Comparison of 2 assays for diagnosing rotavirus and evaluating vaccine effectiveness in children with gastroenteritis

Emerg Infect Dis. 2013 Aug;19(8):1245-52. doi: 10.3201/eid1908.130461.

Abstract

We compared rotavirus detection rates in children with acute gastroenteritis (AGE) and in healthy controls using enzyme immunoassays (EIAs) and semiquantitative real-time reverse transcription PCR (qRT-PCR). We calculated rotavirus vaccine effectiveness using different laboratory-based case definitions to determine which best identified the proportion of disease that was vaccine preventable. Of 648 AGE patients, 158 (24%) were EIA positive, and 157 were also qRT-PCR positive. An additional 65 (10%) were qRT-PCR positive but EIA negative. Of 500 healthy controls, 1 was EIA positive and 24 (5%) were qRT-PCR positive. Rotavirus vaccine was highly effective (84% [95% CI 71%-91%]) in EIA-positive children but offered no significant protection (14% [95% CI -105% to 64%]) in EIA-negative children for whom virus was detected by qRT-PCR alone. Children with rotavirus detected by qRT-PCR but not by EIA were not protected by vaccination, suggesting that rotavirus detected by qRT-PCR alone might not be causally associated with AGE in all patients.

Keywords: RT-PCR; acute gastroenteritis; children; diagnosis; enzyme immunoassay; rotavirus; viruses.

Publication types

  • Comparative Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acute Disease
  • Case-Control Studies
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay
  • Gastroenteritis / diagnosis*
  • Gastroenteritis / prevention & control
  • Gastroenteritis / virology
  • Humans
  • Infant
  • Molecular Diagnostic Techniques
  • Real-Time Polymerase Chain Reaction
  • Rotavirus / genetics*
  • Rotavirus / immunology
  • Rotavirus Infections / diagnosis*
  • Rotavirus Infections / prevention & control
  • Rotavirus Infections / virology
  • Rotavirus Vaccines / immunology
  • Vaccination
  • Vaccine Potency

Substances

  • Rotavirus Vaccines