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

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


Background: 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.

Methods: 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.

Results: 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).

Conclusions: Rapid tests have high specificity but low sensitivity and thus limited usefulness.

Publication types

  • Evaluation Study
  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Diagnostic Tests, Routine / methods*
  • Humans
  • Influenza A Virus, H1N1 Subtype / isolation & purification*
  • Influenza, Human / diagnosis*
  • Influenza, Human / virology
  • Sensitivity and Specificity
  • Virology / methods*