Performance characteristics of the polymerase chain reaction assay to confirm clinical meningococcal disease
Performance characteristics of the polymerase chain reaction assay to confirm clinical meningococcal disease
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DOI：
10.1136/adc.83.3.271
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发表时间：
2000-09-01
影响因子：
5.2
通讯作者：
Hart, CA
中科院分区：
文献类型：
--
作者：
Carrol, ED;Thomson, APJ;Hart, CA
背景-临床脑膜炎球菌病（MCD）的确认对于患者、接触者和暴发的管理至关重要。血液和脑脊液培养，传统的金标准诊断测试，已受到入院前注射青霉素和腰椎穿刺较少的不利影响。无需培养分离株即可快速、可靠地进行血清群测定，可以改善MCD的实验室确认。目的-确定当前可用的脑膜炎球菌聚合酶链反应（PCR）检测试剂盒在临床环境中的性能特征。方法-对319名疑似诊断为MCD的儿童进行前瞻性研究结果-共有166名（占全部的52%）儿童患有临床MCD：其中119名（72%）经微生物学确诊。性能特性对确诊MCD的敏感性、特异性、阴性预测值、阳性预测值分别为（95%置信区间）：血培养31%（24-38%）、100%、57%（49-65%）、100%;血PCR 47%（39-55%）、100%、65%（58-73%）、100%;任何试验阳性率分别为72%（65-79%）、100%、77%（70-84%）、100%。结论PCR法检测血液或脑脊液中脑膜炎球菌DNA是诊断MCD的有效方法。外周血PCR检测结果优于血培养。对于临床怀疑患有MCD的儿童，除了血液或CSF培养外，还应进行PCR检测、细菌抗原检测和口咽拭子脑膜炎球菌携带，以提高病例确诊率。
Background-Confirmation of clinical meningococcal disease (MCD) is essential for management of patients, contacts, and outbreaks. Blood and CSF cultures, the traditional gold standard diagnostic tests, have been adversely affected by preadmission parenteral penicillin and fewer lumbar punctures. Rapid, reliable serogroup determination without the need to grow isolates could improve laboratory confirmation of MCD.Aims-To determine performance characteristics of the currently available meningococcal polymerase chain reaction (PCR) assays in a clinical setting.Methods-Prospective study of 319 children presenting with a suspected diagnosis of MCD (fever and a rash, or suspected bacterial meningitis) over a 16 month period.Results-A total of 166 (52% of all) children had clinical MCD: diagnosis was confirmed microbiologically in 119 (72%) of these. Performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value) in confirmation of clinical MCD were respectively (95% confidence interval): blood culture 31% (24-38%), 100%, 57% (49-65%), 100%; blood PCR 47% (39-55%), 100%, 65% (58-73%), 100%; any test positive 72% (65-79%), 100%, 77% (70-84%), 100%.Conclusions-Meningococcal DNA detection in blood or CSF by PCR is a useful method of diagnosis of MCD. PCR of peripheral blood performs better than blood culture. In a child with clinically suspected MCD, PCR assays, bacterial antigen tests, and oropharyngeal swabbing for meningococcal carriage should be performed in addition to blood or CSF culture, to improve case confirmation.