Evaluation of Performance Among Norovirus Antigen Detection Kits with Immunochromatography

Yuki Sato, M. Shinagawa, Yusuke Takahashi, Masachika Saeki, Yuki Yakuwa, S. Takahashi
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Abstract

We have evaluated the performance among four brands of immunochromatography (IC) assay kits, available in the market in Japan, for detection of norovirus antigen and compared with Real Time PCR (RT-PCR) assays. The four brands used were ImmunoCatch-Noro (A Kit, EIKEN CHEMICAL Co., Ltd., Japan), Quick Chaser-Noro (B Kit, MIZUHO MEDY Co., Ltd., Saga, Japan), GE test Noro Nissui (C Kit, NISSUI PHARMACEUTICAL Co., Ltd., Tokyo, Japan), and Quick Navi-Noro2 (D Kit, DENKA SEIKEN Co., Ltd., Tokyo, Japan). The results from the RT-PCR analysis of 69 suspected cases of norovirus infection identified 6 cases of Genogroup I (GI) and 22 cases of Genogroup II (GII) infection, whereas one case among them had a mixed infection of both GI and GII. The virus titers of the positive samples varied from 1.54×10 1 to 3.14× 10 8 copies/ μ L. The genotypes identified were as follows:GI, GI.1 (1 case each), GI.2 (3 cases), and GI.3 (2 cases);GII, GII.2 (1 case each), GII.4 (7 cases), GII.13 (2 cases), and GII.17 (12 cases). The positive concordance rates between the IC assay kits and the Real Time RT-PCR were as follows:A, 59.3 % ;B, 51.9 % ;C, 51.9 % ;and
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免疫层析法检测诺如病毒抗原试剂盒的性能评价
我们评估了日本市场上四种品牌的免疫层析(IC)检测试剂盒检测诺如病毒抗原的性能,并与实时PCR (RT-PCR)检测方法进行了比较。使用的四个品牌分别是immunocapture -Noro (A试剂盒,EIKEN CHEMICAL Co., Ltd.,日本)、Quick Chaser-Noro (B试剂盒,MIZUHO medicine Co., Ltd., Saga,日本)、GE test Noro Nissui (C试剂盒,Nissui PHARMACEUTICAL Co., Ltd.,日本东京)和Quick Navi-Noro2 (D试剂盒,DENKA SEIKEN Co., Ltd.,日本东京)。对69例诺如病毒疑似感染病例进行RT-PCR分析,鉴定为基因I型(GI)感染6例,基因II型(GII)感染22例,其中1例为GI和GII混合感染。阳性标本的病毒滴度为1.54×10 1 ~ 3.14× 10 8拷贝/ μ l,鉴定的基因型为GI、GI.1(各1例)、GI.2(3例)和GI.3(2例);GII、GII.2(各1例)、GII.4(7例)、GII.13(2例)和GII.17(12例)。IC试剂盒与Real Time RT-PCR的阳性符合率分别为:A, 59.3%;B, 51.9%;C, 51.9%
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