Elsevier

The Journal of Pediatrics

Volume 163, Issue 3, September 2013, Pages 911-913
The Journal of Pediatrics

Clinical and Laboratory Observation
Host and Viral Factors Affecting Clinical Performance of a Rapid Diagnostic Test for Respiratory Syncytial Virus in Hospitalized Children

Portions of this study were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 10, 2012.
https://doi.org/10.1016/j.jpeds.2013.03.067Get rights and content

Respiratory syncytial virus rapid antigen detection tests (RADT) are used widely. RADT exhibited high specificity (97%) and moderate sensitivity (80%) compared with reverse-transcriptase polymerase chain reaction in 720 hospitalized children <3 years old. Older age, prolonged symptoms, and respiratory syncytial virus genotype-B infection were significantly associated with false-negative results of RADT.

Section snippets

Methods

Children aged 0-35 months hospitalized for acute RTI at the pediatric reference center in Quebec City (population: 747 000), Canada, were enrolled prospectively during 4 consecutive winters (November to April, 2006-2010) following Research Ethics Board approval.9 Clinical data were collected by interview at study entry and after 1-month follow-up; medical records were also reviewed. A nasopharyngeal aspirate was collected at presentation. The specimen was stored at 4°C and tested within 18

Results

Diagnostic test results were available for the RADT and reference standard in 720 of 734 children (98.1%). Mean (±SD) and median patient ages were 8.8 (±8.5) and 5.7 months, respectively.

Annual RSV positivity ranged from 60% to 69% over the four winters. RADT diagnosed 370 of 463 RSV infections (sensitivity 80.0%; 95% CI, 76.0%-83.5%). Among 257 RSV-negative patients, 249 were correctly identified by RADT (specificity 96.9%; 95% CI, 94.0%-98.6%). Positive predictive value was 97.9% (95% CI,

Discussion

Because of their simplicity, speed, and performance characteristics, RSV RADTs are valuable diagnostic tools that are used extensively in clinical laboratories. In 2010-11, RADTs generated two-thirds of the results reported to a RSV surveillance program comprising >200 US diagnostic laboratories.3 Given their widespread use and their public health importance in surveillance, we assessed risk factors for a false-negative RADT result. We observed that patient age, duration of symptoms, and

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Supported by the Canadian Institutes of Health Research (151504 to G.B.) and MedImmune Inc. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. G.B. has received research funds from GlaxoSmithKline, Hoffmann La Roche, and Abbott. D.B. has received research funds from GlaxoSmithKline. G.D.S. has received research funds from GlaxoSmithKline and Sanofi-Pasteur and has participated in an ad hoc GlaxoSmithKline advisory board meeting for which travel expenses were reimbursed. The remaining author declares no conflicts of interest.

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