International external quality assurance of JAK2 V617F quantification.
Asp JDepartment of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. julia.asp@gu.se.
Skov VDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Bellosillo BDepartment of Pathology, Hospital del Mar, Barcelona, Spain.
Kristensen TDepartment of Pathology, Odense University Hospital, Odense, Denmark.
Schwarz JInstitute of Hematology and Blood Transfusion, Prague, Czech Republic.
Wojtaszewska MDepartment of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poznan, Poland.
Palmqvist LDepartment of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Akiki SDepartment of Laboratory Medicine and Pathology, Qatar Rehabilitation Institute (QRI), Hamad Bin Khalifa Medical City (HBKM), Doha, Qatar.
Aggerholm AAarhus University Hospital, Aarhus, Denmark.
Kjær LDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Oppliger Leibundgut EUniversity Hospital Bern and University of Bern, Bern, Switzerland.
Pancrazzi ACentro di Ricerca e Innovazione per le Malattie Mieloproliferative (CRIMM), Florence, Italy.
Vorland MHaukeland University Hospital, Bergen, Norway.
Andrikovics HCentral Hospital of Southern Pest, Budapest, Hungary.
Kralovics RCeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria, and Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.
Cassinat BService de Biologie Cellulaire, AP-HP, Hopital Saint-Louis, Paris, France.
Coucelo MClinical Hematology Unit, Hospital Pediátrico, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Eftimov ACenter for Biomolecular Pharmaceutical Analyses, Faculty of Pharmacy, UKiM, Skopje, Republic of Macedonia.
Navaglia FDepartment of Laboratory Medicine, University - Hospital of Padova, Padova, Italy.
Novotny GWDepartment of Hematology and Department of Pathology, Molecular Unit, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.
English
External quality assurance (EQA) programs are vital to ensure high quality and standardized results in molecular diagnostics. It is important that EQA for quantitative analysis takes into account the variation in methodology. Results cannot be expected to be more accurate than limits of the technology used, and it is essential to recognize factors causing substantial outlier results. The present study aimed to identify parameters of specific importance for JAK2 V617F quantification by quantitative PCR, using different starting materials, assays, and technical platforms. Sixteen samples were issued to participating laboratories in two EQA rounds. In the first round, 19 laboratories from 11 European countries analyzing JAK2 V617F as part of their routine diagnostics returned results from in-house assays. In the second round, 25 laboratories from 17 countries participated. Despite variations in starting material, assay set-up and instrumentation the laboratories were generally well aligned in the EQA program. However, EQA based on a single technology appears to be a valuable tool to achieve standardization of the quantification of JAK2 V617F allelic burden.