快速流感抗原检测的诊断能力：对 2009 年 H1N1 大流行经验的重新评估。
Diagnostic capacity of rapid influenza antigen test: reappraisal with experience from the 2009 H1N1 pandemic.
机构信息
Division of Infectious Diseases, Department of Medicine, Chang Gung University and Memorial Hospital, Taoyuan, Taiwan.
出版信息
J Microbiol Immunol Infect. 2012 Apr;45(2):102-7. doi: 10.1016/j.jmii.2011.09.027. Epub 2011 Dec 16.
BACKGROUND
The rapid influenza antigen test (RIAT) has been questioned because of its poor sensitivity. Clinicians are confused as to what diagnostic help it may provide. RIAT was reappraised by other laboratory confirmatory tests for its diagnostic capacity.
METHODS
Records of RIAT, RT-PCR and virus culture, performed for upper respiratory tract samples during the period from July 2009 to January 2010, were reviewed. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of RIAT were evaluated with RT-PCR and virus culture as reference.
RESULTS
With either positive RT-PCR or positive virus culture as confirmation of presence of the virus, the overall sensitivity was 44.2% (235/532) and the overall PPV was 91.1% (235/258). With both negative RT-PCR and negative virus culture as confirmation of absence of the virus, the overall specificity was 98.2% (239/264) and the overall NPV was 92.6% (239/258). The PPV reached 96.2% during peak prevalence of infection and the NPV increased to 91.7% with low prevalence. The sensitivity for seasonal H3N2 was 56% (56/100), significantly better than the 39.6%, (156/394) for 2009 pandemic H1N1. Although RIAT positivity correlated to the viral load in samples, a substantial amount of negative RIAT samples had high viral load, with 16.8% (260/1548) of Ct value less than 36 and 8.8% (136/1548) of Ct value less than 31.
CONCLUSION
An algorithm is derived for the fast and inexpensive point-of-care laboratory test RIAT for appropriate application in clinical diagnosis of influenza virus infection. In peak seasons, positive RIAT confirms the diagnosis, with PPV over 96%. In low seasons, negative RIAT sufficiently excludes the diagnosis, with NPV over 91%. The sensitivity of RIAT may vary with different species of the influenza virus. Negative RIAT is not necessarily equal to low viral load in the upper respiratory tract or low infectivity of the patient.
背景
由于快速流感抗原检测（RIAT）的灵敏度较差，因此受到了质疑。临床医生对于它能提供什么样的诊断帮助感到困惑。通过其他实验室确认试验对 RIAT 的诊断能力进行了重新评估。
方法
回顾了 2009 年 7 月至 2010 年 1 月期间进行的上呼吸道样本的 RIAT、RT-PCR 和病毒培养记录。以 RT-PCR 和病毒培养为参考，评估 RIAT 的灵敏度、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
结果
以阳性 RT-PCR 或阳性病毒培养作为病毒存在的确认，总的灵敏度为 44.2%（235/532），总的 PPV 为 91.1%（235/258）。以阴性 RT-PCR 和阴性病毒培养作为病毒不存在的确认，总的特异性为 98.2%（239/264），总的 NPV 为 92.6%（239/258）。在感染高峰期时，PPV 达到 96.2%，而在流行率较低时，NPV 增加至 91.7%。季节性 H3N2 的灵敏度为 56%（56/100），明显优于 2009 年甲型 H1N1 大流行时的 39.6%（156/394）。尽管 RIAT 阳性与样本中的病毒载量相关，但大量 RIAT 阴性样本的病毒载量较高，其中 16.8%（260/1548）的 Ct 值小于 36，8.8%（136/1548）的 Ct 值小于 31。
结论
为了在流感病毒感染的临床诊断中进行快速、经济的即时护理实验室测试 RIAT，我们推导出了一个算法。在高峰期，阳性 RIAT 可确认诊断，PPV 超过 96%。在低流行季节，阴性 RIAT 足以排除诊断，NPV 超过 91%。RIAT 的灵敏度可能因流感病毒的不同物种而有所不同。阴性 RIAT 并不一定等于上呼吸道的低病毒载量或患者的低传染性。
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