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Publications

Journal Article Preprint Epublish

PubMed: 39606339 DOI: 10.1101/2024.11.16.24317422

Bias in control selection associated with the use of rapid tests in influenza vaccine effectiveness studies.

medRxiv

Authors: Eero Poukka, Caitriona Murphy, Loretta Mak, Samuel M S Cheng, Malik Peiris, Tim K Tsang, Sheena G Sullivan, Benjamin J Cowling

Affiliations

  • Department of Public Health, Finnish Institute for Health and Welfare (THL), Mannerheimintie 166, 00300, Helsinki, Finland.
  • Department of Public Health, Faculty of Medicine, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.
  • World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam Hong Kong Special Administrative Region, China.
  • World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam Hong Kong Special Administrative Region, China. Centre for Immunology and Infection, Hong Kong Science and Technology Park, New Territories, Hong Kong Special Administrative Region, China.
  • Laboratory of Data Discovery for Health Limited, Hong Kong Science and Technology Park, New Territories, Hong Kong Special Administrative Region, China.
  • School of Clinical Sciences, Monash University, Melbourne, Australia.
  • Department of Epidemiology, University of California, Los Angeles, USA.

Abstract

In test-negative design studies that use rapid tests to estimate influenza vaccine effectiveness (VE) a common concern is case/control misclassification due to imperfect test sensitivity and specificity. However, an imperfect test can also fail to exclude from the control group people that do not represent the source population, including people infected with other influenza types or other vaccine-preventable respiratory viruses for which vaccination status is correlated. We investigated these biases by comparing the effectiveness of seasonal 2023/24 influenza vaccination against influenza A and B based on PCR versus rapid test results, excluding controls who tested positive for SARS-CoV-2 or the other type of influenza. By PCR, VE against influenza A was 49% (95%CI 26-65%) after exclusion of PCR-confirmed influenza B and SARS-CoV-2 controls. Corresponding VE against influenza B was 65% (95%CI 35-81%). VE estimated by adjusting for COVID-19 vaccination status yielded similar estimates to the scenario that excluded SARS-CoV-2-positive controls. When case/control status and exclusions from test-negative controls were determined by rapid test, VE was reduced by 5-15 percentage points. Bias correction methods were able to reduce these discrepancies. When estimating VE from a test-negative study using rapid test results, methods to correct misclassification bias are recommended.

MeSH

Bias, Vaccines, Vaccination, Influenza, Human, Influenza Vaccines