Related Experiment Video
Updated: Aug 8, 2026
An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Evaluation of respiratory syncytial virus (RSV) direct antigen detection assays for use in point-of-care testing
G P Leonardi1, A M Wilson1, M Dauz1
1Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, 2201 Hempstead Turnpike, Box, 47, East Meadow, NY 11554, United States.
Insights
Rapid point-of-care (POC) testing for respiratory syncytial virus (RSV) is crucial for infants. The Sofia assay demonstrated superior sensitivity and objectivity, making it a valuable choice for POC diagnostics.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Diagnostic Assays
Background:
- Respiratory syncytial virus (RSV) causes significant lower respiratory tract infections in infants and toddlers.
- Increased physician visits, emergency department use, and hospitalizations are linked to RSV outbreaks.
- Point-of-care (POC) testing offers cost reduction and aids treatment decisions but requires high sensitivity, ease of use, and rapid results.
Purpose of the Study:
- To prospectively evaluate the sensitivity and specificity of four direct antigen detection assays for RSV POC testing.
- To compare the performance of these assays against RT-PCR and fluorescent antibody testing.
- To identify optimal POC assays for rapid RSV diagnosis in clinical settings.
Main Methods:
- Prospective study of 230 nasopharyngeal specimens from patients.
- Evaluation of four direct antigen detection assays: Directigen, Quickvue, Sofia, and Veritor.
- Comparison with RT-PCR, RSV dilution studies for sensitivity, and RSV fluorescent antibody testing.
Main Results:
- Assay sensitivity: Sofia (85%), Veritor (72.5%), Directigen (70%), Quickvue (57.5%). Specificity ranged from 97-100% for all assays.
- Sofia's enhanced sensitivity may be due to fluorescent result interpretation.
- Fluorescent antibody testing showed 64% sensitivity compared to RT-PCR.
Conclusions:
- The Sofia assay is a valuable POC option due to objective results, walk-away capability, and high sensitivity.
- The Veritor assay's sensitivity may also be acceptable for POC use.
- Directigen and Quickvue assays showed limitations in objectivity and sensitivity, potentially impacting their diagnostic value.
Abstract:
RSV infections cause lower respiratory tract infections and result in surges in physician's office, emergency department visits and hospitalizations, especially in infants and toddlers. Point-of-care (POC) testing reduces healthcare costs and permits informed decisions on treatment, however, optimal POC assays must be sensitive, easy to perform and provide rapid results. A prospective study tested 230 patient nasopharyngeal specimens using 4 RSV direct antigen detection assays (Directigen, Quickvue, Sofia and Veritor) and RT-PCR. A RSV dilution study was also performed to evaluate sensitivity. RSV fluorescent antibody testing in 46/230 patients was also evaluated. Sensitivity values obtained for the Sofia, Veritor, Directigen and Quickvue assays (%) were 85, 72.5, 70 and 57.5, respectively. Fluorescent result interpretation may account for Sofia's enhanced sensitivity. Specificity (%) was 97-100 among assays. Sensitivity data were confirmed in the dilution studies. Fluorescent antibody testing demonstrated 64% sensitivity compared with RT-PCR. Objective result reporting, walk away testing and high sensitivity make the Sofia a valuable choice for POC testing. Veritor's sensitivity may also render it acceptable in POC. Lack of objective results by Directigen and the poor sensitivity observed by Quickvue may preclude their value in diagnostic testing.
