Format

Send to

Choose Destination
Clin Biochem. 2016 May;49(7-8):601-5. doi: 10.1016/j.clinbiochem.2015.12.014. Epub 2016 Feb 3.

The Italian pilot external quality assessment program for cystic fibrosis sweat test.

Author information

1
National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy. Electronic address: marco.salvatore@iss.it.
2
National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
3
Laboratory of Clinical Molecular and Personalized Diagnostics, Policlinico Universitario A. Gemelli, Roma, Italy.
4
LABSIEM - Laboratory for the Study of Inborn Errors of Metabolism, Genoa University, DINOGMI, Genoa, Italy.
5
CEINGE - Advanced Biotechnology Scarl, Naples, Italy; Department of Molecular Medicine and Medical Biotechnology, University of Naples Federico II, Naples, Italy.
6
Cystic Fibrosis Referral Care Center, Mother-Child Department, United Hospitals, Salesi Children's Hospital, Ancona, Italy.
7
Regional Screening Centre, Istituti Clinici di Perfezionamento, Milan, Lombardia Region, Italy.
8
Cystic Fibrosis Support Center, Paediatric Department, Children's Hospital, AO Spedali Civili, Brescia, Italy.
9
Regional Cystic Fibrosis Center, Pediatric Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.

Abstract

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.

KEYWORDS:

CFTR gene; Chloride; Cystic fibrosis; EQA; Sweat test

[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center