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The Journal of the Japanese Society for Clinical Microbiology |
Biblioraphy Information
ArticleTitle |
Clinical evaluation of immunochromatography and PCR for Norovirus Utility of immunochromatography for Norovirus detection |
Language |
J |
AuthorList |
Ayako Hisada1), Keiki Nagaharu2), Syuji Yamamoto3), Hajime Kusuhara4), Manami Negoro5), Kiyoshi Taniguchi5), Kenichiro Hoshino3), Kiyomi Nakamura1) |
Affiliation |
1) Department of Clinical Laboratory, Medical Corporation Principal Association OYAMADA Memorial Hot Spring Hospital
2) Department of Hematology, Mie University Hospital
3) Department of Internal Medicine, Medical Corporation Principal Association OYAMADA Memorial Hot Spring Hospital
4) Department of Hygine, Microbiology Course, Mie Institute of Health and Environment
5) Department of Clinical Research, National Hospital Organization Mie Hospital |
Publication |
J.J.C.M.: 32 (4), 224-228, 2022 |
Received |
March 31, 2022 |
Accepted |
May 16, 2022 |
Abstract |
The clinical utility of immunochromatography (IC) for norovirus detection has been established. However, the sensitivity and specificity of IC for norovirus depends on the viral load and/or the viral genotype. Herein, we prospectively validated the clinical application of IC for norovirus diagnosis and explore the factors affecting the accuracy of this method. After informed consent, we evaluated fecal samples by both IC and real-time polymerase chain reaction (PCR) for norovirus-suspected patients. The corresponding detection rates were compared between these two methods. Furthermore, we investigated the impact on the IC results of viral load, genotype, time from clinical onset and symptom. During January 2016 and March 2018, 263 patients were enrolled. The positive/negative predictive rates of the IC method compared with PCR were 58.1% and 100%, respectively. The estimated viral titer of IC-positive patients was significantly higher than that of IC-negative patients. The false negative rate of the IC method (PCR positive but IC negative) gradually increased as viral titer decreased. The positive predictive values of GII.4 Sydney2012 (n=82) and GII.2 (n=19) were 61.0% and 52.6%, respectively. The positive predictive value of IC increased along with time from the onset of clinical symptoms. By contrast, analysis by symptom revealed no difference in the positive predictive value of the IC method. The sensitivity of the IC method was negatively affected by low RNA levels of norovirus and was also influenced by the strain of virus. Clinicians should consider PCR-based evaluation even if IC indicates a negative sample. |
Keywords |
norovirus, immunochromatography, real-time polymerase chain reaction, genotype, sensitivity |
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