Clinical Evaluation of Seeplex® Diarrhea‐V ACE Detection (V2.0) Kit for Detection of Rotavirus in Stool Specimens from Children with Acute Gastroenteritis

&NA; Rotavirus is the most common cause of severe infectious diarrhea worldwide in children under 5 years of age. We have evaluated the performance of multiplex PCR [Seeplex® Diarrhea‐V ACE Detection (V2.0) Kit] (the version 2.0 kit) for detecting rotaviruses in human stool specimens, in a comparison with ELISA (RIDASCREEN®) and the older Seeplex kit, namely Seeplex® Diarrhea‐V ACE Detection Kit (the original kit). A total of 173 stool specimens, previously tested for rotavirus infection by ELISA from May 2014 to March 2016, were subjected to the two Seeplex® kits. The positive rate for the detection of rotavirus was 46.2% (80/173) by the version 2.0 kit. As compared with ELISA, the agreement rate of the original kit and the version 2.0 kit was 64.2% (positive agreement rate 23.1%, negative agreement rate 97.9%) and 97.7% (positive agreement rate 98.7%, negative agreement rate 96.8%), respectively. The agreement rate between the original kit and the version 2.0 kit was 65.3%. Thus, the Seeplex® Diarrhea‐V ACE Detection (V2.0) Kit showed acceptable clinical performance and could be useful for detecting rotavirus infection with a performance superior to the original kit using the ELISA as the comparator.

[1]  L. Lamberti,et al.  A Systematic Review of the Effect of Rotavirus Vaccination on Diarrhea Outcomes Among Children Younger Than 5 Years , 2016, The Pediatric infectious disease journal.

[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]  Juwon Kim,et al.  Detection of Bacterial and Viral Pathogens in Stool Specimens Using Multiplex PCR , 2015 .

[5]  G. Kang,et al.  WHO Global Rotavirus Surveillance Network: A Strategic Review of the First 5 Years, 2008–2012 , 2014, MMWR. Morbidity and mortality weekly report.

[6]  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.

[7]  Jae Kyung Kim,et al.  Molecular Epidemiologic Trends of Diarrhea‐Causing Virus Infection From Clinical Specimens in Cheonan, Korea, in 2010–2012 , 2014, Journal of clinical laboratory analysis.

[8]  Hyun-So Kim,et al.  Evaluation of an Immunochromatographic Assay for the Detection of Rotavirus , 2013 .

[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]  Seungok Lee,et al.  Detection of 13 Enteric Bacteria and 5 Viruses Causing Acute Infectious Diarrhea Using Multiplex PCR from Direct Stool Specimens , 2013 .

[11]  U. Parashar,et al.  Systematic review of regional and temporal trends in global rotavirus strain diversity in the pre rotavirus vaccine era: insights for understanding the impact of rotavirus vaccination programs. , 2012, Vaccine.

[12]  D. Low,et al.  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 , 2011, Journal of Clinical Microbiology.

[13]  Jelle Matthijnssens,et al.  Uniformity of rotavirus strain nomenclature proposed by the Rotavirus Classification Working Group (RCWG) , 2011, Archives of Virology.

[14]  G. Barnes,et al.  Distribution of Rotavirus Genotypes After Introduction of Rotavirus Vaccines, Rotarix® and RotaTeq®, into the National Immunization Program of Australia , 2011, The Pediatric infectious disease journal.

[15]  J. Matthijnssens,et al.  Rotavirus incidence and genotype distribution before and after national rotavirus vaccine introduction in Belgium. , 2010, Vaccine.

[16]  N. Lévêque,et al.  Prevalence of Rotavirus, Adenovirus, Norovirus, and Astrovirus Infections and Coinfections among Hospitalized Children in Northern France , 2010, Journal of Clinical Microbiology.

[17]  Sun-Hee Kim,et al.  Distribution of Group A Rotavirus Genotypes Circulating in Gwangju, Korea , 2009 .

[18]  Jelle Matthijnssens,et al.  Recommendations for the classification of group A rotaviruses using all 11 genomic RNA segments , 2008, Archives of Virology.

[19]  Wonyong Kim,et al.  Detection of unusual rotavirus genotypes G8P[8] and G12P[6] in South Korea , 2008, Journal of medical virology.

[20]  Klaus Stark,et al.  Field Evaluation of a Rota- and Adenovirus Immunochromatographic Assay Using Stool Samples from Children with Acute Diarrhea in Ghana , 2007, Journal of Clinical Microbiology.

[21]  Sue-N. Park,et al.  Assessment of the quantitative real-time polymerase chain reaction using a cDNA standard for human group A rotavirus. , 2006, Journal of virological methods.

[22]  J. Bresee,et al.  Epidemiological profile of rotavirus infection in the Republic of Korea: results from prospective surveillance in the Jeongeub District, 1 July 2002 through 30 June 2004. , 2005, The Journal of infectious diseases.

[23]  R. Glass,et al.  Molecular epidemiological profile of rotavirus in South Korea, July 2002 through June 2003: emergence of G4P[6] and G9P[8] strains. , 2005, The Journal of infectious diseases.

[24]  S. Weber,et al.  Rotavirus infection in adults , 2004, The Lancet Infectious Diseases.

[25]  A. Sánchez-Fauquier,et al.  Viruses causing gastroenteritis , 2003, Clinical Microbiology and Infection.

[26]  A. Steele,et al.  Rotavirus strains circulating in Africa during 1996-1999: emergence of G9 strains and P[6] strains. , 2003, Vaccine.

[27]  R. Glass,et al.  Diversity of Rotavirus Strains among Children with Acute Diarrhea in China: 1998-2000 Surveillance Study , 2002, Journal of Clinical Microbiology.

[28]  C. Rao,et al.  Sequence analysis of VP4 and VP7 genes of nontypeable strains identifies a new pair of outer capsid proteins representing novel P and G genotypes in bovine rotaviruses. , 2000, Virology.

[29]  A. Rigby,et al.  Statistical methods in epidemiology. v. Towards an understanding of the kappa coefficient , 2000, Disability and rehabilitation.

[30]  R. Glass,et al.  Characterization of rotavirus strains from newborns in New Delhi, India , 1994, Journal of clinical microbiology.

[31]  Hon Keung Tony Ng,et al.  Statistical Methods in Epidemiology , 2011, International Encyclopedia of Statistical Science.

[32]  Y. Hoshino,et al.  Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine , 2005, Reviews in medical virology.