of LH
menstrual cycle is 28 days, but this can
cause the blue ‘surge’ line to become
• In a laboratory study of 235 menstrual
vary from woman to woman and
most women have cycles between 23
Serum
and 35 days.
Urine
*Based on laboratory testing of
urine samples.
Basal Level
Peak Level
stronger (2b). A reference line will form
cycles Unipath’s ovulation test kit
5-26mlU/ml
25-200mlU/ml
when the test is run correctly, even if
accurately determined the LH surge
there is no LH in the urine (3). If the
in 99% of cycles when compared
LH surge line is similar to or darker
to radioimmunoassay (7).
6-13mlU/ml
50-200mlU/ml
References:
1. Wilcox A.J., Weinberg C.R., Baird D.D.
Timing of sexual intercourse in relation
to ovulation. N. Engl. J. Med. 333,
1517-21, 1995
2. World Health Organisation. Fertil Steril
1983; 39:647-654
3. Corsan GH, Ghazi D, Kemmann E.
Fertil Steril 1990; 53: 591-601
• In a study of 82 patients with
than the reference line then the LH
4. Bourne TH, Hagstom H-G, Hawin M,
Bosetsean B, Granby S, Harinbergoh L,
Collins WP. Fertil and Steril 1996; 65:
753-758
5. Miller PB, Soules MR. Obstet Gynecol
1996; 87: 13-17
6. Collins WP, Branch CM, Collins PO,
Sallam HN. Int J Fertil 1981; 26: 196-202
temperature change (BBT) and 3
days in advance of detectable
ultrasound changes. Clomiphene
citrate induction did not affect the
reliability of the test (8).
7. Testart J, Frydman R. Fertil Steril 1982;
37: 50-53
8. Pungetti D, Mastrantoni M, Ecari U,
Lenzi M. Contraccezione Fertilita
Sessualita: 1994; 21: 2-11