Home Pregnancy Test

A home pregnancy test is a self-diagnostic tool that allows women to quickly and easily determine if
they are pregnant. These tests measure Human chorionic gonadotrophin (hCG), a hormone that is
secreted (/knowledge/Secretion.html) in urine during pregnancy. Human chorionic gonadotrophin is
measured using a technique known as an immunoassay, which involves a complex reaction between
the hormone and various protein antibodies. When urine, containing hCG, is applied to the test strip, a
reaction occurs which causes a portion of the stick to change color thus signaling the hormone is
present and that the woman is pregnant.

Background
The presence of hCG in urine has long been a factor used by doctors to determine pregnancy. During
normal gestation, hCG level doubles approximately every two days and it can be detected in urine as
early as seven days following conception. Originally, hCG measurement was a complicated test which
had to be administered by a doctor. The test involved taking a urine sample
(/knowledge/Urinalysis.html) from the woman and injecting it into a frog or rabbit; the animal was
subsequently dissected and examined. If the woman was pregnant, interactions between hCG in her
urine and the animal's reproductive system could be observed. The cliche "the rabbit died" is actually
a reference to this type of biological assay. Such testing has been replaced by immunoassay testing
techniques, which are more sensitive and easier to administer. An immunoassay is a type of test that
measures protein molecules, which interact with the pregnancy hormone in blood or urine. Early
immunoassays were done with blood because this type of test is the most sensitive and can detect
minute quantities of hCG. A positive test can be obtained within days of conception and before a
missed period. However, tests done with blood still require the involvement of a doctor or nurse.
Further improvements in immunoassay techniques led to the development of a urine-based test, which
is simple and fool-proof enough for virtually anyone to self-administer at home. In home test kits, a
protein called a monoclonal antibody (/knowledge/Monoclonal_antibodies.html) (MAb) reacts with any
hCG present in the urine. This reaction causes a color change if the level of hCG is consistent with
known pregnancy levels. This kind of test can be positive two weeks after conception or several days
after a missed menstrual period. To administer the test, a woman applies urine to a latex-coated test
strip, which has been treated with different antibodies. The anti-bodies (/knowledge/Antibody.html) are
placed in three distinct zones or bands along the test strip. The first band contains two types of
antibodies: "anti-a" hCG antibody, which will combine with any hCG in the urine, and Immunoglobin G
(or IgG), which is a control to determine that the test strip is working properly. When the urine flows
past this first antibody band, two things happen. The hCG in the urine reacts with the "anti-a" hCG
antibody and forms a complex. At the same time the urine suspends the IgG and carries both the IgG
and the urinef'anti-a" antibody complex along the strip to the second antibody band. The second band

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contains anti-b hCG antibody which reacts further with the hCG to create a chemical "sandwich" which
turns a bright color. As a result, a colored line appears in the test window of the strip. If hCG is absent, no
binding takes place and no colored line is formed. In either case, the IgG from the first antibody band
continues to move along the test strip until it contacts the third antibody band. This band contains an
antibody, which will react with the IgG, forming another colored line under the control window. If two
colored lines appear (one in the test window and one in the control), the result is positive and the user is
pregnant. If only one line appears (in the control window), the result is negative. If no line appears in the
control window, the test was not conducted proerly and should be repeated with a fresh test strip.
By the mid-1990s, this immunoassay technique had been commercialized in over two dozen retail
products. According to the October 1994 issue of Pharmacy Times, the home pregnancy test
market had grown to nearly $200 million in sales per year. Major brands include EPT, Advance,
ClearBlue Easy, and Answer Plus.

Design
The test kits on the market differ primarily by the way the user must collect and process the urine. One
type of kit requires the user to urinate directly onto an absorbent area of the test kit by holding onto one
end of the stick and urinating on the other. The urine is absorbed by the pad on the end of the test stick
and travels along the test strip by capillary action. This design is used in products like Advance,
Confirm, Clear Blue Easy, Answer, and EPT. The other type of test requires the woman to collect urine
in a separate vessel. She then utilizes a dropper to deliver a precise amount of urine into a well on the
test unit. Products using this design include Fact Plus, Precise, and Be Sure. Some brands, like Q Test
and Answer Plus, require the woman to mix the urine with other test components before adding it to the
test strip.

Components
A typical home pregnancy test contains the following components:

Immunoassay strip
The immunoassay strip is formed by compressing nonwoven fibers into a narrow strip and coating them
with reactive antibodies. The antibodies combine with the pregnancy hormone in a series of steps,
ultimately resulting in a color change.

Absorbent pad
The direct application type of test contains an absorbent pad that extends from the test chamber and is
used to contact the urine stream. The pad absorbs the liquid and draws it into contact with the
immunoassay strip.

Plastic housing
The test strip and absorbent pad are contained within a two piece housing that allows the unit to be
handheld and protects the strip from environmental contaminants. A leak-proof, clear plastic window on
the side of the housing prevents urine from accidentally splashing on the test strip and allows the test
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and control zone portions of the strip to be viewed.

Urine collection cup/vials and reagents