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Evaluation of Performance Among Norovirus Antigen Detection Kits with Immunochromatography
1)Division of Laboratory Medicine, Sapporo Medical University Hospital, 2)Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine
Yuki SATO1), Masaaki SHINAGAWA1), Yusuke TAKAHASHI1), Masachika SAEKI1), Yuki YAKUWA1) & Satoshi TAKAHASHI1)2)
(Received August 17, 2017)
(Accepted November 14, 2017)
Key words: norovirus, real time RT-PCR, immunochromatography

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., Tokyo, 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 1.54×101 to 3.14×108 copies/μL. 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 D, 48.1%. On the other hand, the negative concordance rates were as follows: A, 97.6%; B, 100 %; C, 100%; and D, 97.6%. There was good agreement among the kits in norovirus detection as assessed with the κ coefficient. GII.P17_GII.17/Kawasaki308, known to be weakly-reactive for norovirus antigen assay kits, was detected in 12 cases; however, the samples with a virus titer of 104 to 105 copies/μL or less tended to test false-negative. The sensitivity of detection, which is a limitation of norovirus antigen assay kits, as well as the reaction specificity of the assay should be of consideration in the use of IC assay kits in the clinical environment.

[ Kansenshogaku Zasshi 92: 120-125, 2018 ]

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