Division of Biostatistics, School of Public Health, The University of Minnesota at Twin Cities, Minneapolis, MN 55455, USA.
Influenza Other Respir Viruses. 2012 Mar;6(2):80-6. doi: 10.1111/j.1750-2659.2011.00284.x. Epub 2011 Aug 31.
Following the outbreaks of 2009 pandemic H1N1 infection, rapid influenza diagnostic tests have been used to detect H1N1 infection. However, no meta-analysis has been undertaken to assess the diagnostic accuracy when this manuscript was drafted.
The literature was systematically searched to identify studies that reported the performance of rapid tests. Random effects meta-analyses were conducted to summarize the overall performance.
Seventeen studies were selected with 1879 cases and 3477 non-cases. The overall sensitivity and specificity estimates of the rapid tests were 0·51 (95%CI: 0·41, 0·60) and 0·98 (95%CI: 0·94, 0·99). Studies reported heterogeneous sensitivity estimates, ranging from 0·11 to 0·88. If the prevalence was 30%, the overall positive and negative predictive values were 0·94 (95%CI: 0·85, 0·98) and 0·82 (95%CI: 0·79, 0·85). The overall specificities from different manufacturers were comparable, while there were some differences for the overall sensitivity estimates. BinaxNOW had a lower overall sensitivity of 0·39 (95%CI: 0·24, 0·57) compared with all the others (P-value <0·001), whereas QuickVue had a higher overall sensitivity of 0·57 (95%CI: 0·50, 0·63) compared with all the others (P-value = 0·005).
Rapid tests have high specificity but low sensitivity and thus limited usefulness.
2009 年大流行 H1N1 感染爆发后,快速流感诊断检测已被用于检测 H1N1 感染。然而,在本文撰写时,尚未进行评估该检测方法的诊断准确性的荟萃分析。
系统地检索文献,以确定报告快速检测性能的研究。采用随机效应荟萃分析汇总总体性能。
共选择了 17 项研究,涉及 1879 例病例和 3477 例非病例。快速检测的总体敏感性和特异性估计值分别为 0.51(95%CI:0.41,0.60)和 0.98(95%CI:0.94,0.99)。研究报告的敏感性估计值存在异质性,范围为 0.11 至 0.88。如果流行率为 30%,则总体阳性和阴性预测值分别为 0.94(95%CI:0.85,0.98)和 0.82(95%CI:0.79,0.85)。来自不同制造商的总体特异性相当,但总体敏感性估计值存在差异。BinaxNOW 的总体敏感性为 0.39(95%CI:0.24,0.57),低于所有其他检测方法(P 值<0.001),而 QuickVue 的总体敏感性为 0.57(95%CI:0.50,0.63),高于所有其他检测方法(P 值=0.005)。
快速检测具有高特异性但敏感性低,因此实用性有限。