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

Abstract

BackgroundRespiratory 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.MethodsWe 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.ResultsThe 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.ConclusionThe Alere i RSV assay has the potential to facilitate the detection of RSV in pediatric point-of-care settings.Electronic supplementary materialThe online version of this article (10.1186/s12879-017-2855-1) contains supplementary material, which is available to authorized users.

Dielectric spectroscopy technique for detection of human respiratory syncytial virus

“…The current detection methods for RSV involve fluorescent material or plasmon, which improve immunoassay sensitivity . In the authors' previous work, europium nanoparticles were employed as the fluorescent material to develop a rapid fluorescent immunochromatographic strip test (FICT) for detection of RSV, and the FICT showed superior sensitivity, at 90%, and specificity, at 98.18%.…”

Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests

“…Before comparing test methods, including published studies, it should be emphasized that regardless of the method, test performance is highly impacted by the viral load in the specimen (9)(10)(11)(12)(13). Thus, studies that include a high proportion of samples from young children routinely report superior test performance that is not replicated when older adults comprise the majority of the subjects.…”

“…One Alere i RSV study tested pediatric patients in the POC setting (12). The sensitivity overall for RSV was 93% compared to that for rtRT-PCR, and RSV positives were available in 5 min.…”

“…The sensitivity overall for RSV was 93% compared to that for rtRT-PCR, and RSV positives were available in 5 min. However, positives with low viral loads (mean C T , 31.1) were missed (12). A second study, performed on frozen samples by laboratory personnel, reported 100% sensitivity of Alere i RSV in young children compared to that for rtRT-PCR.…”

Profile of the Alere i Influenza A & B assay: a pioneering molecular point-of-care test

“…It has the ability to report a positive result in as little as 15 minutes and provides greater convenience in reagent storage. The platform menu has been extended to include test cartridges for the detection of Group A Streptococcus (Alere i Strep A) [30,39] and respiratory syncytial virus (Alere i RSV) [40,41]. This menu expansion will continue over the next five years and beyond.…”