From McGill University, McGill University Health Centre, and Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada, and Royal College of Surgeons in Ireland, Dublin, Ireland.
Ann Intern Med. 2017 Sep 19;167(6):394-409. doi: 10.7326/M17-0848. Epub 2017 Sep 5.
Rapid and accurate influenza diagnostics can improve patient care.
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.
6 databases from their inception through May 2017.
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 were extracted using a standardized form; quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) criteria.
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.
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.
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.
Québec Health Research Fund and BD Diagnostic Systems.
快速准确的流感诊断可以改善患者的治疗效果。
总结和比较传统的快速流感诊断检测（RIDTs）、数字免疫测定（DIAs）和快速核酸扩增检测（NAATs）在疑似流感的儿童和成人中的准确性。
从建立到 2017 年 5 月的 6 个数据库。
以英语、法语或西班牙语发表的比较商业化快速检测（即在 30 分钟内提供结果）与流感诊断的逆转录聚合酶链反应参考标准的研究。
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。
纳入 162 项研究（RIDTs 130 项，DIAs 19 项，NAATs 13 项）。基于贝叶斯二变量随机效应模型的流感 A 检测的汇总敏感性为 RIDTs 54.4%（95%可信区间[CrI]，48.9%至 59.8%），DIAs 80.0%（CrI，73.4%至 85.6%），NAATs 91.6%（CrI，84.9%至 95.9%）。检测流感 B 的汇总敏感性为 RIDTs 53.2%（CrI，41.7%至 64.4%），DIAs 76.8%（CrI，65.4%至 85.4%），NAATs 95.4%（CrI，87.3%至 98.7%）。汇总特异性均较高（>98%）。46 项流感 A 和 24 项流感 B 研究提供了儿科特异性数据；35 项流感 A 和 16 项流感 B 研究提供了成人特异性数据。除快速 NAATs 检测的流感 A 外（2.7 个百分点），儿童的汇总敏感性高出 12.1 至 31.8 个百分点。以产业赞助的研究为参照，汇总敏感性高 6.2 至 34.0 个百分点。不完整的报告常常导致偏倚风险不明确。
临床变量报告不足，限制了异质性的探索。很少有 NAAT 研究报告了成人特异性数据，也没有研究评估即时检测。许多研究的偏倚风险不明确。
新型 DIAs 和快速 NAATs 对儿童和成人的流感 A 和 B 的敏感性明显高于传统 RIDTs，特异性同样较高。
魁北克卫生研究基金和 BD 诊断系统。
