Bhattacharya S, Osman H
HPA West Midlands Public Health Laboratory, Birmingham Heartlands Hospital, UK.
Indian J Med Microbiol. 2011 Jan-Mar;29(1):19-21. doi: 10.4103/0255-0857.76518.
A rapid test for influenza viruses (Binax NOW® ) was evaluated.
In season-1, 35 respiratory samples were tested retrospectively; in season-2, 45 samples were tested prospectively [gold-standard: viral culture in season-1, culture+ reverse transcriptase-polymerase chain reaction (RT-PCR) in season-2].
Sensitivity for Binax for influenza A was 59.3 and 0% in season-1 and -2, respectively. Sensitivity was low for influenza B (33.3% in season-1, 26.1% in season-2). Samples having low viral load were more likely to have a negative Binax test. Specificity of Binax was high (100 and 94.7% with influenza A and B, respectively).
Sensitivity information provided in the kit insert does not always reflect post licensure performance in clinical settings.
对一种流感病毒快速检测方法(Binax NOW®)进行评估。
在第一季,对35份呼吸道样本进行回顾性检测;在第二季,对45份样本进行前瞻性检测[金标准:第一季为病毒培养,第二季为培养 + 逆转录 - 聚合酶链反应(RT-PCR)]。
Binax对甲型流感的敏感性在第一季和第二季分别为59.3%和0%。对乙型流感的敏感性较低(第一季为33.3%,第二季为26.1%)。病毒载量低的样本更有可能Binax检测呈阴性。Binax的特异性较高(甲型和乙型流感分别为100%和94.7%)。
试剂盒说明书中提供的敏感性信息并不总是反映其上市后在临床环境中的表现。