Performance Evaluation of a Novel Fully Automated Real-Time Reverse Transcriptase-Polymerase Chain Reaction Kit for the Detection of Norovirus.

Tomohiro Hosoda, Yuki Uehara, Naoto Matsuda, Yukiko Kawase', Mika Tanei, Yuichiro Haba, Ayako Nakamura, Yoko Tabe, Toshio Naito, Akimichi Ohsaka
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Abstract

Objective: Rapid and accurate detection of norovirus is essential for the prevention and control of the out- breaks. The aim of this study is to compare the fully automated real-time reverse transcriptase-polymerase chain reaction method (EV-kit) with the conventional immunochromatography method (IC) for diagnosis of norovirus, using one-tube reverse transcriptase-polymerase chain reaction (RT-PCR) analysis as the gold standard.

Methods: Between November 2013 and March 2014, clinical data and fecal specimens (53 bulk stools, 41 rectal swabs) were collected from 94 patients who visited the Department of General Medicine, Juntendo University Hospital for acute diarrhea. The sensitivity and specificity of each study test was determined by comparing with RT-PCR, and reproducibility was analyzed by determining Cohen's kappa coefficients.

Results: Of 94 specimens, 35(37%, 26 bulk stools, 9 rectal swabs) were positive for norovirus antigen by RT-PCR. The sensitivity, specificity, and Cohen's kappa coefficient of the EV-kit were 91% (32/35), 88% (52/59), and 0.778, respectively; those of the IC were 54% (19/35), 90% (53/59), and 0.468, respectively. For rectal swab testing, the sensitivity was 89% (8/9) for the EV-kit and 33% (3/9) for IC, ana that for bulk stool testing was 92% (24/26) for the EV-kit and 62% (16/26) for IC.

Conclusions: Use of the EV-kit was significantly more sensitive than was IC testing, taking RT-PCR analy- sis as the gold standard. Rectal swab or bulk stool specimens may be adequate for the detection of norovirus antigen when the EV-kit is used. [Original].

新型全自动实时逆转录聚合酶链反应试剂盒检测诺如病毒的性能评价
目的:快速、准确地检测诺如病毒对预防和控制疫情至关重要。本研究以单管逆转录-聚合酶链反应(RT-PCR)为金标准,比较全自动实时逆转录-聚合酶链反应法(EV-kit)与常规免疫层析法(IC)诊断诺如病毒的效果。方法:收集2013年11月至2014年3月在中山大学附属医院综合内科就诊的94例急性腹泻患者的临床资料和粪便标本(大便53例,直肠拭子41例)。通过与RT-PCR的比较确定各研究试验的敏感性和特异性,并通过测定Cohen’s kappa系数分析重复性。结果:94份标本中,35份(37%)经RT-PCR检测为诺如病毒抗原阳性,26份为散装粪便,9份为直肠拭子。EV-kit的敏感性为91%(32/35),特异性为88% (52/59),Cohen’s kappa系数为0.778;IC组分别为54%(19/35)、90%(53/59)和0.468。直肠拭子检测中,EV-kit的灵敏度为89% (8/9),IC的灵敏度为33%(3/9),大大便检测中EV-kit的灵敏度为92% (24/26),IC的灵敏度为62%(16/26)。结论:以RT-PCR分析为金标准,EV-kit的使用明显高于IC检测。当使用EV-kit时,直肠拭子或大块粪便标本可能足以检测诺如病毒抗原。(最初的)。
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