Rapid differentiation of respiratory pathogens remains one of the key challenges in clinical diagnostics. Because SARS-CoV-2, influenza viruses, and respiratory syncytial virus (RSV) often present with similar symptoms, accurate pathogen identification plays an important role in clinical decision-making, infection control, and public health surveillance.
A recent peer-reviewed study published in Diagnostics evaluated the performance of the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay during the 2024–2025 respiratory virus season in France. Conducted by researchers from Hôpital Européen Georges Pompidou and Université Paris Cité, the study assessed the assay within a verification framework aligned with EN ISO 15189:2022 standards for medical laboratories.
Using 301 respiratory specimens, investigators evaluated the assay against established molecular reference methods.
The study reported:
- 94.8% sensitivity for SARS-CoV-2
- 95.8% sensitivity for Influenza A/B
- 95.2% sensitivity for RSV
- 99.2%–100.0% specificity across all targets
The study also demonstrated:
- Almost perfect agreement with reference molecular assays (Cohen’s κ: 0.939–0.974)
- Repeatability ranging from 2.34% to 4.49%
- Reproducibility ranging from 2.78% to 5.71%
For healthcare professionals, the ability to distinguish respiratory pathogens in a single test may help simplify diagnostic workflows and support clinical decision-making during respiratory virus seasons.
Designed to simplify molecular testing workflows, the VitaSIRO solo™ platform integrates nucleic acid extraction, amplification, and detection within a self-contained microfluidic cartridge. The assay is designed to simultaneously detect and differentiate SARS-CoV-2, Influenza A, Influenza B, and RSV in a single test, providing results in approximately 40 minutes with minimal hands-on time.
Beyond analytical performance, the study also highlighted the platform’s usability.
The study highlighted that the VitaSIRO solo™ Instrument demonstrated:
- Favorable usability
- User satisfaction comparable to established molecular POCT platforms
The study concluded that the VitaSIRO solo™ Instrument demonstrated favorable usability, high analytical precision, and robust performance. The authors further noted that the platform represents a reliable point-of-care solution for the rapid detection and differentiation of respiratory viruses in both hospital and decentralized testing environments.
Reference
Mboumba Bouassa, R.-S.; Lukumbisa, S.; Bélec, L. Simultaneous Detection and Differentiation of SARS-CoV-2, Influenza A/B, and Respiratory Syncytial Viruses in Respiratory Specimens Using the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay. Diagnostics 2025, 15, 2249.
VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay
Catalog No.
PCRAD1102/PCRAD1112
Technology
Real-Time PCR + Fluorescence Spectrum Detection
Quantity
12 cartridge/box
Targets
SARS-CoV-2, Flu A/B, RSV A, RSV B
Specimen
Nasal Swab + Nasopharyngeal Swab
Hands-on Time
< 1 minute
Turnaround Time
40 mins
Kit Storage
4~30°C
