title: Diagnostic performance of the Luminex xTAG gastrointestinal pathogens panel to detect rotavirus in Ghanaian children with and without diarrhoea.
abstract: BACKGROUND
  Rotavirus is one of the leading causes of childhood diarrhoea worldwide. The highest disease burden is seen in resource-constrained settings of sub-Saharan Africa. Recently, commercial multiplex PCR panels proved their accuracy to diagnose infectious gastroenteritis in Europe and the USA. However, data on their performance using samples from tropical regions in general and to detect rotavirus in particular remains scant. We aimed to analyse the diagnostic performance of the Luminex xTAG gastrointestinal pathogens panel, a multiplex PCR, to detect rotavirus in stool samples from Ghanaian children.
  
  
  METHODS
  A total of 682 stool samples were collected in the Ashanti region of Ghana between 2007 and 2008. Of these, 341 were from cases (children with diarrhoea), and another 341 from controls (children without diarrhoea). All samples were analysed using the Luminex xTAG assay and compared to a rotavirus quantitative reverse-transcription PCR (reference assay). Rotavirus reference assay positive samples were P and G genotyped by sequencing the rotavirus VP4 and VP7 genes.
  
  
  RESULTS
  Overall agreement between the Luminex xTAG and the reference assay was excellent (kappa 0.93). The sensitivity and specificity was 88.2 % (95 % confidence interval [CI] 78.2-94.1) and 100 % (95 % CI 99.2-100), respectively. Of 76 rotavirus reference assay positive samples, 64 were successfully genotyped and the Luminex xTAG assay was able to detect all rotavirus genotypes present in the study.
  
  
  CONCLUSIONS
  The Luminex xTAG assay proved a sensitive and highly specific tool to detect rotavirus and may aid clinicians and public health authorities in the diagnosis and surveillance of rotavirus.
authors.affiliation: Institute for Virology, Center for Microbiology and Hygiene, University Medical Center - Freiburg University, Hermann-Herder-Str. 11, 79104, Freiburg, Germany.
authors.forename: Amelie
authors.initials: A
authors.lastname: Leva
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Str. 74, 20359, Hamburg, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Eibach
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Str. 74, 20359, Hamburg, Germany.|German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck, Hamburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Krumkamp
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Str. 74, 20359, Hamburg, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Käsmaier
authors.affiliation: Institute for Virology, Center for Microbiology and Hygiene, University Medical Center - Freiburg University, Hermann-Herder-Str. 11, 79104, Freiburg, Germany.
authors.forename: Dennis
authors.initials: D
authors.lastname: Rubbenstroth
authors.affiliation: Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana.
authors.forename: Yaw
authors.initials: Y
authors.lastname: Adu-Sarkodie
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Str. 74, 20359, Hamburg, Germany.|German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck, Hamburg, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: May
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Str. 74, 20359, Hamburg, Germany.|German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck, Hamburg, Germany.
authors.forename: Egbert
authors.initials: E
authors.lastname: Tannich
authors.affiliation: Institute for Virology, Center for Microbiology and Hygiene, University Medical Center - Freiburg University, Hermann-Herder-Str. 11, 79104, Freiburg, Germany. marcus.panning@uniklinik-freiburg.de.
authors.forename: Marcus
authors.initials: M
authors.lastname: Panning
mesh_terms: D001419:Bacteria / Q000145:classification / Q000302:isolation & purification*; D001424:Bacterial Infections / Q000175:diagnosis / Q000382:microbiology*; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000175:diagnosis / Q000382:microbiology / Q000821:virology*; D005243:Feces / Q000382:microbiology / Q000821:virology; D005260:Female; D005869:Ghana; D006801:Humans; D007223:Infant; D008297:Male; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D012401:Rotavirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D012400:Rotavirus Infections / Q000175:diagnosis / Q000821:virology*; D012680:Sensitivity and Specificity
keywords: Luminex xTAG gastrotinestinal pathogens panel; Performance; Rotavirus; Stool samples; Sub-saharan Africa