IHRC Inc., contracting agency to the Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
PLoS One. 2018 Apr 13;13(4):e0195979. doi: 10.1371/journal.pone.0195979. eCollection 2018.
The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests.
Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2-4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods-pertussis culture as the "gold standard," composite reference standard analysis (CRS), and latent class analysis (LCA).
Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough.
Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis.
准确使用临床诊断检测对于检测百日咳至关重要，百日咳是一种控制不佳的疫苗可预防疾病。本研究的目的是估计包括培养、多靶聚合酶链反应（PCR）、抗百日咳毒素 IgG（IgG-PT）血清学和使用临床病例定义在内的不同诊断标准的敏感性和特异性。另一个目的是描述各种测试的最佳标本采集时间。
2007 年至 2011 年期间，在美国七个地点从患有咳嗽疾病的患者中采集临床标本。在登记就诊时，从每位患者采集鼻咽和血液标本。对于咳嗽时间≤2 周的患者，要求他们在 2-4 周内返回采集第二份恢复期血液标本。使用三种方法-百日咳培养作为“金标准”、综合参考标准分析（CRS）和潜在类别分析（LCA）来估计每种诊断测试的敏感性和特异性。
总体而言，共有 868 名患者入组，至少有一项诊断检测结果呈 B. pertussis 阳性的患者占 13.6%。在 545 名所有四项诊断标准均无缺失数据的参与者样本中，培养的敏感性为 64.0%，PCR 的敏感性为 90.6%，通过 LCA 两者均为 100%特异性。CRS 和 LCA 方法比基于培养的估计增加了恢复期血清学和临床病例定义的敏感性估计值。培养和 PCR 在咳嗽的前两周进行时最敏感；在咳嗽的第二周后，血清学检测最敏感。
在为百日咳订购诊断检测时，应考虑与疾病发作相关的标本采集时间。应考虑将 IgG-PT 血清学作为州和地区流行病学家理事会（CSTE）百日咳病例定义的确认检测。
