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Research Project

European external quality control program for laboratory diagnosis of alpha1-antitrypsin deficiency

Principal Investigator:
Joanna Chorostowska-Wynimko / Ilaria Ferrarotti
National Institute of Tuberculosis and Lung Diseases / IRCCS San Matteo Hospital Foundation
Warsaw (Poland) / Pavia (Italy)
Start date:
December 1st 2018
Contact E-mail:
j.chorostowska@gmail.com / ilaria.ferrarotti@unipv.it
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The Organization for Economic Co-operation and Development (OECD) strongly recommends to strengthen international co-operation and facilitate, where appropriate, the cross-border flow of samples for clinical purposes in accordance with recognized principles for their handling, storage, safety, privacy and confidentiality. Most of the molecular test guidelines encourage active dissemination of quality standards through training and facilitation. Moreover, regular monitoring and specific actions are recommended to ensure that standards are being met and performance improvements are maintained. Yet, there are no specific reference materials available for genetic and biochemical tests for AATD in use today. This lack prevents any quality control of lab testing.
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The main aims of the project are:
• To introduce the pilot quality control program for six leading European laboratories involved in diagnosis AATD in order to verify the accuracy of their diagnostic procedures.
• To design the on-going external quality scheme for AATD laboratory diagnostic procedures in Europe (2018- first round, 2019-2021)

Inclusion criteria

Central laboratories for diagnosis of AATD in Europe

Brief summary

The current project has been divided into two parts:
1) Laboratory Survey
2) External Quality Control Program

Laboratory Survey
A specific questionnaire was designed in March 2018 . It consisted of five parts related to:
A) general activities of the Lab (10 questions)
B) quantitative tests (8 questions)
C) qualitative test (17 questions)
D) general organization of the Lab (24 questions)

The survey was completed by six labs of the project by September 2018.

External Quality Control Program
The scheme of external quality control program has been designed, by taking into consideration the survey feed-back.
The validation steps (Round 1 and Round 2) involved Warsaw and Pavia labs. Analysis comprised of AAT and CRP quantification, phenotyping by IEF, genotyping for S and Z alleles; each analysis were performed both in serum and DBS.
Round 1 (January 2019) samples shipped from Pavia to Warsaw.
Round 2 (May 2019) samples shipped from Warsaw to Pavia.
Round 3 (August 2019) involved 6 labs (Warsaw, Pavia, Barcelona, Lille, Marburg, and Dublin) with Pavia as the reference lab. Samples were expected to be analyzed in respective participating labs in accordance with their routine diagnostic processes (SOPs).
Round 4 (December 2019) involved 6 labs (Warsaw, Pavia, Barcelona, Lille, Marburg, and Dublin) with Warsaw as the reference lab.