title: Preliminary experience in external quality control of RT-PCR PML-RAR alpha detection in promyelocytic leukemia.
abstract: To standardize the results obtained in PML/RAR alpha RT-PCR detection by laboratories of hospitals involved in the Spanish Program for Treatment of Hematological Malignancies (PETHEMA) LPA-96, designed for the treatment of acute promyelocytic leukemia (APL), cDNA samples obtained by reverse transcription of RNA from bone marrow samples of patients with APL were sent to participating laboratories. During the first year of this external quality assessment trial nine samples were tested by a maximum of 12 laboratories. The control gene was satisfactorily amplified in 90% of the samples (62 of 69 samples), supporting the adequacy of the cDNA to be used as control sample. There was an 83% concordance between laboratories for PML/RAR alpha detection with similar results for the type of PML/RR alpha rearrangements. However, 17% disagreement still remained, attributable to low sensitivity or inadequacy of methods followed. The results stressed the need for implementation of an external quality assessment scheme to ensure the standardization of the results.
authors.affiliation: Laboratorio de Biología Molecular, Biopatología Clínica, Hospital Universitario La Fe, Valencia, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Bolufer
authors.forename: E
authors.initials: E
authors.lastname: Barragán
authors.forename: M A
authors.initials: MA
authors.lastname: Sánz
authors.forename: G
authors.initials: G
authors.lastname: Martín
authors.forename: R
authors.initials: R
authors.lastname: Bornstein
authors.forename: D
authors.initials: D
authors.lastname: Colomer
authors.forename: M D
authors.initials: MD
authors.lastname: Delgado
authors.forename: M
authors.initials: M
authors.lastname: González
authors.forename: I
authors.initials: I
authors.lastname: Marugan
authors.forename: J
authors.initials: J
authors.lastname: Román
authors.forename: M T
authors.initials: MT
authors.lastname: Gómez
authors.forename: E
authors.initials: E
authors.lastname: Anguita
authors.forename: D
authors.initials: D
authors.lastname: Diverio
authors.forename: C
authors.initials: C
authors.lastname: Chomienne
authors.forename: M
authors.initials: M
authors.lastname: Briz
mesh_terms: D005784:Gene Amplification; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000235:genetics*; D009363:Neoplasm Proteins / Q000032:analysis*; D015514:Oncogene Proteins, Fusion / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000592:standards*; D013030:Spain
chemical_list: D009363:Neoplasm Proteins; D015514:Oncogene Proteins, Fusion; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein