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