Commercial nucleic-acid amplification tests for diagnosis of pulmonary tuberculosis in respiratory specimens: meta-analysis and meta-regression.
Commercial nucleic-acid amplification tests for diagnosis of pulmonary tuberculosis in respiratory specimens: meta-analysis and meta-regression.
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DOI：
10.1371/journal.pone.0001536
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发表时间：
2008-02-06
期刊：
影响因子：
3.7
通讯作者：
Pai, Madhukar
中科院分区：
文献类型：
--
作者：
Ling, Daphne I.;Flores, Laura L.;Riley, Lee W.;Pai, Madhukar
数百项研究评估了核酸扩增测试（NAAT）对结核病（TB）的诊断准确性。商业检测已被证明比内部检测提供更一致的结果。以前的荟萃分析发现，高特异性，但低和高度可变的敏感性估计。然而，研究结果变异的原因尚未得到充分探讨。我们对商业NAAT诊断肺结核的准确性进行了荟萃分析，并进行了荟萃回归分析，以确定与更高准确性相关的因素。我们通过检索文献确定了2948篇引文。我们发现402篇文章符合我们的资格标准。在最终分析中，纳入了来自105篇报告呼吸道标本NAAT结果的文章的125项单独研究。合并灵敏度为0.85（范围0.36-1.00），合并特异性为0.97（范围0.54-1.00）。然而，这两种测量结果均具有显著异质性（p<0.001）。我们进行了亚组和荟萃回归分析，以确定异质性的来源。即使在按商业试验类型分层后，我们也无法解释变异性。在荟萃回归分析中，阈值效应显著（p = 0.01），使用除痰液外的其他呼吸道标本与更高的准确性相关。 呼吸道标本中商业NAAT的灵敏度和特异性估计值差异很大，灵敏度低于特异性，且不一致性更大。因此，诊断准确性的汇总指标无临床意义。使用不同的临界值和使用痰液以外的标本可以解释观察到的一些异质性。根据这些观察，不能推荐单独使用商业NAAT来取代诊断肺结核的常规测试。需要提高诊断的准确性，特别是敏感性，以便使这种昂贵的技术在低资源国家变得有价值和有益。
Hundreds of studies have evaluated the diagnostic accuracy of nucleic-acid amplification tests (NAATs) for tuberculosis (TB). Commercial tests have been shown to give more consistent results than in-house assays. Previous meta-analyses have found high specificity but low and highly variable estimates of sensitivity. However, reasons for variability in study results have not been adequately explored. We performed a meta-analysis on the accuracy of commercial NAATs to diagnose pulmonary TB and meta-regression to identify factors that are associated with higher accuracy. We identified 2948 citations from searching the literature. We found 402 articles that met our eligibility criteria. In the final analysis, 125 separate studies from 105 articles that reported NAAT results from respiratory specimens were included. The pooled sensitivity was 0.85 (range 0.36–1.00) and the pooled specificity was 0.97 (range 0.54–1.00). However, both measures were significantly heterogeneous (p<.001). We performed subgroup and meta-regression analyses to identify sources of heterogeneity. Even after stratifying by type of commercial test, we could not account for the variability. In the meta-regression, the threshold effect was significant (p = .01) and the use of other respiratory specimens besides sputum was associated with higher accuracy. The sensitivity and specificity estimates for commercial NAATs in respiratory specimens were highly variable, with sensitivity lower and more inconsistent than specificity. Thus, summary measures of diagnostic accuracy are not clinically meaningful. The use of different cut-off values and the use of specimens other than sputum could explain some of the observed heterogeneity. Based on these observations, commercial NAATs alone cannot be recommended to replace conventional tests for diagnosing pulmonary TB. Improvements in diagnostic accuracy, particularly sensitivity, need to be made in order for this expensive technology to be worthwhile and beneficial in low-resource countries.
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影响因子：
9.4
作者：
ABE, C;HIRANO, K;GOTO, S
通讯作者：
GOTO, S
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作者：
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DOI：
10.1164/ajrccm.153.5.8630609
发表时间：
1996-05-01
影响因子：
24.7
作者：
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通讯作者：
Catanzaro, A
DOI：
10.1016/s0732-8893(99)00086-3
发表时间：
1999-11-01
影响因子：
2.9
作者：
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通讯作者：
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