Accuracy and Cross-Reactivity of Rapid Diagnostic Tests for Norovirus and Rotavirus in a Real Clinical Setting
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Background: Rapid diagnostic test (RDT) of norovirus and rotavirus is commonly used for outbreak screening and patient management. Varying accuracy of the test and cross-reactivity has been reported and could affect the outcome of management. The primary purpose of this study is to provide the accuracy of norovirus and rotavirus rapid diagnostic tests and to analyze the cross-reactivity of both tests. Materials and Methods: Stool samples collected from every acute diarrhea patient aged <15 years old who was admitted at Bhumibol Adulyadej Hospital, Bangkok, Thailand, from November 2014 to September 2016 underwent the following test: QuickNaviTM – Norovirus2 for norovirus, VIKIA® Rota-Adeno for rotavirus, and aerobic bacterial culture. Real-time reverse transcription polymerase chain reaction was used as a gold standard for virus detection. False-positive results determined cross-reactivity. Results: From 358 stool specimens, the sensitivity of RDTs for norovirus and rotavirus was 27.5% and 44.8%, respectively. The specificity of RDTs for norovirus and rotavirus was 97.7% and 91.6%, respectively. False positive results of RDT for norovirus occurred in 6 samples (1.7%) and 22 samples (6.1%) in RDT for rotavirus. Rotavirus RDT was found to have crossreactivity with 11 norovirus infection and 3 bacterial infected stools. Conclusion: We found that the RDTs for both rotavirus and norovirus have high specificity but low sensitivity. Cross-reactivity was observed in positive rotavirus RDT with half of it being norovirus.
Abstract
Background: Rapid diagnostic test (RDT) of norovirus and rotavirus is commonly used for outbreak screening and patient management. Varying accuracy of the test and cross-reactivity has been reported and could affect the outcome of management. The primary purpose of this study is to provide the accuracy of norovirus and rotavirus rapid diagnostic tests and to analyze the cross-reactivity of both tests. Materials and Methods: Stool samples collected from every acute diarrhea patient aged <15 years old who was admitted at Bhumibol Adulyadej Hospital, Bangkok, Thailand, from November 2014 to September 2016 underwent the following test: QuickNaviTM – Norovirus2 for norovirus, VIKIA® Rota-Adeno for rotavirus, and aerobic bacterial culture. Real-time reverse transcription polymerase chain reaction was used as a gold standard for virus detection. False-positive results determined cross-reactivity. Results: From 358 stool specimens, the sensitivity of RDTs for norovirus and rotavirus was 27.5% and 44.8%, respectively. The specificity of RDTs for norovirus and rotavirus was 97.7% and 91.6%, respectively. False positive results of RDT for norovirus occurred in 6 samples (1.7%) and 22 samples (6.1%) in RDT for rotavirus. Rotavirus RDT was found to have crossreactivity with 11 norovirus infection and 3 bacterial infected stools. Conclusion: We found that the RDTs for both rotavirus and norovirus have high specificity but low sensitivity. Cross-reactivity was observed in positive rotavirus RDT with half of it being norovirus.
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