聚合酶链反应比色斑点印迹法及临床预测试验概率用于痰涂片阴性患者肺结核的诊断

PCR colorimetric dot-blot assay and clinical pretest probability for diagnosis of Pulmonary Tuberculosis in smear-negative patients.

作者信息

Scherer Luciene Cardoso, Sperhacke Rosa Dea, Jarczewski Carla, Cafrune Patrícia I, Minghelli Simone, Ribeiro Marta Osório, Mello Fernanda Cq, Ruffino-Netto Antonio, Rossetti Maria Lr, Kritski Afrânio L

机构信息

Programa de pós Graduação em Ciências Biológicas- Bioquímica, Universidade Federal do Rio Grande do Sul-UFRGS, Porto Alegre, RS, Brazil.

出版信息

BMC Public Health. 2007 Dec 20;7:356. doi: 10.1186/1471-2458-7-356.

DOI:10.1186/1471-2458-7-356

PMID:18096069

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2241618/

Abstract

BACKGROUND

Smear-negative pulmonary tuberculosis (SNPTB) accounts for 30% of Pulmonary Tuberculosis (PTB) cases reported annually in developing nations. Polymerase chain reaction (PCR) may provide an alternative for the rapid detection of Mycobacterium tuberculosis (MTB); however little data are available regarding the clinical utility of PCR in SNPTB, in a setting with a high burden of TB/HIV co-infection.

METHODS

To evaluate the performance of the PCR dot-blot in parallel with pretest probability (Clinical Suspicion) in patients suspected of having SNPTB, a prospective study of 213 individuals with clinical and radiological suspicion of SNPTB was carried out from May 2003 to May 2004, in a TB/HIV reference hospital. Respiratory specialists estimated the pretest probability of active disease into high, intermediate, low categories. Expectorated sputum was examined by direct microscopy (Ziehl-Neelsen staining), culture (Lowenstein Jensen) and PCR dot-blot. Gold standard was based on culture positivity combined with the clinical definition of PTB.

RESULTS

In smear-negative and HIV subjects, active PTB was diagnosed in 28.4% (43/151) and 42.2% (19/45), respectively. In the high, intermediate and low pretest probability categories active PTB was diagnosed in 67.4% (31/46), 24% (6/25), 7.5% (6/80), respectively. PCR had sensitivity of 65% (CI 95%: 50%-78%) and specificity of 83% (CI 95%: 75%-89%). There was no difference in the sensitivity of PCR in relation to HIV status. PCR sensitivity and specificity among non-previously TB treated and those treated in the past were, respectively: 69%, 43%, 85% and 80%. The high pretest probability, when used as a diagnostic test, had sensitivity of 72% (CI 95%:57%-84%) and specificity of 86% (CI 95%:78%-92%). Using the PCR dot-blot in parallel with high pretest probability as a diagnostic test, sensitivity, specificity, positive and negative predictive values were: 90%, 71%, 75%, and 88%, respectively. Among non-previously TB treated and HIV subjects, this approach had sensitivity, specificity, positive and negative predictive values of 91%, 79%, 81%, 90%, and 90%, 65%, 72%, 88%, respectively.

CONCLUSION

PCR dot-blot associated with a high clinical suspicion may provide an important contribution to the diagnosis of SNPTB mainly in patients that have not been previously treated attended at a TB/HIV reference hospital.

摘要

背景

在发展中国家，涂片阴性肺结核（SNPTB）占每年报告的肺结核（PTB）病例的30%。聚合酶链反应（PCR）可能为快速检测结核分枝杆菌（MTB）提供一种替代方法；然而，在结核/艾滋病病毒合并感染负担较高的情况下，关于PCR在SNPTB中的临床效用的数据很少。

方法

为了评估PCR斑点印迹法与疑似SNPTB患者的检测前概率（临床怀疑）的并行性能，2003年5月至2004年5月在一家结核/艾滋病病毒参考医院对213例临床和影像学疑似SNPTB的个体进行了一项前瞻性研究。呼吸专科医生将活动性疾病的检测前概率估计为高、中、低三类。对咳出的痰液进行直接显微镜检查（萋-尼染色）、培养（罗氏培养基）和PCR斑点印迹法检测。金标准基于培养阳性结合PTB的临床定义。

结果

在涂片阴性且未感染艾滋病病毒的受试者中，活动性PTB的诊断率分别为28.4%（43/151）和42.2%（19/45）。在检测前概率高、中、低三类中，活动性PTB的诊断率分别为67.4%（31/46）、24%（6/25）、7.5%（6/80）。PCR的敏感性为65%（95%可信区间：50%-78%），特异性为83%（95%可信区间：75%-89%）。PCR的敏感性与艾滋病病毒感染状况无关。在既往未接受过结核病治疗的患者和既往接受过治疗的患者中，PCR的敏感性和特异性分别为：69%、43%、85%和80%。高检测前概率用作诊断试验时，敏感性为72%（95%可信区间：57%-84%），特异性为86%（95%可信区间：78%-92%）。将PCR斑点印迹法与高检测前概率并行用作诊断试验时，敏感性、特异性、阳性和阴性预测值分别为：90%、71%、75%和88%。在既往未接受过结核病治疗且感染艾滋病病毒的受试者中，这种方法的敏感性、特异性、阳性和阴性预测值分别为91%、79%、81%、90%，以及90%、65%、72%、88%。