Summary and Explanation of the Test

PREGNANCY 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 Interpretation of Results

- Elevated levels of HCG as low as 20 IU/ml can be detected within 3 minutes.

(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