Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples
2
조회
0
다운로드
7
인용
0
참고문헌
키워드
초록
Background: We evaluated the analytical and clinical performances of the SD BIOLINE Rota/Adeno Rapid kit (SD Rota/Adeno Rapid; Standard Diagnostics, Inc., Korea), an im- munochromatographic assay (ICA), for the simultaneous detection of rotaviruses and ade- noviruses in human stool samples. Methods: We tested 400 clinical stool samples from patients with acute gastroenteritis and compared the ICA results with the results obtained by using ELISA, enzyme-linked fluores- cent assays (ELFA), PCR, and multiplex reverse transcription-PCR (mRT-PCR). To assess the analytical performance of the SD BIOLINE Rota/Adeno Rapid kit, we determined its de- tection limit, reproducibility, cross-reactivity, and analytical reactivity for adenovirus sub- types, and performed interference studies. Results: The overall agreement rates among the tested methods were 91.5% for rotavirus and 85.5% for adenovirus. On the basis of mRT-PCR, the overall agreement, positive agree- ment, and negative agreement rates of the ICA were 95.6%, 100%, and 94.9% for rotavi- rus, and 94.0%, 71.4%, and 94.8% for adenovirus, respectively. Using the ICA, we de- tected all the subtypes of adenovirus tested, but the analytical reactivities for adenovirus subtypes were different between the 4 adenovirus detection methods. The high reproduc- ibility was confirmed, and no cross-reactivity or interference was detected. Conclusions: The SD BIOLINE Rota/Adeno Rapid kit showed acceptable analytical and clinical performances. However, interpretation of adenovirus positive/negative result should be cautious because of different detectability for adenovirus subtypes among adenovirus detection methods.
Abstract
Background: We evaluated the analytical and clinical performances of the SD BIOLINE Rota/Adeno Rapid kit (SD Rota/Adeno Rapid; Standard Diagnostics, Inc., Korea), an im- munochromatographic assay (ICA), for the simultaneous detection of rotaviruses and ade- noviruses in human stool samples. Methods: We tested 400 clinical stool samples from patients with acute gastroenteritis and compared the ICA results with the results obtained by using ELISA, enzyme-linked fluores- cent assays (ELFA), PCR, and multiplex reverse transcription-PCR (mRT-PCR). To assess the analytical performance of the SD BIOLINE Rota/Adeno Rapid kit, we determined its de- tection limit, reproducibility, cross-reactivity, and analytical reactivity for adenovirus sub- types, and performed interference studies. Results: The overall agreement rates among the tested methods were 91.5% for rotavirus and 85.5% for adenovirus. On the basis of mRT-PCR, the overall agreement, positive agree- ment, and negative agreement rates of the ICA were 95.6%, 100%, and 94.9% for rotavi- rus, and 94.0%, 71.4%, and 94.8% for adenovirus, respectively. Using the ICA, we de- tected all the subtypes of adenovirus tested, but the analytical reactivities for adenovirus subtypes were different between the 4 adenovirus detection methods. The high reproduc- ibility was confirmed, and no cross-reactivity or interference was detected. Conclusions: The SD BIOLINE Rota/Adeno Rapid kit showed acceptable analytical and clinical performances. However, interpretation of adenovirus positive/negative result should be cautious because of different detectability for adenovirus subtypes among adenovirus detection methods.
참고문헌 (18)
- Barnes GL, "Etiology of acute gastroenteritis in hospitalized children in Melbourne, Australia, from April 1980 to March 1993", J Clin Microbiol, 36, pp.133~138 (1998)
- Bon F, "Prevalence of group A rotavirus, human calicivirus, astrovirus, and adenovirus type 40 and 41 infections among children with acute gastroenteritis in Dijon, France", J Clin Microbiol, 37, pp.3055~3058 (1999)
- Versalovic J, "Manual of clinical microbiology. 10th ed", pp.1456~1469 (2011), American Society of Microbiology Publishing
- Brown M, "Structural features unique to enteric adenoviruses", Arch Virol Suppl, 12, pp.301~307 (1996)
- Versalovic J, "Manual of clinical microbiology, 10th ed", pp.1600~1611 (2011), American Society of Microbiology Publishing
- Wigand R, "Pitfalls in the identification of adenoviruses", J Virol Methods, 16, pp.161~169 (1987)
- Huh JW, "Viral etiology andincidence associated with acute gastroenteritis a 5-year survey in Gyeonggi province, South Korea", J Clin Virol, 44, pp.152~156 (2009)
- 민정혜, "간접 효소 면역측정법을 이용한 입원 환아의 대변에서 바이러스 항원의 검출과 임상적 의의", Pediatric Gastroenterology, Hepatology & Nutrition, 7(2), pp.143~152 (2004), 대한소아소화기영양학회
- 이숙영, "로타바이러스 항원 검출을 위한 라텍스응집법, 면역크로마토그래피법 및 효소면역법의 비교", Annals of Laboratory Medicine, 27(6), pp.437~441 (2007), 대한진단검사의학회
- Higgins RR, "Evaluation and verification of the Seeplex Diarrhea-V ACE assay for simultaneous detection of adenovirus, rotavirus, and norovirus genogroups I and II in clinical stool specimens", J Clin Microbiol, 49, pp.3154~3162 (2011)
- 이승옥, "다중 중합효소연쇄반응법을 이용한 급성 감염성 설사의 원인세균 13종 및 바이러스 5종 검출", Annals of Clinical Microbiology, 16(1), pp.33~38 (2013), 대한임상미생물학회
- Miller S, "Analytical and clinical performance characteristics of the Simplexa BK virus quantitative PCR assay for the diagnosis of polyomavirus-associated nephropathy in renal transplant recipients using plasma and urine specimens", J Clin Virol, 55, pp.310~316 (2012)
- Tran A, "Prevalence of rotavirus, adenovirus, norovirus, and astrovirus infections and coinfections among hospitalized children in northern France", J Clin Microbiol, 48, pp.1943~1946 (2010)
- Fang ZY, "Diversity of rotavirus strains among children with acute diarrhea in China: 1998-2000 surveillance study", J Clin Microbiol, 40, pp.1875~1878 (2002)
- Konno T, "Influence of temperature and relative humidity on human rotavirus infection in Japan", J Infect Dis, 147, pp.125~128 (1983)
- Dey SK, "Prevalence, seasonality, and peak age of infection of enteric adenoviruses in Japan, 1995-2009", Epidemiol Infect, 141, pp.958~960 (2013)
- Weitzel T, "Field evaluation of a rota- and adenovirus immunochromatographic assay using stool samples from children with acute diarrhea in Ghana", J Clin Microbiol, 45, pp.2695~2697 (2007)
- Knipe DM, "Fields virology, 4th ed", pp.1787~1833 (2001), Lippincott Williams & Wilkins Publishing