Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, East Meadow, NY 11554, USA.
Am J Clin Pathol. 2010 Dec;134(6):910-4. doi: 10.1309/AJCPR7LTR5UUUYDT.
Identification of the 2009 H1N1 influenza A virus requires emergency use authorized (EUA) molecular reverse transcriptase-polymerase chain reaction. Laboratories lacking molecular capabilities outsource testing, which is costly and may delay result reporting. A fluorescent antibody (FA; D(3) Ultra 2009 H1N1 influenza A virus ID Kit, Diagnostic Hybrids, Athens, OH) recently received Food and Drug Administration EUA status for 2009 H1N1 virus identification. The performance of this FA reagent was evaluated in this study. Influenza A-positive nasopharyngeal specimens (seasonal H1, H3, and 2009 H1N1) were prepared for culture and FA testing and were stained using influenza A antibodies and the 2009 H1N1 reagent. Other respiratory viruses were also evaluated. The FA reagent demonstrated 100% sensitivity and specificity. Bright, apple-green fluorescence was effortlessly identified in culture-positive cells, particularly around cell membrane perimeters. Laboratory-prepared slides were preferred over bedside-prepared specimens because background fluorescence obscured identification in the latter. The new FA reagent provides an accurate, rapid, and inexpensive assay for identifying the 2009 H1N1 virus in nonmolecular diagnostic laboratories.
鉴定 2009 年 H1N1 流感病毒需要紧急使用授权（EUA）的分子逆转录-聚合酶链反应。缺乏分子检测能力的实验室将检测工作外包出去，这既昂贵又可能导致结果报告延迟。一种荧光抗体（FA；D(3)Ultra 2009 H1N1 流感 A 病毒 ID 试剂盒，Diagnostic Hybrids，Athens，OH）最近获得了 FDA 对 2009 年 H1N1 病毒鉴定的 EUA 批准。本研究评估了这种 FA 试剂的性能。制备了用于培养和 FA 检测的甲型流感阳性鼻咽标本（季节性 H1、H3 和 2009 年 H1N1），并用流感 A 抗体和 2009 年 H1N1 试剂对其进行了染色。还评估了其他呼吸道病毒。FA 试剂显示出 100%的敏感性和特异性。在培养阳性细胞中，可以轻松地识别出明亮的苹果绿荧光，尤其是在细胞膜边缘周围。与床边制备的标本相比，实验室制备的载玻片更受欢迎，因为后者的背景荧光会妨碍识别。新的 FA 试剂为非分子诊断实验室鉴定 2009 年 H1N1 病毒提供了一种准确、快速且廉价的检测方法。
