Quality control of flow cytometry data analysis for evaluation of minimal residual disease in bone marrow from acute leukemia patients during treatment.
Low levels of leukemia cells in the bone marrow, minimal residual disease (MRD), are considered to be a powerful indicator of treatment response in acute lymphatic leukemia (ALL). A Nordic quality assurance program, aimed on standardization of the flow cytometry MRD analysis, has been established before implementation of MRD at cutoff level 10 as one of stratifying parameters in next Nordic Society of Pediatric Hematology and Oncology (NOPHO) treatment program for ALL. In 4 quality control (QC) rounds 15 laboratories determined the MRD levels in 48 follow-up samples from 12 ALL patients treated according to NOPHO 2000. Analysis procedures were standardized. For each QC round a compact disc containing data in list-mode files was sent out and results were submitted to a central laboratory. At cutoff level 10, which will be applied for clinical decisions, laboratories obtained a high concordance (91.6%). If cutoff level 10 was applied, the concordance would be lower (85.3%). The continuing standardization resulted in better concordance in QC3 and QC4 compared with QC1 and QC2. The concordance was higher in precursor B as compared with T-cell ALL. We conclude that after standardization, flow cytometry MRD detection can be reliably applied in international, multicenter treatment protocols.
Björklund
Elisabet
E
Department of Pathology and Cytology, Karolinska University Hospital, Solna, Karolinska Institute, Stockholm SE 171 76, Sweden. elisabet.bjorklund@karolinska.se
Matinlauri
Irma
I
Tierens
Anne
A
Axelsson
Susanne
S
Forestier
Erik
E
Jacobsson
Stefan
S
Ahlberg
Asa Jeppsson
AJ
Kauric
Goran
G
Mäntymaa
Pentti
P
Osnes
Liv
L
Penttilä
Tarja-Leena
TL
Marquart
Hanne
H
Savolainen
Eeva-Riitta
ER
Siitonen
Sanna
S
Torikka
Kerstin
K
Mazur
Joanna
J
Porwit
Anna
A
D000293:Adolescent; D001853:Bone Marrow / Q000473:pathology; D001856:Bone Marrow Examination / Q000592:standards; D002648:Child; D002675:Child, Preschool; D005260:Female; D005434:Flow Cytometry / Q000592:standards*; D006801:Humans; D008297:Male; D008495:Medical Oncology / Q000592:standards; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000175:diagnosis*; D010338:Pathology, Clinical / Q000592:standards*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000175:diagnosis*; D011786:Quality Control