title: External quality assessment studies for laboratory performance of molecular and serological diagnosis of Chikungunya virus infection.
abstract: BACKGROUND
  Since the re-emergence of Chikungunya virus (CHIKV) in Reunion in 2005 and the recent outbreak in the Caribbean islands with an expansion to the Americas the CHIK diagnostic became very important.
  
  
  OBJECTIVE
  We evaluate the performance of laboratories regarding molecular and serological diagnostic of CHIK worldwide.
  
  
  METHODS
  A panel of 12 samples for molecular and 13 samples for serology were provided to 60 laboratories in 40 countries for evaluating the sensitivity and specificity of molecular and serology testing.
  
  
  RESULTS
  The panel for molecular diagnostic testing was analysed by 56 laboratories returning 60 data sets of results whereas the 56 and 60 data sets were returned for IgG and IgM diagnostic from the participating laboratories. Twenty-three from 60 data sets performed optimal, 7 acceptable and 30 sets of results require improvement. From 50 data sets only one laboratory shows an optimal performance for IgM detection, followed by 9 data sets with acceptable and the rest need for improvement. From 46 IgG serology data sets 20 provide an optimal, 2 an acceptable and 24 require improvement performance. The evaluation of some of the diagnostic performances allows linking the quality of results to the in-house methods or commercial assays used.
  
  
  CONCLUSIONS
  The external quality assurance for CHIK diagnostics provides a good overview on the laboratory performance regarding sensitivity and specificity for the molecular and serology diagnostic required for the quick and reliable analysis of suspected CHIK patients. Nearly half of the laboratories have to improve their diagnostic profile to achieve a better performance.
authors.affiliation: Centre for Biological Threats and Special Pathogens, Highly Pathogenic Viruses, Robert Koch Institute, Berlin, Germany.
authors.forename: Sonja
authors.initials: S
authors.lastname: Jacobsen
authors.affiliation: Centre for Biological Threats and Special Pathogens, Highly Pathogenic Viruses, Robert Koch Institute, Berlin, Germany.
authors.forename: Pranav
authors.initials: P
authors.lastname: Patel
authors.affiliation: WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.
authors.forename: Jonas
authors.initials: J
authors.lastname: Schmidt-Chanasit
authors.affiliation: Centre national de référence des arbovirus, Errit-IRBA HIA Laveran, Marseille, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Leparc-Goffart
authors.affiliation: Centre for Biological Threats and Special Pathogens, Highly Pathogenic Viruses, Robert Koch Institute, Berlin, Germany.
authors.forename: Anette
authors.initials: A
authors.lastname: Teichmann
authors.affiliation: European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden.
authors.forename: Herve
authors.initials: H
authors.lastname: Zeller
authors.affiliation: Centre for Biological Threats and Special Pathogens, Highly Pathogenic Viruses, Robert Koch Institute, Berlin, Germany. Electronic address: niedrigm@rki.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Niedrig
mesh_terms: D065632:Chikungunya Fever / Q000097:blood / Q000175:diagnosis*; D002646:Chikungunya virus / Q000302:isolation & purification; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011786:Quality Control; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000592:standards*; D014900:West Indies
keywords: CHIK; Chikungunya; Diagnosis; EQA; Molecular; Proficiency test; Quality control; Serology