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Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared With Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis
Annals of Internal Medicine ( IF 19.6 ) Pub Date : 2017-09-05 , DOI: 10.7326/m17-0848
Joanna Merckx 1 , Rehab Wali 1 , Ian Schiller 1 , Chelsea Caya 1 , Genevieve C Gore 1 , Caroline Chartrand 1 , Nandini Dendukuri 1 , Jesse Papenburg 1
Affiliation  

Background:

Rapid and accurate influenza diagnostics can improve patient care.

Purpose:

To summarize and compare accuracy of traditional rapid influenza diagnostic tests (RIDTs), digital immunoassays (DIAs), and rapid nucleic acid amplification tests (NAATs) in children and adults with suspected influenza.

Data Sources:

6 databases from their inception through May 2017.

Study Selection:

Studies in English, French, or Spanish comparing commercialized rapid tests (that is, providing results in <30 minutes) with reverse transcriptase polymerase chain reaction reference standard for influenza diagnosis.

Data Extraction:

Data were extracted using a standardized form; quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) criteria.

Data Synthesis:

162 studies were included (130 of RIDTs, 19 of DIAs, and 13 of NAATs). Pooled sensitivities for detecting influenza A from Bayesian bivariate random-effects models were 54.4% (95% credible interval [CrI], 48.9% to 59.8%) for RIDTs, 80.0% (CrI, 73.4% to 85.6%) for DIAs, and 91.6% (CrI, 84.9% to 95.9%) for NAATs. Those for detecting influenza B were 53.2% (CrI, 41.7% to 64.4%) for RIDTs, 76.8% (CrI, 65.4% to 85.4%) for DIAs, and 95.4% (CrI, 87.3% to 98.7%) for NAATs. Pooled specificities were uniformly high (>98%). Forty-six influenza A and 24 influenza B studies presented pediatric-specific data; 35 influenza A and 16 influenza B studies presented adult-specific data. Pooled sensitivities were higher in children by 12.1 to 31.8 percentage points, except for influenza A by rapid NAATs (2.7 percentage points). Pooled sensitivities favored industry-sponsored studies by 6.2 to 34.0 percentage points. Incomplete reporting frequently led to unclear risk of bias.

Limitations:

Underreporting of clinical variables limited exploration of heterogeneity. Few NAAT studies reported adult-specific data, and none evaluated point-of-care testing. Many studies had unclear risk of bias.

Conclusion:

Novel DIAs and rapid NAATs had markedly higher sensitivities for influenza A and B in both children and adults than did traditional RIDTs, with equally high specificities.

Primary Funding Source:

Québec Health Research Fund and BD Diagnostic Systems.



中文翻译:

与逆转录酶聚合酶链反应相比,新型和传统流感感染快速检测的诊断准确性:系统评价和荟萃分析

背景:

快速准确的流感诊断可以改善患者护理。

目的:

总结和比较传统快速流感诊断测试 (RIDT)、数字免疫分析 (DIA) 和快速核酸扩增测试 (NAAT) 在疑似流感儿童和成人中的准确性。

数据源:

从成立到 2017 年 5 月的 6 个数据库。

研究选择:

用英语、法语或西班牙语比较商业化快速检测(即在 30 分钟内提供结果)与逆转录酶聚合酶链反应参考标准进行流感诊断的研究。

数据提取:

使用标准化表格提取数据;使用 QUADAS-2(诊断准确性研究的质量评估 2)标准评估质量。

数据合成:

纳入了 162 项研究(130 项 RIDT、19 项 DIA 和 13 项 NAAT)。从贝叶斯双变量随机效应模型中检测甲型流感的汇总敏感性为 RIDT 为 54.4%(95% 可信区间 [CrI],48.9% 至 59.8%),DIA 为 80.0%(CrI,73.4% 至 85.6%)和 91.6 NAAT 的百分比(CrI,84.9% 至 95.9%)。检测 B 型流感的 RIDT 为 53.2%(CrI,41.7% 至 64.4%),DIA 为 76.8%(CrI,65.4% 至 85.4%),NAAT 为 95.4%(CrI,87.3% 至 98.7%)。合并的特异性均较高(>98%)。46 项甲型流感和 24 项乙型流感研究提供了儿科特异性数据;35 项甲型流感和 16 项乙型流感研究提供了针对成人的数据。除了快速 NAAT 的 A 型流感(2.7 个百分点)外,儿童的汇总敏感性高 12.1 至 31.8 个百分点。汇总的敏感性有利于行业赞助的研究 6.2 至 34.0 个百分点。不完整的报告经常导致不明确的偏倚风险。

限制:

临床变量的少报限制了对异质性的探索。很少有 NAAT 研究报告了针对成人的数据,也没有一项评估床旁检测。许多研究存在不明确的偏倚风险。

结论:

新型 DIA 和快速 NAAT 在儿童和成人中对甲型和乙型流感的敏感性明显高于传统 RIDT,具有同样高的特异性。

主要资金来源:

魁北克健康研究基金和 BD 诊断系统。

更新日期:2017-09-05
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