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RT-PCR-based assessment of the SD Bioline Rota/Adeno Antigen-based test in infants with and without diarrhea
Gédéon Prince Manouana1,2, Paul Alvyn Nguema-Moure3, Alexandru Tomazatos4
1Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. manouanacermel@gmail.com.
Insights
This study evaluated rapid rotavirus tests (RDT) against RT-qPCR in Gabon. The RDT showed high specificity and suitability for detecting rotavirus A gastroenteritis in children, making it a valuable tool for low-income settings.
Area of Science:
- Virology
- Pediatrics
- Infectious Diseases
Background:
- Rotavirus A (RVA) is a leading cause of severe diarrhea in children globally.
- Rapid diagnostic tests (RDTs) are commonly used for RVA detection, but their accuracy is questioned.
- Evaluating RDT performance against gold-standard methods is crucial for accurate diagnosis.
Purpose of the Study:
- To assess the diagnostic performance of a rapid rotavirus test (RDT) compared to one-step RT-qPCR.
- To determine the sensitivity and specificity of the RDT for detecting Rotavirus A infections.
- To evaluate the RDT's utility in a real-world clinical setting, particularly in resource-limited areas.
Main Methods:
- A cross-sectional study was conducted in Lambaréné, Gabon (April 2018 - November 2019).
- Stool samples were collected from children under 5 with diarrhea and asymptomatic controls.
- Samples were analyzed using SD BIOLINE Rota/Adeno Ag RDT and compared with one-step RT-qPCR.
Main Results:
- The RDT demonstrated an overall sensitivity of 46.46% and specificity of 96.64% compared to RT-qPCR.
- A 91% concordance was observed between the RDT and RT-qPCR for detecting RVA gastroenteritis.
- RDT performance varied with seasonality, symptoms, and RVA genotype.
Conclusions:
- The RDT is a suitable tool for detecting Rotavirus A gastroenteritis with high specificity.
- While the RDT is effective, RT-qPCR identified some asymptomatic RVA shedding missed by the RDT.
- The RDT is a potentially valuable diagnostic tool, especially in low-income countries for managing childhood diarrhea.
Background:
Rotavirus A (RVA) infections remain a major cause of severe acute diarrhea affecting children worldwide. To date, rapid diagnostic tests (RDT) are widely used to detect RVA. However, paediatricians question whether the RDT can still detect the virus accurately. Therefore, this study aimed to evaluate the performance of the rapid rotavirus test in comparison to the one-step RT-qPCR method.
Methods:
A cross-sectional study was conducted in Lambaréné, Gabon, from April 2018 to November 2019. Stool samples were collected from children under 5 years of age with diarrhoea or a history of diarrhoea within the last 24 h, and from asymptomatic children from the same communities. All stool samples were processed and analysed using the SD BIOLINE Rota/Adeno Ag RDT against a quantitative reverse transcription PCR (RT-qPCR), which is considered the gold standard.
Results:
For a total of 218 collected stool samples, the overall sensitivity of the RDT was 46.46% (confidence interval (CI) 36.38-56.77), with a specificity of 96.64% (CI 91.62-99.08) compared to one-step RT-qPCR. After confirming the presence or absence of RVA gastroenteritis, the RDT showed suitable results in detecting rotavirus A-associated disease, with a 91% concordance with the RT-qPCR. Furthermore, the performance of this test varied when correlated with seasonality, symptoms, and rotavirus genotype.
Conclusion:
This RDT showed high sensitivity and was suitable for the detection of RVA in patients with RVA gastroenteritis, although some asymptomatic RVA shedding was missed by RT-qPCR. It could be a useful diagnostic tool, especially in low-income countries.
