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Background: Sweat chloride test is the gold standard test for cystic fibrosis (CF) diagnosis. In 2014 the Istituto Superiore di Sanità (ISS) established the first Italian pilot external quality assessment (EQA) program for CF sweat chloride test. In 2015 this activity was recognized as a third party service carried out by the ISS. The present paper describes the results of the first official 2015 sweat chloride test EQA program and results are compared with the 2014 round ones. Methods: the scheme is prospective; participation is open to Italian laboratories performing sweat test analysis for CF diagnosis. Enrollment is voluntary and since 2015 the payment of a fee is required. Participants are registered identified by an identification number known only to the ISS. Assessment covers analysis, interpretation and reporting. Results: thirteen laboratories, belonging to the Italian public Referral Centers for CF, participated in the 2015 round; nine already participated in 2014. Variability in scores of chloride titration and heterogeneity in interpretation / reporting results were identified in 2014 and 2015. Conclusions: results show variability in performance of laboratories indicating that the quality of laboratory performance is unpredictable unless EQA participation is mandatory as a component of compulsory laboratory accreditation..

The Italian External Quality Assessment Program for CF Sweat Chloride Test: Results of the 2015 Round