Special Precautions/Comments:

N.B. This test is not validated for use on urine samples received in boric acid containers.

Interferences:  Very dilute urine specimens may not contain representative levels of hCG and thus give false negative results.

False positive results can occur in conditions such as tumours and hydatidiform mole.

False positive or false negative results could occur in specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy.

Method:  Rapid chromatographic immunoassay for the qualitative detection of Human chorionic gonadotrophin (hCG) in urine to aid in the early detection of pregnancy. Calibration: N/A.  EQA scheme: NEQAS. IQC: Third-party control (Quantimetrix Dropper Plus).

Interpretation: Results will be reported as POSITIVE, WEAK POSITIVE, or NEGATIVE. Samples resulted as Weak Positive will request a repeat sample (early morning urine or serum) to be taken 48 hours after the initial sample.

As with all diagnostic tests, a definite clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical laboratory findings have been evaluated. If pregnancy is suspected, tests with negative results should be repeated after several days unless menstruation occurs.

Additional Information:

Background information: hCG is not normally detected in the urine of healthy men and non-pregnant women.  hCG can be detected in the urine of pregnant women about one week after implantation of the fertilised ovum in the uterine wall.  The concentration continues to increase during the next nine weeks reaching a maximum of 100,000-200,000 IU hCG/l at the end of the first trimester. hCG levels can remain low in ectopic pregnancies, and if this condition is suspected a serum hCG level should be performed (Biochemistry test).

Keywords: Pregnancy, hCG, urine, ectopic