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三种用于快速检测甲型和乙型流感病毒的免疫分析试剂盒的评估

Evaluation of three immunoassay kits for rapid detection of influenza virus A and B.

作者信息

Weinberg Adriana, Walker Miranda L

机构信息

University of Colorado Health Sciences Center, 4200 E 9th Ave., Campus box C227, Denver, CO 80220, USA.

出版信息

Clin Diagn Lab Immunol. 2005 Mar;12(3):367-70. doi: 10.1128/CDLI.12.3.367-370.2005.

Abstract

Influenza causes high morbidity and mortality in very young and elderly individuals, which can be controlled with antivirals and/or vaccines. The success of therapeutic measures is predicated on the rapid and precise diagnosis of the infection. We compared three rapid influenza immunoassay (RIIA) kits for the diagnosis of influenza virus A and B using 178 respiratory specimens submitted for routine testing. BD Directigen Flu A+B (Directigen), Directigen EZ Flu A+B (EZ), and NOW Flu A NOW Flu B (NOW; Binax) tests had comparable combined influenza virus A and B specificities, varying from 94 to 98%. In contrast, the sensitivity of EZ was significantly lower (39%) than that of NOW (76%) and marginally lower than that of Directigen (56%). The differences in sensitivity were most evident in patients who were >9 years old (Directigen, 53%; EZ, 32%; and NOW, 69%). Among specimens, bronchoalveolar lavage fluids yielded the most discrepant results, with sensitivities varying from 0 (EZ) to 100% (NOW), followed by nasopharyngeal swabs (sensitivities of 27 to 100%) and nasal washes (50 to 81%). The Directigen kit format allowed for faster completion but more cumbersome performance and more difficult interpretation compared with the other two kits. Overall, NOW provided the most accurate diagnoses and had user-friendly technical characteristics. However, the low overall sensitivity of the RIIAs indicates that these can be used as screening tools only.

摘要

流感在婴幼儿和老年人中会导致高发病率和高死亡率,不过可以通过抗病毒药物和/或疫苗加以控制。治疗措施的成功与否取决于对感染的快速准确诊断。我们使用178份提交进行常规检测的呼吸道标本,比较了三种用于诊断甲型和乙型流感病毒的快速流感免疫测定(RIIA)试剂盒。BD Directigen Flu A+B(Directigen)、Directigen EZ Flu A+B(EZ)和NOW Flu A NOW Flu B(NOW;Binax)检测对甲型和乙型流感病毒的综合特异性相当,在94%至98%之间。相比之下,EZ的灵敏度(39%)显著低于NOW(76%),略低于Directigen(56%)。灵敏度的差异在9岁以上的患者中最为明显(Directigen为53%;EZ为32%;NOW为69%)。在标本中,支气管肺泡灌洗液产生的结果差异最大,灵敏度从0(EZ)到100%(NOW)不等,其次是鼻咽拭子(灵敏度为27%至100%)和鼻腔冲洗液(50%至81%)。与其他两种试剂盒相比,Directigen试剂盒形式完成检测更快,但操作更繁琐,解读更困难。总体而言,NOW提供了最准确的诊断,并且具有用户友好的技术特性。然而,RIIA的总体灵敏度较低,这表明它们只能用作筛查工具。

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