Division of Infectious Diseases, Department of Medicine, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Department of Laboratory Medicine, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
J Med Virol. 2018 Jun;90(6):1010-1018. doi: 10.1002/jmv.25043. Epub 2018 Mar 12.
To evaluate the diagnostic performance of the Sofia influenza A+B fluorescent immunoassay (Sofia FIA), we performed a prospective study at the Chang Gung Memorial Hospital in Taiwan from January 2012 to December 2013. Patients who presented at out-patient clinics or the emergency department with influenza-like illness were included. Upper respiratory tract specimens were collected from oropharynx or nasopharynx. Performance of the Sofia FIA was compared to that of the Formosa One Sure Flu A/B Rapid Test. A Real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) and/or virus culture were used as reference standards. Of the 109 enrolled patients, the sensitivity, specificity, positive, and negative predictive values of the Sofia FIA to detect influenza A virus were 82%, 89%, 77%, and 89%, respectively. These parameters were 100% when the samples were from nasopharynx. The positive predictive value for influenza B virus detection was 29%. The sensitivity of the Sofia FIA for detection of influenza A virus was 93% between days 2 and 4 after onset of symptoms. For specimens with low viral loads (RT-PCR cycle threshold between 30 and 34.9), the sensitivity of The Sofia FIA was 83% (10/12). The Sofia FIA performed effectively in detecting influenza A virus infection. With nasopharyngeal samples, the performance was comparable to RT-PCR. Although influenza viral load typically decreases with time, the Sofia FIA was sensitive enough to identify influenza infecting patients presenting after several days of illness. However, a high false positive rate limits the assay's usefulness to identify influenza B virus infection.
为了评估 Sofia 流感 A+B 荧光免疫分析仪（Sofia FIA）的诊断性能，我们在 2012 年 1 月至 2013 年 12 月在台湾长庚纪念医院进行了一项前瞻性研究。研究纳入了因流感样疾病而在门诊或急诊就诊的患者。采集鼻咽或口咽的上呼吸道标本。Sofia FIA 的性能与 Formosa One Sure Flu A/B 快速检测进行了比较。实时逆转录聚合酶链反应（RT-PCR）和/或病毒培养被用作参考标准。在 109 名入组患者中，Sofia FIA 检测甲型流感病毒的敏感性、特异性、阳性预测值和阴性预测值分别为 82%、89%、77%和 89%。当样本来自鼻咽时，这些参数均为 100%。乙型流感病毒检测的阳性预测值为 29%。Sofia FIA 在症状出现后第 2 至 4 天检测甲型流感病毒的敏感性为 93%。对于病毒载量较低的标本（RT-PCR 循环阈值为 30 至 34.9），Sofia FIA 的敏感性为 83%（10/12）。Sofia FIA 能有效检测甲型流感病毒感染。使用鼻咽样本时，其性能与 RT-PCR 相当。尽管流感病毒载量通常随时间下降，但 Sofia FIA 足够灵敏，能够识别出患病数天后就诊的流感感染患者。然而，较高的假阳性率限制了该检测方法用于识别乙型流感病毒感染的用途。
