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酶免疫分析法快速检测尿孕二醇葡萄糖醛酸苷在不孕症诊疗中的应用及预测价值

Utility and predictive value of a rapid measurement of urinary pregnanediol glucuronide by enzyme immunoassay in an infertility practice.

作者信息

Sauer M V, Paulson R J

机构信息

Department of Obstetrics and Gynecology, University of Southern California, Los Angeles.

出版信息

Fertil Steril. 1991 Nov;56(5):823-6. doi: 10.1016/s0015-0282(16)54649-4.

DOI:10.1016/s0015-0282(16)54649-4
PMID:1936313
Abstract

STUDY OBJECTIVE

To assess the clinical utility of measuring urinary pregnanediol glucuronide in random samples in an infertility practice.

DESIGN

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).

SETTING

All patients were randomly sampled.

PATIENTS

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

OUTCOME MEASURES

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.

摘要

研究目的

评估在不孕症诊疗中检测随机样本中尿孕二醇葡萄糖醛酸苷的临床实用性。

设计

在患者距上次月经约3周时收集尿液样本,以确定是否发生排卵。在分析孕二醇葡萄糖醛酸苷之前,先对每个样本进行比重检测。同时进行静脉穿刺,以将尿液检测结果与血清孕酮(P)的定量检测结果进行比较。

设置

所有患者均为随机抽样。

患者

选择390名接受醋酸亮丙瑞林垂体降调节的女性进行研究,因为她们通常在记录排卵后开始用药。

观察指标

与血清测量值2.5 ng/mL和10.0 ng/mL相比,评估尿孕二醇葡萄糖醛酸苷检测的敏感性、特异性、预测价值和检测效率。

结果

孕二醇葡萄糖醛酸苷检测的性能特征与样本采集时患者的水合状态直接相关。无论尿比重如何,如果定性检测到孕二醇葡萄糖醛酸苷(大于3微克/毫升),血清P大于2.5 ng/mL。然而,在未检测到孕二醇葡萄糖醛酸苷的情况下(小于3微克/毫升),只有当比重大于或等于1.020时结果才准确。当将尿孕二醇葡萄糖醛酸苷值与大于10 ng/mL的血清值进行比较时,由于假阳性结果数量增加,阳性检测的特异性和预测价值均降低。

结论

孕二醇葡萄糖醛酸苷的酶免疫测定法可替代血清P用于记录许多患者的排卵状态。然而,所有标本都必须检查比重,如果小于1.020,则应使用血清P以确保准确性。

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