Evaluation of a urinary test as a diagnostic tool of a nonprogressive pregnancy.
OBJECTIVE
To evaluate the performance of a one-step test detecting intact hCG and free β-hCG isoforms in the urine of pregnant women to diagnose an abnormal pregnancy.


METHODS
Prospective study.


METHODS
Emergency gynecology departments in teaching hospitals.


METHODS
Five hundred twenty-six patients were enrolled, 272 who were not pregnant and 254 who were pregnant.


METHODS
Semiquantitative determination of intact urinary hCG of supposedly not pregnant and pregnant women with vaginal bleeding and/or vaginal pain between 5 and 8 weeks of amenorrhea.


RESULTS
The sensitivity and specificity of the urine test for diagnosing nonpregnancy were, respectively, 100% (252/252) and 100% (272/272). The sensitivity and specificity of the urine test for diagnosing ectopic pregnancy (EP) were, respectively, 97% (32/33) and 83% (142/171). The negative predictive value is 99.3% (142/143). The sensitivity and specificity or the urine test for diagnosing miscarriage were, respectively, 89.6% (43/48) and 83% (142/171). The negative predictive value is 96.6% (142/147).


CONCLUSIONS
Abnormal pregnancy, such as an EP or a miscarriage, can be rapidly detected with the one-step test for intact hCG and free β-hCG isoforms. If ultrasound cannot confirm the localization and/or evolution of a pregnancy, using this test reduces medical supervision and repeated quantification of hCG.
Mazouz
Silhem
S
Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Clamart, France.
Lee
Jae Kwan
JK
Fernandez
Hervé
H
D000022:Abortion, Spontaneous / Q000175:diagnosis / Q000652:urine*; D000328:Adult; D003944:Diagnostic Techniques, Obstetrical and Gynecological; D020964:Embryo Loss / Q000175:diagnosis / Q000652:urine; D005260:Female; D047109:Fetal Development / Q000502:physiology; D006801:Humans; D011247:Pregnancy; D011258:Pregnancy Tests; D011261:Pregnancy Trimester, First / Q000652:urine; D011271:Pregnancy, Ectopic / Q000175:diagnosis / Q000652:urine*; D012680:Sensitivity and Specificity; D016482:Urinalysis / Q000295:instrumentation / Q000379:methods*; D055815:Young Adult