Ann Lab Med.  2014 May;34(3):216-222. 10.3343/alm.2014.34.3.216.

Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples

• Kim J
• Kim HS
• Kim HS
• Kim JS
• Song W
• Lee KM
• Lee S
• Park KU
• Lee W
• Hong YJ

• KMID: 1791923
• DOI: http://doi.org/10.3343/alm.2014.34.3.216

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 immunochromatographic assay (ICA), for the simultaneous detection of rotaviruses and adenoviruses 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 fluorescent 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 detection limit, reproducibility, cross-reactivity, and analytical reactivity for adenovirus subtypes, 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 agreement, and negative agreement rates of the ICA were 95.6%, 100%, and 94.9% for rotavirus, and 94.0%, 71.4%, and 94.8% for adenovirus, respectively. Using the ICA, we detected all the subtypes of adenovirus tested, but the analytical reactivities for adenovirus subtypes were different between the 4 adenovirus detection methods. The high reproducibility 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.

Keyword

Rotavirus; Immunochromatographic assay; ELISA; PCR

MeSH Terms

Acute Disease
Adenoviridae/genetics/*immunology/isolation & purification
Cross Reactions
DNA, Viral/analysis
Enzyme-Linked Immunosorbent Assay
Feces/*virology
Gastroenteritis/diagnosis/virology
Humans
*Immunochromatography
Multiplex Polymerase Chain Reaction
RNA, Viral/analysis
Reagent Kits, Diagnostic
Reproducibility of Results
Reverse Transcriptase Polymerase Chain Reaction
Rotavirus/genetics/*immunology/isolation & purification
DNA, Viral
RNA, Viral
Reagent Kits, Diagnostic

Reference

1. Barnes GL, Uren E, Stevens KB, Bishop RF. Etiology of acute gastroenteritis in hospitalized children in Melbourne, Australia, from April 1980 to March 1993. J Clin Microbiol. 1998; 36:133–138. PMID: 9431936.

2. Bon F, Fascia P, Dauvergne M, Tenenbaum D, Planson H, Petion AM, et al. 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. 1999; 37:3055–3058. PMID: 10449507.

3. Versalovic J, Carroll KC, editors. Manual of clinical microbiology. 10th ed. Washington, D.C: American Society of Microbiology Publishing;2011. p. 1456–1469.

4. Brown M, Grydsuk JD, Fortsas E, Petric M. Structural features unique to enteric adenoviruses. Arch Virol Suppl. 1996; 12:301–307. PMID: 9015127.

5. Versalovic J, Carroll KC, editors. Manual of clinical microbiology. 10th ed. Washington, D.C: American Society of Microbiology Publishing;2011. p. 1600–1611.

6. Wigand R. Pitfalls in the identification of adenoviruses. J Virol Methods. 1987; 16:161–169. PMID: 2821047.

7. Huh JW, Kim WH, Moon SG, Lee JB, Lim YH. Viral etiology andincidence associated with acute gastroenteritis a 5-year survey in Gyeonggi province, South Korea. J Clin Virol. 2009; 44:152–156. PMID: 19131274.

8. Min JH, Seo JW, Park HK. Detection of viral antigens in stool using EIA in hospitalized children and clinical implication. Korean J Pediatr Gastroenterol Nutr. 2004; 7:143–152.

9. Lee SY, Hong JH, Lee SW, Lee M. Comparisons of latex agglutination, immunechromatography and enzyme immunoassay methods for the detection of rotavirus antigen. Korean J Lab Med. 2007; 27:437–441. PMID: 18160834.

10. Higgins RR, Beniprashad M, Cardona M, Masney S, Low DE, Gubbay JB. 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. 2011; 49:3154–3162. PMID: 21775550.

11. Lee S, Park YJ, Lee HK, Kim SY, Kim JY, Lee SY, et al. Detection of 13 enteric bacteria and 5 viruses causing acute infectious diarrhea using multiplex PCR from direct stool specimens. Ann Clin Microbiol. 2013; 16:33–38.

12. Miller S, Liverman CS, Post L, Khan Y, Wright C. 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. 2012; 55:310–316. PMID: 22975084.

13. Tran A, Talmud D, Lejeune B, Jovenin N, Renois F, Payan C, et al. Prevalence of rotavirus, adenovirus, norovirus, and astrovirus infections and coinfections among hospitalized children in northern France. J Clin Microbiol. 2010; 48:1943–1946. PMID: 20305010.

14. Fang ZY, Yang H, Qi J, Zhang J, Sun LW, Tang JY, et al. Diversity of rotavirus strains among children with acute diarrhea in China: 1998-2000 surveillance study. J Clin Microbiol. 2002; 40:1875–1878. PMID: 11980983.

15. Konno T, Suzuki H, Katsushima N, Imai A, Tazawa F, Kutsuzawa T, et al. Influence of temperature and relative humidity on human rotavirus infection in Japan. J Infect Dis. 1983; 147:125–128. PMID: 6822748.

16. Dey SK, Hoq I, Okitsu S, Hayakawa S, Ushijima H. Prevalence, seasonality, and peak age of infection of enteric adenoviruses in Japan, 1995-2009. Epidemiol Infect. 2013; 141:958–960. PMID: 22813461.

17. Weitzel T, Reither K, Mockenhaupt FP, Stark K, Ignatius R, Saad E, et al. Field evaluation of a rota- and adenovirus immunochromatographic assay using stool samples from children with acute diarrhea in Ghana. J Clin Microbiol. 2007; 45:2695–2697. PMID: 17596373.

18. Knipe DM, Howley PM, editors. Fields virology. 4th ed. Philadelphia: Lippincott Williams & Wilkins Publishing;2001. p. 1787–1883.