Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Am J Clin Pathol. 2013 May;139(5):684-9. doi: 10.1309/AJCP7ZTLJCP3LLMA.
This report describes the clinical evaluation of a novel fluorescent immunoassay (FIA), Sofia Influenza A+B FIA (Quidel, San Diego, CA), for the rapid detection and differentiation of influenza A and B viruses. A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates. The overall sensitivity and specificity for influenza A virus vs virus culture were 94% and 95%, respectively, and for influenza B virus were 89% and 96%, respectively. Fourteen hundred and sixty-one specimens were available for testing with reverse transcriptase-polymerase chain reaction (RT-PCR). The sensitivity of the Sofia Influenza A+B FIA for detecting influenza A and B viruses compared with the RT-PCR method was 78% and 86%, respectively. A high percentage of the positive specimens had low cycle threshold values, and almost all of these were positive with the Sofia test. This high level of sensitivity demonstrates that the Sofia influenza A+B FIA could improve the usefulness of rapid influenza virus testing.
本报告描述了一种新型荧光免疫分析（FIA）试剂盒——Sofia 流感 A+B FIA（奎德尔，圣地亚哥，CA）的临床评估，用于快速检测和区分流感 A 和 B 病毒。共有 2047 名受试者提供了鼻拭子和鼻咽拭子或抽吸物。该试剂盒检测流感 A 病毒的总体灵敏度和特异性分别为 94%和 95%，检测流感 B 病毒的灵敏度和特异性分别为 89%和 96%。有 1461 份标本可用于逆转录-聚合酶链反应（RT-PCR）检测。Sofia 流感 A+B FIA 检测流感 A 和 B 病毒的灵敏度与 RT-PCR 方法相比，分别为 78%和 86%。高比例的阳性标本具有低循环阈值值，几乎所有这些标本用 Sofia 检测都是阳性的。这种高灵敏度表明，Sofia 流感 A+B FIA 可以提高快速流感病毒检测的实用性。
