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Influenza Other Respir Viruses. 2012 Mar;6(2):80-6. doi: 10.1111/j.1750-2659.2011.00284.x. Epub 2011 Aug 31.

Performance of rapid influenza H1N1 diagnostic tests: a meta-analysis.

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Division of Biostatistics, School of Public Health, The University of Minnesota at Twin Cities, Minneapolis, MN 55455, USA.



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.

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