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

Tate JE, Mijatovic-Rustempasic S, Tam KI, Lyde FC, Payne DC, Szilagyi P, Edwards K, Staat MA, Weinberg GA, Hall CB, Chappell J, McNeal M, Gentsch JR, Bowen MD, Parashar UD
Emerg Infect Dis. 2013 19 (8): 1245-52

PMID: 23876518 · PMCID: PMC3739503 · DOI:10.3201/eid1908.130461

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.

MeSH Terms (14)

Acute Disease Case-Control Studies Child, Preschool Enzyme-Linked Immunosorbent Assay Gastroenteritis Humans Infant Molecular Diagnostic Techniques Real-Time Polymerase Chain Reaction Rotavirus Rotavirus Infections Rotavirus Vaccines Vaccination Vaccine Potency

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