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Rotavirus, vaccine failure or diagnostic error?

Monica Lopez-Lacort1, Susana Collado2, Ana Díez-Gandía2

  • 1Vaccine Research Department of FISABIO, Valencia, Spain.

Vaccine
|October 30, 2016
PubMed
Summary
This summary is machine-generated.

Immunochromatography (ICG) tests for rotavirus (RV) in vaccinated children yield many false positives. This can inaccurately suggest vaccine failure, impacting vaccine confidence and effectiveness estimates.

Keywords:
Diagnostic errorsDiagnostic testsRotavirusRotavirus infectionRotavirus vaccinesRoutineVaccine failure

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Area of Science:

  • Clinical Diagnostics
  • Vaccinology
  • Epidemiology

Background:

  • Immunochromatography (ICG) is widely used for rotavirus (RV) diagnosis in clinical settings.
  • The specificity of ICG tests is not 100%, leading to potential false positives, especially in low-prevalence populations like vaccinated children.
  • ICG is sometimes used for vaccine effectiveness studies and surveillance, necessitating accurate test validation.

Purpose of the Study:

  • To estimate the validity of ICG tests in vaccinated children.
  • To quantify the number of false positive rotavirus antigen test results in vaccinated children in the Valencian Region, Spain.
  • To assess the impact of vaccination status, hospitalization, and seasonality on ICG test accuracy.

Main Methods:

  • Utilized population-based registries to identify RV antigen tests in children under 37 months between January 2008 and June 2012.
  • Linked databases to obtain hospitalization and vaccination status for patients.
  • Employed a Bayesian latent class model to estimate the Positive Predictive Value (PPV) of the ICG test, stratified by vaccination status, hospitalization, and rotavirus season.

Main Results:

  • Of 48,833 valid tests, 9,429 were in vaccinated children, with 42% performed during the rotavirus season.
  • Prevalence of positive results in vaccinated children ranged from 2.9% to 21.4%, depending on hospitalization and seasonality.
  • The estimated PPV varied significantly (27.1% to 84.6%). Approximately 51.3% (267/520) of positive results in vaccinated children were false positives.

Conclusions:

  • A substantial proportion of positive ICG rotavirus tests in vaccinated children are false positives.
  • Over-testing in vaccinated children, particularly outside the rotavirus season, inflates false positive rates.
  • Misinterpreting these false positives as vaccine failures can erode public confidence in rotavirus vaccines and underestimate their effectiveness.