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Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia
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Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia
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Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia
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Journal Article
Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia
2022
Overview
Chronic myelogenous leukemia (CML) is a hematopoietic stem cell malignancy that accounts for 15–20% of all cases of leukemia. CML is caused by a translocation between chromosomes 9 and 22 which creates an abnormal fusion gene, BCR :: ABL1 . The amount of BCR :: ABL1 transcript RNA is a marker of disease progression and the effectiveness of tyrosine kinase inhibitor (TKI) treatment. This study determined the analytical and clinical performance of a droplet digital PCR based assay (QXDx BCR-ABL %IS Kit; Bio-Rad) for BCR :: ABL1 quantification. The test has a limit of detection of MR4.7 (0.002%) and a linear range of MR0.3–4.7 (50–0.002%IS). Reproducibility of results across multiple sites, days, instruments, and users was evaluated using panels made from BCR :: ABL1 positive patient samples. Clinical performance of the assay was evaluated on patient samples and compared to an existing FDA-cleared test. The reproducibility study noted negligible contributions to variance from site, instrument, day, and user for samples spanning from MR 0.7–4.2. The assay demonstrated excellent clinical correlation with the comparator test using a Deming regression with a Pearson R of 0.99, slope of 1.037 and intercept of 0.1084. This data establishes that the QXDx ™ BCR-ABL %IS Kit is an accurate, precise, and sensitive system for the diagnosis and monitoring of CML.
Publisher
Public Library of Science,Public Library of Science (PLoS)
Subject
/ Assaying
/ Biology
/ Blood
/ Cancer
/ Computer and Information Sciences
/ Droplets
/ Fusion Proteins, bcr-abl - genetics
/ Humans
/ Kinases
/ Leukemia
/ Leukemia, Myelogenous, Chronic, BCR-ABL Positive - diagnosis
/ Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy
/ Leukemia, Myelogenous, Chronic, BCR-ABL Positive - genetics
/ Medicine and Health Sciences
/ Noise
/ Patients
/ Polymerase Chain Reaction - methods
/ Protein Kinase Inhibitors - therapeutic use
/ Research and analysis methods
/ Tyrosine
