Accurate Point-of-Care Detection of Ruptured Fetal Membranes: Improved Diagnostic Performance Characteristics with a Monoclonal/Polyclonal Immunoassay.

Clinical Medicine Insights-Reproductive Health Pub Date : 2016-05-09 eCollection Date: 2016-01-01 DOI:10.4137/CMRH.S38386

Linda C Rogers, Laurie Scott, Jon E Block

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引用次数: 12

Abstract

Objective: Accurate and timely diagnosis of rupture of membranes (ROM) is imperative to allow for gestational age-specific interventions. This study compared the diagnostic performance characteristics between two methods used for the detection of ROM as measured in the same patient.

Methods: Vaginal secretions were evaluated using the conventional fern test as well as a point-of-care monoclonal/polyclonal immunoassay test (ROM Plus(®)) in 75 pregnant patients who presented to labor and delivery with complaints of leaking amniotic fluid. Both tests were compared to analytical confirmation of ROM using three external laboratory tests. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy.

Results: Diagnostic performance characteristics uniformly favored ROM detection using the immunoassay test compared to the fern test: sensitivity (100% vs. 77.8%), specificity (94.8% vs. 79.3%), PPV (75% vs. 36.8%), NPV (100% vs. 95.8%), and accuracy (95.5% vs. 79.1%).

Conclusions: The point-of-care immunoassay test provides improved diagnostic accuracy for the detection of ROM compared to fern testing. It has the potential of improving patient management decisions, thereby minimizing serious complications and perinatal morbidity.

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准确的点护理检测胎儿膜破裂:单克隆/多克隆免疫分析改进诊断性能特征。

目的:准确和及时诊断胎膜破裂(ROM)是必要的，允许孕龄特异性干预。本研究比较了在同一患者中用于检测ROM的两种方法之间的诊断性能特征。方法:对75例以羊水泄漏为主诉分娩的孕妇进行阴道分泌物评估，采用常规羊水检测和即时单克隆/多克隆免疫测定(ROM Plus(®))。将这两项测试与使用三个外部实验室测试的ROM分析确认进行比较。计算诊断性能特征，包括敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)和准确性。结果:与蕨类植物试验相比，免疫分析试验的诊断性能特征一致倾向于ROM检测:灵敏度(100%对77.8%)、特异性(94.8%对79.3%)、PPV(75%对36.8%)、NPV(100%对95.8%)和准确性(95.5%对79.1%)。结论:与蕨类植物试验相比，即时免疫分析试验提高了ROM检测的诊断准确性。它具有改善患者管理决策的潜力，从而最大限度地减少严重并发症和围产期发病率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Medicine Insights-Reproductive Health OBSTETRICS & GYNECOLOGY-

自引率

0.00%

发文量

审稿时长

8 weeks

期刊介绍： Clinical Medicine Insights: Reproductive Health is a peer reviewed; open access journal, which covers all aspects of Reproduction: Gynecology, Obstetrics, and Infertility, spanning both male and female issues, from the physical to the psychological and the social, including: sex, contraception, pregnancy, childbirth, and related topics such as social and emotional impacts. It welcomes original research and review articles from across the health sciences. Clinical subjects include fertility and sterility, infertility and assisted reproduction, IVF, fertility preservation despite gonadotoxic chemo- and/or radiotherapy, pregnancy problems, PPD, infections and disease, surgery, diagnosis, menopause, HRT, pelvic floor problems, reproductive cancers and environmental impacts on reproduction, although this list is by no means exhaustive Subjects covered include, but are not limited to: • fertility and sterility, • infertility and ART, • ART/IVF, • fertility preservation despite gonadotoxic chemo- and/or radiotherapy, • pregnancy problems, • Postpartum depression • Infections and disease, • Gyn/Ob surgery, • diagnosis, • Contraception • Premenstrual tension • Gynecologic Oncology • reproductive cancers • environmental impacts on reproduction, • Obstetrics/Gynaecology • Women''s Health • menopause, • HRT, • pelvic floor problems, • Paediatric and adolescent gynaecology • PID