Department of Laboratory Medicine, Chonbuk National University Hospital, Jeonju, Korea.
Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Korea.
Ann Lab Med. 2018 Jan;38(1):46-50. doi: 10.3343/alm.2018.38.1.46.
The Allplex Respiratory Panel 1/2/3 (All16) is a multiplex PCR assay for detecting 16 respiratory viruses with influenza A virus (FluA) subtyping, and the first clinical assay based on multiple detection temperatures. We compared the results between All16 and Anyplex II RV16 (Any16) in 426 clinical samples. Samples showing discrepancies between the two tests were further tested using monoplex PCR. FluA subtyping based on the hemagglutinin type results of All16, which yielded H1, H3, and non-H1/H3, was compared with the results of the BioFire FilmArray respiratory panel. The positive and negative percent agreements and kappa value for each virus between All16 and Any16 ranged from 54.5-100.0%, 84.7-100.0%, and 0.57-1.00, respectively. FluA subtype results from All16 for 26 samples were consistent with those from FilmArray. Good agreement was observed between the two methods, except when analyzing human enterovirus (kappa value 0.70), and the All16 showed reliable FluA subtyping results. For parainfluenza virus 3, the All16 was more sensitive than Any16. When testing 28 samples simultaneously, the mean test time and hands-on time were 4.3 and 0.5 hours, respectively in All16. In conclusion, All16 showed reliable performance, but further studies are needed regarding human enterovirus analysis.
Allplex Respiratory Panel 1/2/3 (All16) 是一种用于检测 16 种呼吸道病毒的多重 PCR 检测方法，包括流感 A 病毒 (FluA) 亚型检测，是首个基于多种检测温度的临床检测方法。我们将 All16 与 Anyplex II RV16 (Any16) 在 426 个临床样本中的结果进行了比较。对两种检测方法结果不一致的样本进一步使用单重 PCR 进行了检测。All16 基于血凝素类型的 FluA 亚型结果（H1、H3 和非 H1/H3）与 BioFire FilmArray 呼吸道检测面板的结果进行了比较。All16 与 Any16 之间每种病毒的阳性和阴性符合率以及 Kappa 值分别为 54.5-100.0%、84.7-100.0%和 0.57-1.00。26 个样本的 All16 流感 A 亚型结果与 FilmArray 的结果一致。两种方法之间的一致性良好，除了在分析人类肠道病毒时（Kappa 值为 0.70），All16 显示出可靠的 FluA 亚型检测结果。对于副流感病毒 3，All16 比 Any16 更敏感。在同时检测 28 个样本时，All16 的平均检测时间和操作时间分别为 4.3 小时和 0.5 小时。总之，All16 表现出可靠的性能，但仍需进一步研究人类肠道病毒的分析。
