Clinical Effectiveness of Urinary Human Chorionic Gonadotropin Related Protein (hCGRP) Quantification for Diagnosis of Ectopic Pregnancy

ABSTRACT

We detected pregnancy related new molecule, human chorionic gonadotropin related protein (hCGRP) in the urine of a pregnant women by using a monoclonal antibody against the human chorionic gonadotropin (hCG). This study examined the effectiveness of urinary hCGRP quantification in diagnosing ectopic pregnancy. This study included 40 normal pregnant women and 25 patients with ectopic pregnancy. Patients' serum and urinary intact whole hCG (i-hCG) and hCGRP concentrations were measured using sandwich ELISA and the ratio of hCGRP to i-hCG was calculated. Statistical analysis was performed using statistical package for social sciences (SPSS) 10.0. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the cut-off value to discriminate ectopic pregnancies from normal intrauterine pregnancies. Urinary hCGRP and hCGRP/i-hCG ratio in ectopic pregnancy group (14 +/- 6.6 ng/mL, 4.6 +/- 1.9%, respectively) were significantly lower than those of normal pregnancy group (149 +/- 10.2 ng/mL, 29.7 +/- 1.9%, respectively; p<0.001). Based on ROC curve analysis, a cut-off point of urinary hCGRP/i-hCG ratio <16.2% discriminated between ectopic pregnancy and normal pregnancy with a sensitivity, specificity, positive predictive value and negative predictive value of 92.0%, 90.0%, 32.6%, and 99.5%, respectively. Urinary hCGRP/i-hCG ratio measurement may be effective in diagnosing ectopic pregnancy.