根据呼吸道标本类型评估结核分枝杆菌诊断微生物学检测的性能：一项 10 年回顾性研究。
Performance of microbiological tests for tuberculosis diagnostic according to the type of respiratory specimen: A 10-year retrospective study.
机构信息
Faculty of Business and Economics, University of Lausanne, Lausanne, Switzerland.
Institute of Microbiology, Lausanne University and University Hospital of Lausanne, Lausanne, Switzerland.
出版信息
Front Cell Infect Microbiol. 2023 Mar 2;13:1131241. doi: 10.3389/fcimb.2023.1131241. eCollection 2023.
BACKGROUND
The microbial diagnosis of tuberculosis (TB) remains challenging and relies on multiple microbiological tests performed on different clinical specimens. Polymerase chain reactions (PCRs), introduced in the last decades has had a significant impact on the diagnosis of TB. However, questions remain about the use of PCRs in combination with conventional tests for TB, namely microscopy and culture. We aimed to determine the performance of microscopy, culture and PCR for the diagnosis of pulmonary tuberculosis according to the type of clinical specimen in order to improve the diagnostic yield and to avoid unnecessary, time and labor-intensive tests.
METHODS
We conducted a retrospective study (2008-2018) on analysis (34'429 specimens, 14'358 patients) performed in our diagnostic laboratory located in the Lausanne University Hospital to compare the performance of microbiological tests on sputum, induced sputum, bronchial aspirate and bronchoalveolar lavage (BAL). We analysed the performance using a classical "per specimen" approach and a "per patient" approach for paired specimens collected from the same patient.
RESULTS
The overall sensitivities of microscopy, PCR and culture were 0.523 (0.489, 0.557), 0.798 (0.755, 0.836) and 0.988 (0.978, 0.994) and the specificity were 0.994 (0.993, 0.995), 1 (0.999, 1) and 1 (1, 1). Microscopy displayed no significant differences in sensitivity according to the type of sample. The sensitivities of PCR for sputum, induced sputum, bronchial aspirate and BAL were, 0.821 (0.762, 0.871), 0.643 (0.480, 0.784), 0.837 (0.748, 0.904) and 0.759 (0.624, 0.865) respectively and the sensitivity of culture were, 0.993 (0.981, 0.998), 0.980 (0.931, 0.998), 0.965 (0.919, 0.988), and 1 (0.961, 1) respectively. Pairwise comparison of specimens collected from the same patient reported a significantly higher sensitivity of PCR on bronchial aspirate over BAL (p < 0.001) and sputum (p < 0.05) and a significantly higher sensitivity of culture on bronchial aspirate over BAL (p < 0.0001).
CONCLUSIONS
PCR displayed a higher sensitivity and specificity than microscopy for all respiratory specimens, a rational for a smear-independent PCR-based approach to initiate tuberculosis microbial diagnostic. The diagnosis yield of bronchial aspirate was higher than BAL. Therefore, PCR should be systematically performed also on bronchial aspirates when available.
背景
结核病（TB）的微生物诊断仍然具有挑战性，需要对不同的临床标本进行多种微生物学检测。聚合酶链反应（PCR）在过去几十年中被引入，对 TB 的诊断产生了重大影响。然而，关于 PCR 与传统的 TB 检测（即显微镜检查和培养）联合使用的问题仍然存在。我们旨在根据临床标本的类型来确定显微镜检查、培养和 PCR 对肺结核的诊断性能，以提高诊断率并避免不必要的、耗时费力的检测。
方法
我们进行了一项回顾性研究（2008-2018 年），对我们位于洛桑大学附属医院的诊断实验室进行了分析（34429 个标本，14358 例患者），以比较痰、诱导痰、支气管抽吸物和支气管肺泡灌洗液（BAL）的微生物学检测性能。我们使用经典的“每份标本”方法和同一患者采集的配对标本的“每份患者”方法分析了性能。
结果
显微镜检查、PCR 和培养的总灵敏度分别为 0.523（0.489，0.557）、0.798（0.755，0.836）和 0.988（0.978，0.994），特异性分别为 0.994（0.993，0.995）、1（0.999，1）和 1（1，1）。显微镜检查根据样本类型无显著差异。PCR 对痰、诱导痰、支气管抽吸物和 BAL 的灵敏度分别为 0.821（0.762，0.871）、0.643（0.480，0.784）、0.837（0.748，0.904）和 0.759（0.624，0.865），培养的灵敏度分别为 0.993（0.981，0.998）、0.980（0.931，0.998）、0.965（0.919，0.988）和 1（0.961，1）。对同一患者采集的标本进行两两比较，报告称支气管抽吸物的 PCR 比 BAL 和痰的灵敏度显著更高（p<0.001），而培养的支气管抽吸物比 BAL 的灵敏度显著更高（p<0.0001）。
结论
PCR 对所有呼吸道标本的灵敏度和特异性均高于显微镜检查，这为基于涂片的非依赖 PCR 方法开启了结核病微生物诊断的合理途径。支气管抽吸物的诊断效果优于 BAL。因此，当有条件时，应系统地对支气管抽吸物进行 PCR 检测。
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