title: Comparison of 2 assays for diagnosing rotavirus and evaluating vaccine effectiveness in children with gastroenteritis.
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.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. jqt8@cdc.gov
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Tate
authors.forename: Slavica
authors.initials: S
authors.lastname: Mijatovic-Rustempasic
authors.forename: Ka Ian
authors.initials: KI
authors.lastname: Tam
authors.forename: Freda C
authors.initials: FC
authors.lastname: Lyde
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Payne
authors.forename: Peter
authors.initials: P
authors.lastname: Szilagyi
authors.forename: Kathryn
authors.initials: K
authors.lastname: Edwards
authors.forename: Mary Allen
authors.initials: MA
authors.lastname: Staat
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Weinberg
authors.forename: Caroline B
authors.initials: CB
authors.lastname: Hall
authors.forename: James
authors.initials: J
authors.lastname: Chappell
authors.forename: Monica
authors.initials: M
authors.lastname: McNeal
authors.forename: Jon R
authors.initials: JR
authors.lastname: Gentsch
authors.forename: Michael D
authors.initials: MD
authors.lastname: Bowen
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
mesh_terms: D000208:Acute Disease; D016022:Case-Control Studies; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005759:Gastroenteritis / Q000175:diagnosis* / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007223:Infant; D025202:Molecular Diagnostic Techniques; D060888:Real-Time Polymerase Chain Reaction; D012401:Rotavirus / Q000235:genetics* / Q000276:immunology; D012400:Rotavirus Infections / Q000175:diagnosis* / Q000517:prevention & control / Q000821:virology; D022243:Rotavirus Vaccines / Q000276:immunology; D014611:Vaccination; D064166:Vaccine Potency
chemical_list: D022243:Rotavirus Vaccines
keywords: RT-PCR; acute gastroenteritis; children; diagnosis; enzyme immunoassay; rotavirus; viruses