Abstract
We evaluated quantitative real-time PCR to establish the diagnosis of rotavirus gastroenteritis in a high-disease-burden population in Malawi using enzyme immunoassay as the gold standard diagnostic test. In 146 children with acute gastroenteritis and 65 asymptomatic children, we defined a cutoff point in the threshold cycle value (26.7) that predicts rotavirus-attributable gastroenteritis in this population. These data will inform the evaluation of direct and indirect rotavirus vaccine effects in Africa.
Highlights
Rotavirus gastroenteritis is a major cause of infant morbidity and mortality with 90% of rotavirus-associated deaths occurring in low-income settings [1,2,3]
A positive relationship between fecal viral load and EIA-positive rotavirus disease has been demonstrated in children from the United Kingdom and the United States [7, 11] and has been used to define a quantitative cycle threshold (CT) cutoff point in qRT-PCR corresponding to clinical disease [7, 11]
Receiver operating characteristics (ROC) analysis was used to evaluate the ability of qRT-PCR CT values to discriminate between the presence and absence of symptomatic gastroenteritis, using EIA as a gold standard [17, 18] and defining the absence of disease as EIA negative without diarrhea
Summary
Rotavirus gastroenteritis is a major cause of infant morbidity and mortality with 90% of rotavirus-associated deaths occurring in low-income settings [1,2,3]. As qRTPCR can detect rotavirus shedding in the stool in up to 30% of asymptomatic young children in developed settings, the clinical implications of a positive result is uncertain [9, 10].
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