Utility and predictive value of a rapid measurement of urinary pregnanediol glucuronide by enzyme immunoassay in an infertility practice.
OBJECTIVE
To assess the clinical utility of measuring urinary pregnanediol glucuronide in random samples in an infertility practice.


METHODS
Samples of urine were collected from patients approximately 3 weeks from their last menstrual period to ascertain if ovulation had occurred. Each sample was tested for specific gravity before analyzing for pregnanediol glucuronide. Simultaneous venipuncture was performed to compare results from the urinary assay to quantitative measures of serum progesterone (P).


METHODS
All patients were randomly sampled.


METHODS
Three hundred ninety women undergoing pituitary down regulation with leuprolide acetate were chosen for study because they routinely initiate medication after documentation of ovulation.


METHODS
The performance of the urinary pregnanediol glucuronide was evaluated as to its sensitivity, specificity, predictive value, and test efficiency compared with a serum measurement of 2.5 ng/mL and 10.0 ng/mL.


RESULTS
The performance characteristics of the pregnanediol glucuronide assay were directly related to the hydration status of the patient at the time of sample collection. Regardless of urine specific gravity, if pregnanediol glucuronide was qualitatively detected (greater than 3 micrograms/mL), serum P was greater than 2.5 ng/mL. However, in cases in which pregnanediol glucuronide was undetected (less than 3 micrograms/mL), results were only accurate when the specific gravity was greater than or equal to 1.020. When comparing urinary pregnanediol glucuronide values to serum greater than 10 ng/mL, both specificity and predictive value of a positive test decreased because of increased numbers of false-positive results.


CONCLUSIONS
The enzyme immunoassay measurement for pregnanediol glucuronide may replace the use of serum P in documenting the ovulatory status of many patients. However, all specimens must be checked for specific gravity and if less than 1.020, a serum P should be used to ensure accuracy.
Sauer
M V
MV
Department of Obstetrics and Gynecology, University of Southern California, Los Angeles.
Paulson
R J
RJ
D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D007247:Infertility, Female / Q000628:therapy / Q000652:urine*; D010061:Ovulation Detection / Q000379:methods; D011237:Predictive Value of Tests; D011276:Pregnanediol / Q000031:analogs & derivatives* / Q000652:urine; D011374:Progesterone / Q000097:blood; D012680:Sensitivity and Specificity; D013046:Specific Gravity; D014556:Urine / Q000737:chemistry
C022270:pregnanediol-3 alpha-glucuronide; D011374:Progesterone; D011276:Pregnanediol