title: The Italian pilot external quality assessment program for cystic fibrosis sweat test.
abstract: OBJECTIVE
  Sweat chloride test is the gold standard test for cystic fibrosis (CF) diagnosis. In 2014 the Istituto Superiore di Sanità established the Italian pilot external quality assessment program for CF sweat test (IEQA-ST).
  
  
  METHODS
  Ten laboratories, included among the 33 Italian CF Referral Centers, were selected and enrolled on the basis of their attitude to perform sweat test (ST) analysis by using methods recommended by the Italian Guidelines. They received three different sweat-like samples (normal, borderline and pathologic chloride concentration), with mock clinical indications, for analysis according to routine procedures. Assessment, performed by a panel of experts, covered analytical performance, interpretation and reporting of results; categories of "poor" and "satisfactory" performance were not defined. All data were managed through a web utility.
  
  
  RESULTS
  The program identified important areas of interest and, in some case, of concern. It is important to underline that results are referred to a small proportion, i.e. about 30%, of Italian laboratories performing CF ST in the context of the Referral Centers.
  
  
  CONCLUSIONS
  Data collected highlight the importance of participation in EQA programs as it may improve laboratory/clinical performance; our study represents a model for the setting up of a large-scale EQA scheme for ST.
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy. Electronic address: marco.salvatore@iss.it.
authors: Marco
authors: M
authors: Salvatore
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Giovanna
authors: G
authors: Floridia
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Annalisa
authors: A
authors: Amato
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Federica
authors: F
authors: Censi
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Claudio
authors: C
authors: Carta
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Maria Chiara
authors: MC
authors: de Stefano
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Gianluca
authors: G
authors: Ferrari
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Fabrizio
authors: F
authors: Tosto
authors: Laboratory of Clinical Molecular and Personalized Diagnostics, Policlinico Universitario A. Gemelli, Roma, Italy.
authors: Ettore
authors: E
authors: Capoluongo
authors: LABSIEM - Laboratory for the Study of Inborn Errors of Metabolism, Genoa University, DINOGMI, Genoa, Italy.
authors: Ubaldo
authors: U
authors: Caruso
authors: CEINGE - Advanced Biotechnology Scarl, Naples, Italy; Department of Molecular Medicine and Medical Biotechnology, University of Naples Federico II, Naples, Italy.
authors: Giuseppe
authors: G
authors: Castaldo
authors: Cystic Fibrosis Referral Care Center, Mother-Child Department, United Hospitals, Salesi Children's Hospital, Ancona, Italy.
authors: Natalia
authors: N
authors: Cirilli
authors: Regional Screening Centre, Istituti Clinici di Perfezionamento, Milan, Lombardia Region, Italy.
authors: Carlo
authors: C
authors: Corbetta
authors: Cystic Fibrosis Support Center, Paediatric Department, Children's Hospital, AO Spedali Civili, Brescia, Italy.
authors: Rita
authors: R
authors: Padoan
authors: Regional Cystic Fibrosis Center, Pediatric Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.
authors: Valeria
authors: V
authors: Raia
authors: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
authors: Domenica
authors: D
authors: Taruscio
mesh_terms: D002712:Chlorides / Q000032:analysis*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003550:Cystic Fibrosis / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine / Q000592:standards*; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D007753:Laboratories / Q000592:standards*; D010865:Pilot Projects; D011446:Prospective Studies; D011786:Quality Control; D012107:Research Design; D013542:Sweat / Q000737:chemistry*
chemical_list: D002712:Chlorides
keywords: CFTR gene; Chloride; Cystic fibrosis; EQA; Sweat test