Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples

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.

[1]  Yonggoo Kim,et al.  Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C , 2018, Annals of laboratory medicine.

[2]  H. S. Kim,et al.  Discrepancies between Antigen and Polymerase Chain Reaction Tests for the Detection of Rotavirus and Norovirus. , 2016, Annals of clinical and laboratory science.

[3]  J. Tate,et al.  Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000-2013. , 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  M. Barrandeguy,et al.  Comparison of two commercial kits and an in-house ELISA for the detection of equine rotavirus in foal feces. , 2015, Journal of virological methods.

[5]  S. Marashi,et al.  Rotavirus VP6 preparations as a non-replicating vaccine candidates. , 2015, Vaccine.

[6]  Wonkeun Song,et al.  Analysis of rotavirus genotypes in Korea during 2013: an increase in the G2P[4] genotype after the introduction of rotavirus vaccines. , 2014, Vaccine.

[7]  S. Lambert,et al.  Comparison of Test Specificities of Commercial Antigen-Based Assays and In-House PCR Methods for Detection of Rotavirus in Stool Specimens , 2014, Journal of Clinical Microbiology.

[8]  Woochang Lee,et al.  Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples , 2014, Annals of laboratory medicine.

[9]  O. Quaye,et al.  Comparison of Premier™ Rotaclone®, ProSpecT™, and RIDASCREEN® rotavirus enzyme immunoassay kits for detection of rotavirus antigen in stool specimens. , 2013, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[10]  J. Tate,et al.  Comparison of 2 Assays for Diagnosing Rotavirus and Evaluating Vaccine Effectiveness in Children with Gastroenteritis , 2013, Emerging infectious diseases.

[11]  J. Robson,et al.  Evidence of false-positive results in a commercially available rotavirus assay in the vaccine era, Australia, 2011 to 2012. , 2013, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[12]  U. Parashar,et al.  First Reports of Human Rotavirus G8P[4] Gastroenteritis in the United States , 2011, Journal of Clinical Microbiology.

[13]  Y. Takada,et al.  Rotavirus-neutralizing antibodies inhibit virus binding to integrins α2β1 and α4β1 , 2007, Archives of Virology.

[14]  Pamela G. Guren,et al.  Candidates , 1982, Otolaryngology–Head and Neck Surgery.

[15]  F. Ruggeri,et al.  Molecular characterization of human G8P[4] rotavirus strains in Italy: proposal of a more complete subclassification of the G8 genotype in three major lineages. , 2014, Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases.

[16]  Y. Takada,et al.  Rotavirus-neutralizing antibodies inhibit virus binding to integrins alpha 2 beta 1 and alpha 4 beta 1. , 2007, Archives of virology.