Rouleau Isabelle, Charest Hugues, Douville-Fradet Monique, Skowronski Danuta M, De Serres Gaston
Unité de Recherche en Santé Publique, Centre de Recherche du CHUL, Université Laval, Quebec, Canada.
J Clin Microbiol. 2009 Sep;47(9):2699-703. doi: 10.1128/JCM.00762-09. Epub 2009 Jul 8.
Provided test characteristics are adequate, point-of-care rapid antigen detection tests for influenza could improve the timeliness and appropriateness of clinical decisions. Our objective was to estimate the field sensitivity and specificity of the Quidel QuickVue Influenza A+B test in an ambulatory setting. The sensitivity and specificity of the Quidel QuickVue test was evaluated against reverse-transcriptase PCR (RT-PCR) on nasopharyngeal specimens collected over two consecutive influenza seasons from ambulatory patients consulting for influenza-like illness (ILI) within 7 days of ILI onset. A total of 491 patients with ILI (180 in 2006 to 2007 and 311 in 2007 to 2008) provided specimens that were tested both by PCR and by the Quidel QuickVue test. Among the 267 patients positive by PCR (55%), 52 were also positive by the QuickVue test, for an overall sensitivity of 19.5% (95% confidence interval [95% CI], 14.7% to 24.2%). Among the 221 PCR-negative patients, 2 were positive for influenza B virus by the rapid test (<1%), for an overall specificity of 99.1% (95% CI, 97.9 to 100%). The field sensitivity of the test varied little with the age or gender of the patient, immunization status, delay since the onset of symptoms, or influenza season. The sensitivity of the test was slightly but nonsignificantly higher for influenza B virus (23%) than for influenza A virus (18%). Despite its high specificity, the low sensitivity of the Quidel QuickVue Influenza A+B test is too poor to direct clinical decisions for ambulatory patients with ILI. Negative results cannot rule out the diagnosis of influenza, and in that context, this test is of questionable utility for routine application in the clinical setting.
如果检测特性足够，用于流感的即时快速抗原检测试验可提高临床决策的及时性和恰当性。我们的目的是评估Quidel QuickVue甲型和乙型流感检测试剂在门诊环境中的现场敏感性和特异性。针对在两个连续流感季节中，于流感样疾病（ILI）发病7天内前来门诊咨询的患者所采集的鼻咽标本，采用逆转录聚合酶链反应（RT-PCR）对Quidel QuickVue检测试剂的敏感性和特异性进行评估。共有491例ILI患者（2006年至2007年有180例，2007年至2008年有311例）提供了标本，这些标本同时进行了PCR检测和Quidel QuickVue检测。在267例PCR阳性患者（55%）中，有52例QuickVue检测也呈阳性，总体敏感性为19.5%（95%置信区间[95%CI]，14.7%至24.2%）。在221例PCR阴性患者中，快速检测有2例乙型流感病毒呈阳性（<1%），总体特异性为99.1%（95%CI，97.9至100%）。该检测的现场敏感性在患者的年龄、性别、免疫状态、症状出现后的延迟时间或流感季节方面变化不大。该检测对乙型流感病毒的敏感性（23%）略高于甲型流感病毒（18%），但差异无统计学意义。尽管Quidel QuickVue甲型和乙型流感检测试剂具有高特异性，但其低敏感性太差，无法为ILI门诊患者的临床决策提供指导。阴性结果不能排除流感诊断，在此背景下，该检测在临床环境中的常规应用效用存疑。
