title: Evaluation of an immunochromatographic assay for the rapid and simultaneous detection of rotavirus and adenovirus in stool samples.
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.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jayoung
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Hyun Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Han-Sung
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Jae-Seok
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Wonkeun
authors.initials: W
authors.lastname: Song
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Kyu Man
authors.initials: KM
authors.lastname: Lee
authors.affiliation: Seegene Medical Foundation, Seoul, Korea.
authors.forename: Sunhwa
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Kyoung Un
authors.initials: KU
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Woochang
authors.initials: W
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, Korea Cancer Center Hospital, Seoul, Korea.
authors.forename: Young Jun
authors.initials: YJ
authors.lastname: Hong
mesh_terms: D000208:Acute Disease; D000256:Adenoviridae / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D002846:Chromatography, Affinity; D003429:Cross Reactions; D004279:DNA, Viral / Q000032:analysis; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000821:virology*; D005759:Gastroenteritis / Q000175:diagnosis / Q000821:virology; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012401:Rotavirus / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: ELISA; Immunochromatographic assay; PCR; Rotavirus