Japanese Journal of Infectious Diseases
Online ISSN : 1884-2836
Print ISSN : 1344-6304
ISSN-L : 1344-6304

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Laboratory evaluation of rapid antigen detection tests for more-sensitive detection of Respiratory syncytial virus antigen
Yu SunJie DengYuan QianRunan ZhuFang WangRun TianRi DeLinqing Zhao
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JOURNAL FREE ACCESS Advance online publication

Article ID: JJID.2018.528

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Abstract

We evaluated two currently available rapid antigen detection tests (RADTs) for Respiratory syncytial virus (RSV), Sofia® RSV FIA and BinaxNOW RSV Card (BinaxNOW). Between November 2017 and February 2018, 395 nasopharyngeal swabs were collected from children diagnosed with acute respiratory infections, and were evaluated with these RADTs, reverse transcription–quantitative real-time PCR (RT–qPCR), and a direct immunofluorescence assay (DFA). The sensitivity of Sofia® RSV FIA (80.82%) was significantly higher than that of BinaxNOW (53.42%) when RT–qPCR was used as the standard. This was confirmed with DFA. The sensitivities of Sofia® RSV FIA (85.4% [41/48]) and BinaxNOW (58.3% [28/48]) were higher for RSV A than for RSV B (69.6% [16/23] and 43.5% [10/23], respectively). The optimal critical cycle threshold (Ct) values on RT–qPCR that correlated with Sofia® RSV FIA and BinaxNOW were 24 and 22, respectively. The kappa value for Sofia® RSV FIA and RT–qPCR in the patients aged ≤ 2 years was 0.962, but 0.648 in those aged > 2 years. Thus, Sofia® RSV FIA is more sensitive than BinaxNOW; its results were affected by the RSV viral strain and load. It is more effective in children aged ≤ 2 years than in those aged > 2 years.

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