Yun Seung Gyu, Kim Min Young, Choi Jong Moon, Lee Chang Kyu, Lim Chae Seung, Cho Yunjung, Suh In Bum
Department of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
J Clin Lab Anal. 2018 Feb;32(2). doi: 10.1002/jcla.22230. Epub 2017 Apr 11.
Due to its great sensitivity, the nucleic acid amplification test (NAAT) is widely used for detection of respiratory viruses (RV). However, few reports have described a direct comparison between multiplex RT-PCR assays for RV. The objective of this study was to perform a direct comparison of three multiplex RT-PCR assays for the detection of respiratory viruses.
A total of 201 respiratory samples (161 nasopharyngeal swab samples and 40 sputum samples) were tested with three commercial RV assays: Seegene Anyplex II RV16 (AP), LG AdvanSure RV (AD), and Biosewoom Real-Q RV (RQ). The additional tests for the discrepant results were conducted by repeat RV assay or monoplex PCR coupled direct sequencing. Data analysis using percent agreement, kappa, and prevalence-adjusted and bias-adjusted kappa (PABAK) values was performed for comparisons among the three RV assays.
Of the 201 samples, AP, AD, and RQ detected 105 (52.2%), 99 (49.3%), and 95 (47.3%) positive cases respectively. The overall agreement, kappa, and PABAK values for the three assays ranged between 97%-98%, 0.76-0.86, and 0.93-0.96 respectively. The performance of the three assays was very similar, with 94%-100% agreement for all comparisons, each virus types. The additional testing of samples showed discrepant results demonstrating that AD assay had the highest rate of concordance with original results.
We suggest that all multiplex assay would be suitable for the detection of for respiratory viruses in clinical setting.
由于核酸扩增检测（NAAT）具有高度敏感性，因此被广泛用于呼吸道病毒（RV）的检测。然而，很少有报告描述针对呼吸道病毒的多重逆转录聚合酶链反应（RT-PCR）检测方法之间的直接比较。本研究的目的是对三种用于检测呼吸道病毒的多重RT-PCR检测方法进行直接比较。
使用三种商用呼吸道病毒检测方法对总共201份呼吸道样本（161份鼻咽拭子样本和40份痰液样本）进行检测：Seegene Anyplex II RV16（AP）、LG AdvanSure RV（AD）和Biosewoom Real-Q RV（RQ）。对结果不一致的样本进行额外检测，方法是重复进行呼吸道病毒检测或采用单重PCR结合直接测序。使用百分比一致性、kappa值以及患病率调整和偏差调整的kappa（PABAK）值进行数据分析，以比较三种呼吸道病毒检测方法。
在201份样本中，AP、AD和RQ分别检测出105例（52.2%）、99例（49.3%）和95例（47.3%）阳性病例。三种检测方法的总体一致性、kappa值和PABAK值分别在97%-98%、0.76-0.86和0.93-0.96之间。三种检测方法的性能非常相似，所有比较（每种病毒类型）的一致性为94%-100%。对样本进行的额外检测显示结果存在差异，表明AD检测方法与原始结果的一致性率最高。
我们建议所有多重检测方法均适用于临床环境中呼吸道病毒的检测。
