Koul P A, Mir H, Bhat M A, Khan U H, Khan M M, Chadha M S, Lal R B
Department of Internal and Pulmonary Medicine and MSM Project for Influenza, Sher I Kashmir Institute of Medical Sciences, Soura, Srinagar, Jammu and Kashmir, India.
Indian J Med Microbiol. 2015 Feb;33 Suppl(Suppl):26-31. doi: 10.4103/0255-0857.148831.
Rapid point-of-care (POC) tests provide an economical alternative for rapid diagnosis and treatment of influenza, especially in public health emergency situations.
To test the performance of a rapid influenza diagnostic test, QuickVue (Quidel) as a POC test against a real-time polymerase chain reaction (RT-PCR) assay for detection of influenza A and B in a developing country setting.
In a prospective observational design, 600 patients with influenza-like illness (ILI) or with severe acute respiratory illness (SARI) who were referred to the Influenza Clinic of a tertiary care hospital in Srinagar, India from September 2012 to April 2013, were enrolled for diagnostic testing for influenza using QuickVue or RT-PCR. All influenza A-positive patients by RT-PCR were further subtyped using primers and probes for A/H1pdm09 and A/H3.
Of the 600 patients, 186 tested positive for influenza A or B by RT-PCR (90 A/H1N1pdm09, 7 A/H3 and 89 influenza B), whereas only 43 tested positive for influenza (influenza A=22 and influenza B=21) by QuickVue. Thus, the sensitivity of the QuickVue was only 23% (95% confidence interval, CI: 17.3-29.8) and specificity was 100% (95% CI: 99.1-100) with a positive predictive value (PPV) of 100% (95% CI 91.8-100) and a negative predictive value (NPV) of 74.3% (95% CI: 70.5-77.9) as compared to RT-PCR.
The high specificity of QuickVue suggest that this POC test can be a useful tool for patient management or triaging during a public health crisis but a low sensitivity suggests that a negative test result need to be further tested using RT-PCR.
即时(point - of - care，POC)快速检测为流感的快速诊断和治疗提供了一种经济的替代方法，尤其是在突发公共卫生事件中。
在一个发展中国家的环境中，针对实时聚合酶链反应(real - time polymerase chain reaction，RT - PCR)检测甲型和乙型流感，测试一种快速流感诊断检测试剂QuickVue(Quidel)作为POC检测的性能。
采用前瞻性观察设计，2012年9月至2013年4月期间，将600例流感样疾病(influenza - like illness，ILI)或严重急性呼吸疾病(severe acute respiratory illness，SARI)患者转诊至印度斯利那加一家三级医院的流感门诊，使用QuickVue或RT - PCR进行流感诊断检测。所有RT - PCR检测为甲型流感阳性的患者，进一步使用针对A/H1pdm09和A/H3的引物和探针进行亚型分型。
600例患者中，186例通过RT - PCR检测甲型或乙型流感呈阳性(90例A/H1N1pdm09、7例A/H3和89例乙型流感)，而QuickVue检测流感呈阳性的仅43例(甲型流感 = 22例，乙型流感 = 21例)。因此，与RT - PCR相比，QuickVue的敏感性仅为23%(95%置信区间，CI：17.3 - 29.8)，特异性为100%(95%CI：99.1 - 100)，阳性预测值(positive predictive value，PPV)为100%(95%CI 91.8 - 100)，阴性预测值(negative predictive value，NPV)为74.3%(95%CI：70.5 - 77.9)。
QuickVue的高特异性表明，这种POC检测在突发公共卫生危机期间可作为患者管理或分诊的有用工具，但低敏感性表明阴性检测结果需要进一步使用RT - PCR进行检测。
