Ann Lab Med.  2012 Jan;32(1):79-81. 10.3343/alm.2012.32.1.79.

Evaluation of a New Immunochromatographic Assay Kit for the Rapid Detection of Norovirus in Fecal Specimens

Affiliations
  • 1Chungcheongnam-Do Health and Environment Research Institute, Daejeon, Korea.
  • 2Daejeon Health and Environment Research Institute, Daejeon, Korea.
  • 3Department of Pediatrics, College of Medicine, Soonchunhyang University, Cheonan, Korea.
  • 4Department of Clinical Parasitology and Allergy, College of Medicine, Soonchunhyang University, Cheonan, Korea.
  • 5Department of Biochemistry, College of Medicine, Soonchunhyang University, Cheonan, Korea.
  • 6Department of Laboratory Medicine, College of Medicine, Soonchunhyang University, Cheonan, Korea. clinpath@sch.ac.kr

Abstract

Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. This study compared the effectiveness of a new immunochromatographic assay kit (SD BIOLINE Norovirus; Standard Diagnostics, Korea) and real-time reverse transcription-PCR (RT-PCR) for detecting norovirus in fecal specimens. Compared with real-time RT-PCR, the new assay had sensitivity, specificity, positive predictive value, and negative predictive value of 76.5% (52/68), 99.7% (342/343), 98.1% (52/53), and 95.5% (342/358), respectively. The sensitivity of the assay was 81.8% (18/22) for GII.3 and 75.7% (28/37) for GII.4. None of the 38 enteric virus-positive specimens (3 for astrovirus, 5 for enteric adenovirus, and 30 for rotavirus) tested positive in the cross-reactivity test performed by using this assay. The new immunochromatographic assay may be a useful screening tool for the rapid detection of norovirus in sporadic and outbreak cases; however, negative results may require confirmatory assays of greater sensitivity.

Keyword

Immunochromatographic assay; Norovirus; Sensitivity; Specificity

MeSH Terms

Acute Disease
Adolescent
Adult
Aged
Aged, 80 and over
Caliciviridae Infections/*diagnosis
Child
Child, Preschool
Feces/*virology
Gastroenteritis/*diagnosis/virology
Humans
*Immunoassay
Infant
Middle Aged
Norovirus/*genetics/isolation & purification
RNA, Viral/analysis
Reagent Kits, Diagnostic
Reverse Transcriptase Polymerase Chain Reaction
Sensitivity and Specificity

Reference

1. Costantini V, Grenz L, Fritzinger A, Lewis D, Biggs C, Hale A, et al. Diagnostic accuracy and analytical sensitivity of IDEIA Norovirus assay for routine screening of human norovirus. J Clin Microbiol. 2010. 48:2770–2778.
Article
2. Green KY. Knipe DM, Howley PM, editors. Caliciviridae: The Noroviruses. Fields virology. 2007. 5th ed. Philadelphia: Lippincott Williams and Wilkins;949–979.
3. Dolin R. Noroviruses - challenges to control. N Engl J Med. 2007. 357:1072–1073.
Article
4. Patel MM, Hall AJ, Vinjé J, Parashar UD. Noroviruses: a comprehensive review. J Clin Virol. 2009. 44:1–8.
Article
5. Boga JA, Melón S, Nicieza I, De Diego I, Villar M, Parra F, et al. Etiology of sporadic cases of pediatric acute gastroenteritis in asturias, Spain, and genotyping and characterization of norovirus strains involved. J Clin Microbiol. 2004. 42:2668–2674.
Article
6. Park KS, Jeong HS, Baek KA, Lee CG, Park SM, Park JS, et al. Genetic analysis of norovirus GII.4 variants circulating in Korea in 2008. Arch Virol. 2010. 155:635–641.
Article
7. Gray JJ, Kohli E, Ruggeri FM, Vennema H, Sánchez-Fauquier A, Schreier E, et al. European multicenter evaluation of commercial enzyme immunoassays for detecting norovirus antigen in fecal samples. Clin Vaccine Immunol. 2007. 14:1349–1355.
Article
8. Khamrin P, Nguyen TA, Phan TG, Satou K, Masuoka Y, Okitsu S, et al. Evaluation of immunochromatography and commercial enzyme-linked immunosorbent assay for rapid detection of norovirus antigen in stool samples. J Virol Methods. 2008. 147:360–363.
Article
9. Bruins MJ, Wolfhagen MJ, Schirm J, Ruijs GJ. Evaluation of a rapid immunochromatographic test for the detection of norovirus in stool samples. Eur J Clin Microbiol Infect Dis. 2010. 29:741–743.
Article
10. Derrington P, Schreiber F, Day S, Curtis C, Lyon M. Norovirus Ridaquick: a new test for rapid diagnosis of norovirus. Pathology. 2009. 41:687–688.
Article
11. Kirby A, Gurgel RQ, Dove W, Vieira SC, Cunliffe NA, Cuevas LE. An evaluation of the RIDASCREEN and IDEIA enzyme immunoassays and the RIDAQUICK immunochromatographic test for the detection of norovirus in faecal specimens. J Clin Virol. 2010. 49:254–257.
Article
12. Bruggink LD, Witlox KJ, Sameer R, Catton MG, Marshall JA. Evaluation of the RIDA(®)QUICK immunochromatographic norovirus detection assay using specimens from Australian gastroenteritis incidents. J Virol Methods. 2011. 173:121–126.
Article
13. Takanashi S, Okame M, Shiota T, Takagi M, Yagyu F, Tung PG, et al. Development of a rapid immunochromatographic test for noroviruses genogroups I and II. J Virol Methods. 2008. 148:1–8.
Article
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