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Updated: Mar 29, 2026
Rapid Molecular Detection and Differentiation of Influenza Viruses A and B
Published on: January 30, 2017
Evaluation of Flu A/B, SARS-CoV-2, and RSV Antigen Combo Rapid Test in Hospitalized Children Under Two Years of Age
Birhan Mulugeta1,2, Dessalegn Fentahun1, Dawit Hailu1
1Armauer Hansen Research Institute, Addis Ababa P.O. Box 1005, Ethiopia.
Insights
A new rapid diagnostic test accurately detects respiratory syncytial virus (RSV) and influenza A/B (Flu A/B) in young children. This multiplex antigen combo test offers high specificity and accuracy, crucial for timely diagnosis in pediatric hospital settings.
Area of Science:
- Pediatric Infectious Diseases
- Virology
- Diagnostic Technologies
Background:
- Respiratory viruses, including RSV and influenza, cause significant childhood hospitalizations and deaths in sub-Saharan Africa.
- Current diagnostic methods are time-consuming, necessitating rapid, multiplexed solutions.
- The study addresses the need for efficient diagnostics in pediatric respiratory illness.
Purpose of the Study:
- To evaluate the clinical performance of a novel lateral flow assay (LFA) based antigen combo rapid diagnostic test (ML Ag Combo RDT).
- The test detects respiratory syncytial virus (RSV), influenza A/B (Flu A/B), and SARS-CoV-2.
- Assessing its utility in pediatric hospital settings for respiratory infections.
Main Methods:
- A cohort of 470 nasopharyngeal swab (NPS) specimens from hospitalized children under two years old with respiratory symptoms was analyzed.
- The ML Ag Combo RDT was compared against the Allplex panel 1 real-time quantitative PCR (rRT-qPCR) assay as the reference standard.
- Clinical performance metrics including sensitivity, specificity, PPV, NPV, and agreement (kappa coefficient) were calculated.
Main Results:
- The ML Ag Combo RDT showed high sensitivity (90.06%) and specificity (98.38%) for RSV detection.
- For Flu A/B, sensitivity was 30% and specificity was 100%, with strong agreement (κ=0.90) for RSV and moderate (κ=0.45) for Flu A/B.
- The test achieved 100% sensitivity for RSV and Flu A/B in samples with high viral loads (Ct < 20).
Conclusions:
- The ML Ag Combo RDT exhibits high specificity and diagnostic accuracy for RSV and Flu A/B detection in pediatric settings.
- The test's performance is particularly strong in samples with high viral loads.
- Timely diagnosis of these critical respiratory infections in children is significantly aided by this rapid multiplex assay.
Abstract:
Background/Objectives: Next to malaria, respiratory viruses, particularly respiratory syncytial virus (RSV), are responsible for the hospitalization and death of thousands of young children each year in sub-Saharan Africa. During peak seasons, conducting separate tests is time-consuming and distressing. This underscores the need for efficient, rapid multiplexed diagnostic tools. This study aimed to evaluate the clinical performance of a lateral flow assay (LFA) based antigen combo rapid diagnostic test (ML Ag Combo RDT, manufactured by MobiLab) that detects RSV, influenza viruses A and B (Flu A/B), and SARS-CoV-2. Methods: The Allplex panel 1 rRT-qPCR assay was used as a reference assay to evaluate the clinical performance of the LFA Ag Combo RDT in pediatric hospital settings. It was performed using 470 nasopharyngeal swab (NPS) specimens from hospitalized children under two years of age with respiratory symptoms. Results: Based on the comparative analysis of the testing results for 470 NPS, the ML Ag Combo RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 90.06%, 98.38%, 93.67, and 97.39% for RSV, and 30%, 100%, 100%, and 95.43 for Flu A/B, respectively. Agreement with the Allplex panle1 1 rRT-qPCR was strong (κ = 0.90 for RSV) and moderate (κ = 0.45 for Flu A/B), with overall accuracies of 96.63% for RSV and 95.5 for Flu A/B. This was further supported by ROC analysis for aggregated data (RSV and, Flu A/B) with an AUC value of 0.925. As expected, in samples with high viral loads (Ct < 20), the Ag Combo RDT achieved 100% sensitivity for RSV and Flu A/B. Sensitivity declined slightly at lower viral loads (Ct > 35). Conclusions: The ML Ag Combo RDT demonstrates high specificity and diagnostic accuracy for the detection of RSV and Flu A/B in pediatric hospital settings where timely diagnosis is critical.
