Comparison of the directigen Flu A+B test, the QuickVue influenza test, and clinical case definition to viral culture and reverse transcription-PCR for rapid diagnosis of influenza virus infection
Comparison of the directigen Flu A+B test, the QuickVue influenza test, and clinical case definition to viral culture and reverse transcription-PCR for rapid diagnosis of influenza virus infection
复制标题
DOI：
10.1128/jcm.41.8.3487-3493.2003
复制
发表时间：
2003-08-01
影响因子：
9.4
通讯作者：
Frost, EH
中科院分区：
文献类型：
--
作者：
Ruest, A;Michaud, S;Frost, EH
基于发热和咳嗽组合的流感病毒感染临床病例定义和两种快速流感诊断试验的诊断性能，即Directigen Flu A+B试验(Directigen；BD诊断系统，马里兰州斯帕克斯)以及QuickVue流感检测(QuickVue；加利福尼亚州圣地亚哥的Quidel)，与2000-2001年流感季节的病毒培养和内部逆转录(RT)-PCR进行了比较。对192例患者的200个连续鼻咽抽吸物进行了分析，其中包括122名成人和70名儿童。病毒培养检出甲型流感病毒16份，乙型流感病毒55份；逆转录-聚合酶链式反应检测甲型流感病毒21份，乙型流感病毒。以RT-PCR为参考标准，Directigen、QuickVue和发热咳嗽组合阳性的似然比分别为40.0、8.6和1.4，而阴性的似然比分别为0.22、0.16和0.48。我们的研究表明：(I)流感临床病例定义的低特异度(35%至58%)和差的阳性预测值(41%至60%)排除了其在流行期间用于预测流感病毒感染的可能性，特别是在考虑医院感染控制决策的情况下；(Ii)Directigen具有比QuickVue更高的诊断效率，但与更多的无效结果有关；(Iii)快速诊断试验对成人样本的敏感性显著低于儿童样本，假阴性率高达29%；与病毒培养相比，RT-PCR检测到更多的流感病例，这种更高的准确性使其成为更有用的参考标准。
The diagnostic performances of the clinical case definition of influenza virus infection based on the combination of fever and cough and of two rapid influenza diagnostic tests, the Directigen Flu A+B test (Directigen; BD Diagnostic Systems, Sparks, Md.) and the QuickVue influenza test (QuickVue; Quidel, San Diego, Calif.), were compared to those of viral culture and an in-house reverse transcription (RT)-PCR during the 2000-2001 flu season. Two hundred consecutive nasopharyngeal aspirates were analyzed from 192 patients, including 122 adults and 70 children. Viral culture identified influenza virus A in 16 samples and influenza virus B in 55 samples, whereas RT-PCR identified influenza virus A in 21 samples and influenza virus B in 64 samples. When RT-PCR was used as the reference standard, the likelihood ratios for a positive test were 40.0 for Directigen, 8.6 for QuickVue, and 1.4 for the combination of fever and cough, whereas the likelihood ratios for a negative test were 0.22, 0.16, and 0.48, respectively. Our study suggests that (i) the poor specificity (35 to 58%) and the poor positive predictive value (41 to 60%) of the clinical case definition of influenza preclude its use for prediction of influenza virus infections during epidemics, especially when infection control decision making in the hospital setting is considered; (ii) Directigen has a higher diagnostic yield than QuickVue but is associated with a larger number of invalid results; (iii) the sensitivities of the rapid diagnostic tests are significantly lower with samples from adults than with samples from children, with the rates of false-negative results reaching up to 29%; and (iv) RT-PCR detects more cases of influenza than viral culture, and this greater accuracy makes it a more useful reference standard.