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Summary and Explanation of the Test
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. The concentration of hCG in urine increases steadily to a circulation peak of as much as 50,000 mIU/ml between the eighth and eleventh weeks (1,2,3).
Our hCG Urine Test is a chromatographic immunoassay which use specific antibodies to selectively identify hCG in urine with a high degree of sensitivity. Elevated levels of hCG as low as 20 mIU/ml can be detected within 3 minutes.
Principles of the Pregnancy Test
Urine is added to the test kit and allowed to migrate through the absorbent device. The labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the test zone and produces a purple color band when the hCG concentration is equal to or greater than 20 mIU/ml. In the absence of hCG, no band is formed in the test zone. The reaction mixture continues flowing through the absorbent device past the test and control zones. Unbound conjugate binds to the reagents in the control zone, producing a purple color band, demonstrating that the reagents and the test kit are functioning correctly.
Pregnancy Test Kit Storage
The test kit may be stored at room temperature for up to 18 months or until the expiration date. Optional Liquid control reagent may have different storage requirements. Refer to individual components for their specific requirements.
Urine Collection and Storage
Please read these instructions fully
(1) First morning urine typically contains the highest concentration of hCG and is therefore the best sample for performing the urine test. However, any urine specimen may be used.
(2) Collect the urine specimen in a clean glass or plastic container. Do not use preservatives.
(3) 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. If specimen is not going to be used for more than 48 hours, it should be frozen at -20 degrees C. A frozen specimen should not be used if stored longer than 2 weeks. Prior to testing, the frozen specimen must be completely thawed, thoroughly mixed, and brought to room temperature.
Test 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 (Figure 1).
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. Do not interpret test results after 5 minutes.
Interpretation of Results (Figure 2)
(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 bands 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 using a new test kit.
Note: The instructions provided must be strictly followed in order to achieve optimal test reactivity with the urine specimens.
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