Evaluation of Alere i RSV for Rapid Detection of Respiratory Syncytial Virus in Children Hospitalized with Acute Respiratory Tract Infection

Peters, Rebecca Marie; Schnee, Sarah Valerie; Tabatabai, Julia; Schnitzler, Paul; Pfeil, Johannes

A major limitation of point-of-care RSV testing is the low sensitivity of currently available rapid antigen detection tests (RADT). In general, RADT sensitivity is strongly dependent on high viral load of respiratory specimens and therefore performs best in young infants with classical symptoms of RSV bronchiolitis. A pooled RADT sensitivity of 80% (95% confidence interval [CI], 76% to 83%) was reported for pediatric patients (4) . In our screening population of children Ͻ18 years of age who were hospitalized with any symptom of respiratory tract infection, we observed RADT sensitivity of 63% (95% CI, 55% to 72%) compared to reverse transcription-PCR (RT-PCR) (5), while in adults, sensitivities of different RADT were Ͻ25% (6). As an alternative to RADT, rapid nucleic acid amplification assays have been developed to facilitate early recognition of RSV infection. These assays provide high sensitivities but require a testing time of at least 1 h (7, 8) . The Alere i system is a rapid, automated in vitro diagnostic test which utilizes a nicking enzyme amplification reaction. The platform technology was previously developed for the detection of influenza virus (Alere i influenza) and provides test results in less than 15 min. The test is optimized for point-of-care settings and does not require specific training or experience in laboratory techniques. A number of studies have evaluated this rapid influenza test in comparison to both viral culture and RT-PCR, reporting sensitivities between 45 and 100% (9) (10) (11) (12) (13) (14) (15) . Recently, the platform has been extended with test cartridges for the detection of streptococcus A (Alere i Strep A) and RSV (Alere i RSV). Both assays are being introduced into routine clinical care. No data have been published regarding the sensitivity and specificity of the novel Alere i RSV test. The objective of our study was to evaluate the performance of the Alere i RSV test for rapid detection of RSV in children hospitalized with acute respiratory tract infection.