TY - JOUR
T1 - The Italian pilot external quality assessment program for cystic fibrosis sweat test
AU - Salvatore, Marco
AU - Floridia, Giovanna
AU - Amato, Annalisa
AU - Censi, Federica
AU - Carta, Claudio
AU - de Stefano, Maria Chiara
AU - Ferrari, Gianluca
AU - Tosto, Fabrizio
AU - Capoluongo, Ettore
AU - Caruso, Ubaldo
AU - Castaldo, Giuseppe
AU - Cirilli, Natalia
AU - Corbetta, Carlo
AU - Padoan, Rita
AU - Raia, Valeria
AU - Taruscio, Domenica
PY - 2015/9/4
Y1 - 2015/9/4
N2 - Objectives: 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). Design and 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.
AB - Objectives: 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). Design and 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.
KW - CFTR gene
KW - Chloride
KW - Cystic fibrosis
KW - EQA
KW - Sweat test
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U2 - 10.1016/j.clinbiochem.2015.12.014
DO - 10.1016/j.clinbiochem.2015.12.014
M3 - Article
AN - SCOPUS:84957648193
JO - Clinical Biochemistry
JF - Clinical Biochemistry
SN - 0009-9120
ER -