PREGNANCY TEST

Summary and Explanation of the Test

- There are two types of pregnancy tests; one uses a urine sample, the
other a sample of blood

- Both tests detect the presence of a hormone called human chorionic

gonadotropin (hCG).

- Human chorionic gonadotropin (HCG) is a glycopeptide hormone

produced by the placenta during pregnancy.

- The appearance and rapid increase in the concentration of HCG in the

mother's urine makes it a good marker for confirming pregnancy.

Principles of the Test

- HCG Urine Test is a chromatographic immunoassay which use
specific antibodies conjugated with dye to selectively identify and bind
HCG in urine with a high degree of sensitivity

- The antibody-dye conjugate binds to the HCG in the specimen forming

an antibody-antigen complex with color reaction
Reagents Used
Regents are for in vitro diagnostic use only.
The test kit contains combination of goat/rabbit polyclonal antibodies
and mouse monoclonal antibodies in a protein buffer containing
sodium azide.
Urine Collection and Storage
(1) First morning urine typically contains the highest concentration of
HCG and is therefore the best sample for performing the urine test.
(2) Collect the urine specimen in a clean glass or plastic container.
(3) Do not use preservatives.
(4) If the specimen is not used immediately following collection, but is to
be used within 48 hours it should be refrigerated (2 to 8 degrees C),
and brought back to room temperature (l5 to 30 degrees C) before
testing
Assay Procedure
1. Remove the test strip from its foil pouch.
2. Holding the strip vertically, carefully dip it into the specimen.
Do not immerse the strip past the maximum line
3. The strip can be left in the specimen or can be removed from the
specimen when red-dye begins to migrate through the Result Window.
Interpret test results at 3 to 5 minutes.
4. Do not interpret test results after 5 minutes.
Detection limit of pregnancy test
- Elevated levels of HCG as low as 20 IU/ml can be detected within 3
minutes.
Interpretation of Results
(1) NEGATIVE:
If there is only one purple color band in the result window, this indicates
that the specimen does not contain a detectable level of HCG and
should be interpreted as a negative result

(2) POSITIVE:
If there are two purple color bands in the result window, this indicates
that the specimen contains HCG and should be interpreted as
positive result

(3) INVALID:
If there is no purple color band in the result window, the test result is
invalid.
The control band will not appear if an insufficient volume of specimen is
added into the test kit.
Proper procedures may not have been followed in performing the test
or deterioration of the test kit may have occurred.
Repeat the test procedure
Limitations of the Procedure
1. The Urine HCG Pregnancy Test is for in vitro diagnostic use only.

2. Although the test is very accurate in detecting pregnancy a

low incidence of false results can occur.

3. As with all diagnostic tests, a definitive clinical diagnosis should

not be based on the results of a single test, but should only be
made by the physician after all clinical and laboratory findings
have been evaluated.

4. A negative result obtained from a urine specimen collected

from a mother in very early pregnancy may be due to an
extremely low concentration of HCG. In such cases, the test
should be repeated on a fresh specimen

5. Testing should NOT begin before day 12 after ovulation This is

because of low concentration of HCG before day 12