Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Background: The Automated Fluorescent Immunoassay System (AFIAS) rotavirus assay (Boditech Med Inc., Chuncheon, Korea) is a new rapid antigen test for rotavirus detection. We evaluated the performance of this assay for detecting rotaviruses and their specific genotypes in clinical stool samples. Methods: AFIAS rotavirus assay was performed in 103 rotavirus-positive and 103 rotavirus-negative stool samples (confirmed by both PCR and ELISA), and its results were compared with those of PCR, ELISA, and immunochromatographic assay (ICA). We evaluated diagnostic sensitivity/specificity, the detectability of rotavirus subtypes, lower limit of detection (LLOD), reproducibility, cross-reactivity, and interference of AFIAS rotavirus assay. Results: Based on PCR and ELISA results, diagnostic sensitivity and specificity of the AFIAS rotavirus assay were both 99.0%. LLOD results showed that the AFIAS assay had sensitivity similar to or greater than ICA and ELISA. High reproducibility was confirmed, and no cross-reactivity or interference was detected. This assay could detect genotypes G1P[8], G2P[4], G3P[8], G4P[6], G4P[8], G8P[4], G8P[8], G9P[4], and G9P[8]. Conclusions: The AFIAS rotavirus assay showed high reproducibility, sensitivity, and specificity as well as excellent agreement with ELISA, PCR, and ICA. It detected the most common as well as unusual genotypes of rotavirus prevalent in Korea. It could be a useful on-site assay for rapid, convenient, and cost-effective detection of rotavirus infection.
Abstract
Background: The Automated Fluorescent Immunoassay System (AFIAS) rotavirus assay (Boditech Med Inc., Chuncheon, Korea) is a new rapid antigen test for rotavirus detection. We evaluated the performance of this assay for detecting rotaviruses and their specific genotypes in clinical stool samples. Methods: AFIAS rotavirus assay was performed in 103 rotavirus-positive and 103 rotavirus-negative stool samples (confirmed by both PCR and ELISA), and its results were compared with those of PCR, ELISA, and immunochromatographic assay (ICA). We evaluated diagnostic sensitivity/specificity, the detectability of rotavirus subtypes, lower limit of detection (LLOD), reproducibility, cross-reactivity, and interference of AFIAS rotavirus assay. Results: Based on PCR and ELISA results, diagnostic sensitivity and specificity of the AFIAS rotavirus assay were both 99.0%. LLOD results showed that the AFIAS assay had sensitivity similar to or greater than ICA and ELISA. High reproducibility was confirmed, and no cross-reactivity or interference was detected. This assay could detect genotypes G1P[8], G2P[4], G3P[8], G4P[6], G4P[8], G8P[4], G8P[8], G9P[4], and G9P[8]. Conclusions: The AFIAS rotavirus assay showed high reproducibility, sensitivity, and specificity as well as excellent agreement with ELISA, PCR, and ICA. It detected the most common as well as unusual genotypes of rotavirus prevalent in Korea. It could be a useful on-site assay for rapid, convenient, and cost-effective detection of rotavirus infection.
참고문헌 (16)
- Desselberger U, "Rotaviruses", Virus Res, 190, pp.75~96 (2014)
- Kim JS, "Analysis of rotavirus genotypes in Korea during 2013 : an increase in the G2P genotype after the introduction of rotavirus vaccines", Vaccine, 32, pp.6396~6402 (2014)
- Tate JE, "Global, regional, and national estimates of rotavirus mortality in children < 5 years of age, 2000-2013", Clin Infect Dis, 62, pp.S96~ (2016)[DOI]
- Miño S, "Comparison of two commercial kits and an in-house ELISA for the detection of equine rotavirus in foal feces", J Virol Methods, 222, pp.1~10 (2015)
- Fleming FE, "Rotavirus-neutralizing antibodies inhibit virus binding to integrins alpha 2 beta 1 and alpha 4 beta 1", Arch Virol, 152, pp.1087~1101 (2007)
- Jalilvand S, "Rotavirus VP6 preparations as a non-replicating vaccine candidates", Vaccine, 33, pp.3281~3287 (2015)
- 류지형, "Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C", Annals of Laboratory Medicine, 38(6), pp.578~584 (2018), 대한진단검사의학회
- 김자영, "Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples", Annals of Laboratory Medicine, 34(3), pp.216~222 (2014), 대한진단검사의학회
- Kim HS, "Discrepancies between antigen and polymerase chain reaction tests for the detection of rotavirus and norovirus", Ann Clin Lab Sci, 46, pp.282~285 (2016)
- Tate JE, "Comparison of 2 assays for diagnosing rotavirus and evaluating vaccine effectiveness in children with gastroenteritis", Emerg Infect Dis, 19, pp.1245~1252 (2013)
- Ye S, "Evidence of false-positive results in a commercially available rotavirus assay in the vaccine era, Australia, 2011-2012", Euro Surveill, 18, pp.20483~ (2013)
- Gautam R, "Comparison of Premier™ Rotaclone®, ProSpecT™, and RIDASCREEN® rotavirus enzyme immunoassay kits for detection of rotavirus antigen in stool specimens", J Clin Virol, 58, pp.292~294 (2013)
- Ye S, "Comparison of test specificities of commercial antigen-based assays and in-house PCR methods for detection of rotavirus in stool specimens", J Clin Microbiol, 53, pp.295~297 (2015)
- Weinberg GA, "First reports of human rotavirus G8P gastroenteritis in the United States", J Clin Microbiol, 50, pp.1118~1121 (2012)
- Ianiro G, "Molecular characterization of human G8P rotavirus strains in Italy : proposal of a more complete subclassification of the G8 genotype in three major lineages", Infect Genet Evol, 21, pp.129~133 (2014)
- "Bioanalytical method validation: guidance for industry" (2018)[URL]