Diagnosing rupture of membranes using combination monoclonal/polyclonal immunologic protein detection.
Diagnosing rupture of membranes using combination monoclonal/polyclonal immunologic protein detection.
复制标题
使用组合单克隆/多克隆免疫蛋白检测诊断膜破裂。
DOI：
--
复制
发表时间：
2013
期刊：
影响因子：
--
通讯作者：
A. Neubert
中科院分区：
文献类型：
--
作者：
Tovah Thomasino;C. Levi;M. Draper;A. Neubert
目的
比较一种新的单克隆/多克隆免疫测定组合床旁检测与当前常规临床评估诊断羊膜破裂的准确性。
研究设计
这是一项在出现羊膜破裂体征或症状的患者中进行的多中心前瞻性观察性研究。本临床试验包括美国的3家研究中心。初步评价包括胎膜破裂（ROM）的标准临床评估（液体汇集、羊齿和硝嗪试验的窥器检查），以及使用新的联合免疫测定试验（包含单克隆/多克隆抗体组合方法）检测胎盘蛋白12（PP 12）和甲胎蛋白（AFP）。如果观察到液体从宫颈口渗漏，或如果存在3种情况中的2种：液体汇集、阳性硝嗪试验或羊齿，则诊断为ROM。在分娩后审查病历时确认了ROM。
结果
在285例患者（15-42周妊娠）中，新联合免疫测定试验的假阳性率为9%，假阴性率为0.5%，灵敏度为99%，特异性为91%，阳性和阴性预测值分别为95%和99%。常规临床评估的敏感性为85%，特异性为98%，阳性预测值为99%，阴性预测值为77%。Ferning的敏感性为99%，特异性为72%，阳性和阴性预测值分别为80%和99%。硝氮试验的敏感性为93%，特异性为83%，阳性预测值为90%，阴性预测值为88%。
结论
这种检测PP 12和AFP的单克隆和多克隆免疫检测组合具有与常规检测相当的功效，并且优于常规检测的单个组分（蕨类植物，硝嗪），是一种快速且易于使用的检测，可以由更广泛的护理提供者进行，并且可以改善疑似ROM患者的分流和管理。
OBJECTIVE
To compare the accuracy of a new combination monoclonal/polyclonal immunoassay point-of-care test with that of current conventional clinical assessment for diagnosis of ruptured amniotic membranes.
STUDY DESIGN
This was a multicenter prospective observational study performed in patients presenting with signs or symptoms of ruptured amniotic membranes. This clinical trial included 3 sites in the United States. Initial evaluation included both the standard clinical assessment for rupture of membranes (ROM) (speculum examination for fluid pooling, ferning, and nitrazine test), as well as the use of a new combination immunoassay test containing a combination monoclonal/polyclonal antibody approach to detect placental protein 12 (PP12) and alpha-fetoprotein (AFP). ROM was diagnosed if fluid was seen leaking from the cervical os, or if 2 of the 3 conditions were present: pooling of fluid, positive nitrazine test, or ferning. ROM was confirmed on review of the medical records following delivery.
RESULTS
Of the 285 patients (15-42 weeks of gestation), the false positive rate for the new combination immunoassay test was 9% and the false negative rate was 0.5%, sensitivity 99%, specificity 91%, positive and negative predictive values of 95% and 99%, respectively. The conventional clinical evaluation's sensitivity was 85%, specificity 98%, with positive and negative predictive values of 99% and 77%. Ferning's sensitivity was 99%, specificity 72%, with positive and negative predictive values of 80% and 99%. Nitrazine testing's sensitivity was 93%, specificity 83%, with positive and negative predictive values of 90% and 88%.
CONCLUSION
This combination monoclonal and polyclonal immunoassay test that detects PP12 and AFP has an efficacy comparable to conventional testing and better than the individual components of conventional testing (ferning, nitrazine), is a quick and easy-to-use test that can be performed by a wider variety of care providers, and can improve triage and management of patients suspected of ROM.