Department of Laboratory Medicine, College of Medicine, Korea University, Seoul, Republic of Korea.
J Clin Virol. 2013 Aug;57(4):338-42. doi: 10.1016/j.jcv.2013.04.014. Epub 2013 Jun 3.
Various kinds of commercial molecular systems have been developed for fast and more accurate detection of respiratory viruses. Anyplex™ II RV16 [RV16] was designed for simultaneous detection of 16 respiratory viruses using multiplex PCR coupled with TOCE™ technology.
To compare the performance of RV16 with those of culture and Seeplex(®) RV15 ACE [RV15] by determining their sensitivity and specificity.
Seven hundred and thirty respiratory samples were tested by modified shell vial culture method, RV16, and RV15. For molecular tests, automated nucleic acid extraction and liquid handling system using MICROLAB Nimbus IVD (Hamilton, USA) was adopted to maximize the workflow and accuracy. Performance of each assay was determined against a composite reference standard.
Two hundred and one samples (28%) out of 730 samples were positive by culture, while additional 281 (39%) were positive by RV16 or RV15. Sensitivities of RV16, RV15, and culture for virus tested were as follows: 100/93/63% for influenza A, 90/80/69% for influenza B, 98/94/63% for RSV, 98/52/23% for adenovirus, and 100/75/46% for PIV. For viruses not covered by culture, sensitivities of RV16 and RV15 were as follows: 99/81% for rhinovirus, 92/100% for coronavirus OC43, 100/56% for coronavirus 229E/NL63, 92/88% for metapneumovirus, 100/62% for bocavirus, and 91/91% for enterovirus. Overall, the specificities of culture, RV16, and RV15 (Seegene) were 100/99.9/99.9%.
RV16 assay was superior to culture method and RV15 and will be a promising tool for patient management and public health epidemiology.
为了实现快速、更准确地检测呼吸道病毒，已经开发出了各种商业分子系统。Anyplex™ II RV16（RV16）采用多重 PCR 结合 TOCE™技术，设计用于同时检测 16 种呼吸道病毒。
通过确定敏感性和特异性，比较 RV16 与培养和 Seeplex(®) RV15 ACE[RV15]的性能。
采用改良的壳瓶培养法、RV16 和 RV15 对 730 例呼吸道样本进行检测。对于分子检测，采用 MICROLAB Nimbus IVD（美国汉密尔顿）自动化核酸提取和液体处理系统，以最大限度地提高工作流程和准确性。每种检测方法的性能均针对综合参考标准进行确定。
730 例标本中，210 例（28%）经培养阳性，281 例（39%）经 RV16 或 RV15 阳性。RV16、RV15 和培养法对检测病毒的敏感性如下：流感 A 为 100/93/63%，流感 B 为 90/80/69%，RSV 为 98/94/63%，腺病毒为 98/52/23%，PIV 为 100/75/46%。对于培养法未覆盖的病毒，RV16 和 RV15 的敏感性如下：鼻病毒为 99/81%，冠状病毒 OC43 为 92/100%，冠状病毒 229E/NL63 为 100/56%，偏肺病毒为 92/88%，博卡病毒为 100/62%，肠道病毒为 91/91%。总体而言，培养法、RV16 和 RV15（塞根）的特异性均为 100/99.9/99.9%。
RV16 检测优于培养法和 RV15，将成为患者管理和公共卫生流行病学的有前途的工具。
