Sensitivity of the Quidel Sofia Fluorescent Immunoassay Compared With 2 Nucleic Acid Assays and Viral Culture to Detect Pandemic Influenza A(H1N1)pdm09
Sensitivity of the Quidel Sofia Fluorescent Immunoassay Compared With 2 Nucleic Acid Assays and Viral Culture to Detect Pandemic Influenza A(H1N1)pdm09
复制标题
DOI：
10.1309/lmrxbn8p59itdhqz
复制
发表时间：
2015-06-01
期刊：
影响因子：
--
通讯作者：
Ferrieri, Patricia
中科院分区：
文献类型：
--
作者：
Arbefeville, Sophie S.;Fickle, Ann R.;Ferrieri, Patricia
为了在护理时确认流感的诊断，医疗保健专业人员可能会依靠快速流感诊断测试(RIDT)。与病毒培养或实时逆转录聚合酶链式反应(RRT-PCR)相比，RIDT具有低到中等的敏感性。随着2009年甲型H1N1流感大流行(Pdm09)毒株在2013年和2014年卷土重来，我们评估了美国食品和药物管理局(FDA)批准的SOFIA甲型H1N1流感A+B荧光免疫分析法检测上呼吸道样本中甲型H1N1流感pdm09的准确性。在3个月的时间里，我们收集了40份通过聚合酶链式反应和/或培养对H1N1 pdm09亚型甲型流感检测呈阳性的样本。在40个样本中，27个(67.5%)经SOFIA检测对流感A呈阳性，在经SOFIA检测为阴性的13个样本中，有4个合并感染，由Genmark诊断电子传感器呼吸道病毒小组检测。Riot Sofia检测甲型H1N1流感(H1N1)pdm09的敏感性与之前报道的较旧RIDT的10%至75%相当。
To confirm a diagnosis of influenza at the point of care, healthcare professionals may rely on rapid influenza diagnostic tests (RIDTs). RIDTs have low to moderate sensitivity compared with viral culture or real-time reverse-transcription polymerase chain reaction (rRT-PCR). With the resurgence of the influenza A (Flu A; subtype H1N1) pandemic 2009 (pdm09) strain in the years 2013 and 2014, we evaluated the accuracy of the United State Food and Drug Administration (FDA)-approved Sofia Influenza A+B Fluorescent Immunoassay to detect epidemic Flu A(H1N1)pdm09 in specimens from the upper-respiratory tract. During a 3-month period, we collected 40 specimens that tested positive via PCR and/or culture for Flu A of the H1N1 pdm09 subtype. Of the 40 specimens, 27 tested positive (67.5%) via Sofia assay for Flu A. Of the 13 specimens with a negative result via Sofia testing, 4 had coinfection, as detected by the GenMark Diagnostics eSensor Respiratory Viral Panel. This sensitivity of the RIOT Sofia assay to detect Flu A(H1N1) pdm09 was comparable to previously reported sensitivities ranging from 10% to 75% for older RIDTs.