Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale
-
Soo Hyun Seo
,
Seungman Park
Abstract
Background: Quantifying the BCR-ABL1 rearrangement is important for monitoring chronic myelogenous leukemia (CML). To standardize BCR-ABL1 quantification, the World Health Organization (WHO) established the first international genetic reference panel. Here, we compared the BCR-ABL1 levels determined using international scale (IS)-based commercially available assays.
Methods: BCR-ABL1 transcripts were quantified using two IS-based assays. 10–1, 10–2, 10–3, 10–4, 10–5 and 10–6 dilutions of the b3a2 positive RNA were used for evaluating linearity, precision, and limit of detection. Correlation of the assay was evaluated by using DNA obtained from CML patients carrying the BCR-ABL1 b3a2 and b2a2 types.
Results: Both Ipsogen and Asuragen assays showed fine linearity with reasonable %CV. LOD of each assay was calculated as 0.003% for Ipsogen, and 0.005% for Asuragen. By comparing the results that were lower than 10% by either one of the assay, Ipsogen and Asuragen results showed an overall good linear correlation with a tendency for the Ipsogen assay to show slightly higher levels than the Asuragen assay for b3a2 transcript. For b2a2, the tendency was opposite, with Asuragen showing higher values than the Ipsogen.
Conclusions: Two commercially available IS-based BCR-ABL1 assays showed an overall good quantitative correlation. It should be taken into consideration that each assay tended to produce higher values than the other, depending on the BCR-ABL1 subtypes, suggesting that a separate conversion factor for each subtype can be more helpful when BCR-ABL1 transcript levels are converted into IS.
References
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©2016 by De Gruyter
Articles in the same Issue
- Frontmatter
- In Memoriam: Gérard Siest (1936–2016)
- Editorials
- Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine
- The quality indicator paradox
- Review
- Clinical utility of the (-2)proPSA and evaluation of the evidence: a systematic review
- Mini Review
- Why are clinical practice guidelines not followed?
- EFLM Position Paper
- Patient identification and tube labelling – a call for harmonisation
- Genetics and Molecular Diagnostics
- A fast and simple method for detecting and quantifying donor-derived cell-free DNA in sera of solid organ transplant recipients as a biomarker for graft function
- Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale
- HAND1 loss-of-function mutation associated with familial dilated cardiomyopathy
- General Clinical Chemistry and Laboratory Medicine
- Performance criteria and quality indicators for the post-analytical phase
- Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements
- Quantitative determination of four immunosuppressants by high resolution mass spectrometry (HRMS)
- Measurement of plasma vitamin K1 (phylloquinone) and K2 (menaquinones-4 and -7) using HPLC-tandem mass spectrometry
- Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits
- High level of oxysterols in neonatal cholestasis: a pitfall in analysis of biochemical markers for Niemann-Pick type C disease
- Reference Values and Biological Variations
- Reference intervals of plasma homoarginine from the German Gutenberg Health Study
- TSH and fT4 during pregnancy: an observational study and a review of the literature
- Cancer Diagnostics
- Mean corpuscular volume levels and all-cause and liver cancer mortality
- Cardiovascular Diseases
- Circulating endothelial-derived apoptotic microparticles and insulin resistance in non-diabetic patients with chronic heart failure
- Hematology and Coagulation
- Platelet aggregation in response to ADP is highly variable in normal donors and patients on anti-platelet medication
- Letters to the Editor
- EQA-derived metrics to assess overall instrument performance
- Misidentification in laboratory medicine and diagnostic process: a neglected problem calling for action
- Impact of the routine implementation of automated indirect immunofluorescence antinuclear antibody analysis: 1 year of experience
- The importance of angiogenic markers in the differential diagnosis of HELLP syndrome vs. non-HELLP thrombocytopenia
- Bisalbuminemia accompanying bisalbuminuria detected in capillary electrophoresis, not in gel electrophoresis
- Prognostic value of red blood cell distribution width in acute pancreatitis patients admitted to intensive care units: an analysis of a publicly accessible clinical database MIMIC II
- Differences in analytical and biological results between older and newer lots of a widely used irisin immunoassay question the validity of previous studies
- A diagnostic algorithm for the detection of inhibitors against coagulation Factor V
- Interference of anticoagulants on coagulation testing
- Congress Abstracts
- Swiss MedLab 2016 and 74th Annual Meeting of the Swiss Society of Microbiology SSM, Bern, 13–16 June 2016
Articles in the same Issue
- Frontmatter
- In Memoriam: Gérard Siest (1936–2016)
- Editorials
- Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine
- The quality indicator paradox
- Review
- Clinical utility of the (-2)proPSA and evaluation of the evidence: a systematic review
- Mini Review
- Why are clinical practice guidelines not followed?
- EFLM Position Paper
- Patient identification and tube labelling – a call for harmonisation
- Genetics and Molecular Diagnostics
- A fast and simple method for detecting and quantifying donor-derived cell-free DNA in sera of solid organ transplant recipients as a biomarker for graft function
- Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale
- HAND1 loss-of-function mutation associated with familial dilated cardiomyopathy
- General Clinical Chemistry and Laboratory Medicine
- Performance criteria and quality indicators for the post-analytical phase
- Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements
- Quantitative determination of four immunosuppressants by high resolution mass spectrometry (HRMS)
- Measurement of plasma vitamin K1 (phylloquinone) and K2 (menaquinones-4 and -7) using HPLC-tandem mass spectrometry
- Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits
- High level of oxysterols in neonatal cholestasis: a pitfall in analysis of biochemical markers for Niemann-Pick type C disease
- Reference Values and Biological Variations
- Reference intervals of plasma homoarginine from the German Gutenberg Health Study
- TSH and fT4 during pregnancy: an observational study and a review of the literature
- Cancer Diagnostics
- Mean corpuscular volume levels and all-cause and liver cancer mortality
- Cardiovascular Diseases
- Circulating endothelial-derived apoptotic microparticles and insulin resistance in non-diabetic patients with chronic heart failure
- Hematology and Coagulation
- Platelet aggregation in response to ADP is highly variable in normal donors and patients on anti-platelet medication
- Letters to the Editor
- EQA-derived metrics to assess overall instrument performance
- Misidentification in laboratory medicine and diagnostic process: a neglected problem calling for action
- Impact of the routine implementation of automated indirect immunofluorescence antinuclear antibody analysis: 1 year of experience
- The importance of angiogenic markers in the differential diagnosis of HELLP syndrome vs. non-HELLP thrombocytopenia
- Bisalbuminemia accompanying bisalbuminuria detected in capillary electrophoresis, not in gel electrophoresis
- Prognostic value of red blood cell distribution width in acute pancreatitis patients admitted to intensive care units: an analysis of a publicly accessible clinical database MIMIC II
- Differences in analytical and biological results between older and newer lots of a widely used irisin immunoassay question the validity of previous studies
- A diagnostic algorithm for the detection of inhibitors against coagulation Factor V
- Interference of anticoagulants on coagulation testing
- Congress Abstracts
- Swiss MedLab 2016 and 74th Annual Meeting of the Swiss Society of Microbiology SSM, Bern, 13–16 June 2016
