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Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children.

Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children.
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Schnee SV, Pfeil J, Ihling CM, Tabatabai J, Schnitzler P,


Schnee SV, Pfeil J, Ihling CM, Tabatabai J, Schnitzler P, (click to view)

Schnee SV, Pfeil J, Ihling CM, Tabatabai J, Schnitzler P,

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BMC infectious diseases 2017 12 1317(1) 767 doi 10.1186/s12879-017-2855-1

Abstract
BACKGROUND
Respiratory syncytial virus (RSV) is the most important cause of severe acute respiratory tract infection in young children. Alere i RSV is a novel molecular rapid test which identifies respiratory syncytial virus in less than 13 min.

METHODS
We evaluated the clinical performance of the Alere i RSV assay in a pediatric point-of-care setting during winter season 2016 / 2017. Test results from 518 nasopharyngeal swab samples were compared to a real-time reverse transcription PCR reference standard.

RESULTS
The overall sensitivity and specificity of the Alere i RSV test assay was 93% (CI95 89% – 96%) and 96% (CI95 93% – 98%), respectively. Alere i RSV performed well in children of all age groups. An optimal sensitivity of 98% (CI95 94% – 100%) and specificity of 96% (CI95 90% – 99%) was obtained in children < 6 months. In children ≥ 2 years, sensitivity and specificity remained at 87% (CI95 73% - 96%) and 98% (CI95 92% - 100%), respectively. False negative Alere i RSV test results mostly occurred in samples with low viral load (mean CT value 31.1; CI95 29.6 - 32.6). The Alere i RSV assay is easy to use and can be operated after minimal initial training. Test results are available within 13 min, with most RSV positive samples being identified after approximately 5 min. CONCLUSION
The Alere i RSV assay has the potential to facilitate the detection of RSV in pediatric point-of-care settings.

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