Department of Pediatrics, San Antonio Military Medical Center, Ft Sam, Houston, Texas 78234, USA.
J Med Virol. 2012 Nov;84(11):1699-702. doi: 10.1002/jmv.23374.
Rapid antigen tests are commonly used by clinicians for rapid, simple, point-of-care testing. Five rapid antigen tests were shown to have low sensitivity (40.3-58.8%) when compared to real-time RT-PCR using nasal wash specimens from patients with influenza-like-illness (N = 167) that were collected previously and confirmed as 2009 pandemic influenza A (H1N1)-positive by PCR. Rapid antigen test sensitivity correlated with virus levels in nasal secretions when comparisons were made to cycle threshold (C(T)) values obtained from real-time RT-PCR. When C(T) values are <25 (equating to viral concentrations of >10(4) TCID(50)/ml) sensitivity for all five rapid antigen kits was high (range: 83-94% positive); however, when C(T) values are >30 (10(2) TCID(50)/ml), sensitivities of only 16-18% were observed for four of five rapid antigen kits. The Directigen EZ Flu A + B test detected more positive samples (35%) at lower viral concentrations with C(T) values >30 when compared with other commercial kits (P = 0.05). Rapid antigen test results must be interpreted with caution, and negative specimens may need confirmation by sensitive molecular assays.
快速抗原检测通常由临床医生用于快速、简单的床边检测。与使用之前采集的、经 PCR 确认为 2009 年大流行流感 A（H1N1）阳性的流感样疾病患者的鼻洗液标本进行的实时 RT-PCR 相比，五种快速抗原检测的敏感性较低（40.3-58.8%）。当将快速抗原检测与实时 RT-PCR 的循环阈值（C(T)）值进行比较时，其敏感性与鼻腔分泌物中的病毒水平相关。当 C(T)值<25（相当于病毒浓度>10(4) TCID(50)/ml）时，所有五种快速抗原试剂盒的敏感性均较高（范围：83-94%阳性）；然而，当 C(T)值>30（10(2) TCID(50)/ml）时，五种快速抗原试剂盒中的四种的敏感性仅为 16-18%。与其他商业试剂盒相比，Directigen EZ Flu A+B 检测在 C(T)值>30 时，在较低的病毒浓度下检测到更多的阳性样本（35%）（P=0.05）。快速抗原检测结果必须谨慎解释，阴性标本可能需要通过敏感的分子检测进行确认。
