A novel approach for <i><scp>BCR</scp>‐<scp>ABL</scp>1</i> standardization to improve International Scale estimation

Maes, Brigitte; Bâkkus, Marleen; Boeckx, Nancy; Boone, Elke; Cauwelier, Bárbara; Denys, Barbara; Schouwer, Pieter De; Devos, Timothy; Housni, Hakim El; Hillen, Femke; Jacobs, K; Lambert, Frédéric; Louagie, Henk; Maes, Marie-Berthe; Meeus, Peter; Moreau, E; Nollet, Friedel; Peeters, Kristel; Saussoy, Pascale; Lint, Philippe Van; Vaerman, Jean-Pierre; Vaeyens, Freya; Vandepoele, Karl; Vannuffel, Pascal; Elst, K. Ver; Vermeulen, Katrien; Bruyndonckx, Robin

doi:10.1111/ijlh.12556

Cited by 2 publications

(1 citation statement)

References 11 publications

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“…In addition, it is the first panel applicable to BCR and GUSB in addition to ABL1 . Innovative approaches to IS conversion (Maes et al , ), using mathematical comparison with EQA data, may also improve access to the IS.…”

Section: Discussionmentioning

confidence: 99%

Measurement ofBCR-ABL1by RT-qPCR in chronic myeloid leukaemia: findings from an International EQA Programme

et al. 2017

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Sequential measurement of BCR-ABL1 mRNA levels by reverse transcription quantitative polymerase chain reaction (RT-qPCR) is embedded in the management of patients with chronic myeloid leukaemia (CML), and has played an important role in the remarkable improvement in patient outcomes seen in this disease. As a provider of external quality assessment (EQA) in this area, UK NEQAS for Leucocyte Immunophenotyping (UKNEQAS LI) has a unique perspective on the changing face of BCR-ABL1 testing in CML. To assess the impact of technical standardisation and the development of the International Scale (IS) upon the accuracy of BCR-ABL1 testing, we reviewed EQA trial data from 2007 to 2015. Comparison of participant results identified considerable variability at both high and low levels of disease, including therapeutically important decision points; however, results converted to the IS showed less variability compared to unconverted data sets. We also found that different methods of converting to the IS produce consistently different median results within UKNEQAS LI IS data sets. This data suggests that whilst the development of the IS has improved the comparability of results between centres, there is still the need for further improvement in the processes of converting raw results to the IS in order to fully realise the benefits of molecular monitoring of CML.

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Section: Discussionmentioning

confidence: 99%

Measurement ofBCR-ABL1by RT-qPCR in chronic myeloid leukaemia: findings from an International EQA Programme

et al. 2017

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Variant‐specific BCR::ABL1 quantification discrepancy in chronic myeloid leukemia

Jacobs,

Moerman,

Vandepoele

et al. 2024

Int J Lab Hematology

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IntroductionAccurate quantification of the BCR::ABL1 fusion gene in whole blood is pivotal for the clinical management of chronic myeloid leukemia (CML) patients. The fusion protein encoded by BCR::ABL1 can vary in size, depending on the BCR and/or ABL1 gene breakpoint. The vast majority of CML patients have a p210 BCR::ABL1 fusion gene (M‐BCR), which can be attributed to the presence of either e14a2 (b3a2) or e13a2 (b2a2) mRNA transcript junctions.MethodsTwenty‐five CML samples were analyzed in two different ISO15189‐accredited centers that both use an Europe Against Cancer‐based quantitative polymerase chain reaction (qPCR) protocol. Reanalysis of the sample set with transcript‐specific standard curves and digital droplet PCR (ddPCR) were performed.ResultsqPCR quantification revealed a significant (up to 1 log) difference specifically for the e13a2 transcript variant in contrast to e14a2 transcripts (Hodges–Lehman 4.29; p < 0.001). Reanalysis of the sample set with transcript‐specific standard curves abolishes the initial transcript‐specific difference (Hodges–Lehman 0.003; p = 0.8192). Comparison of transcript‐specific qPCR results of both centers with ddPCR, an absolute quantification method, showed a statically significant association, especially in the lower range, indicating the clinical utility of transcript‐specific or absolute quantification methods.ConclusionOur data show that differences between transcript‐specific quantification might exist between centers, leading to potential clinical impact on the follow‐up of CML patients. The use of transcript‐specific standard curves for qPCR quantification, or absolute quantification, can significantly reduce these differences. Specific attention should be applied to the interpretation of quantification differences of CML patients that switch between diagnostic centers.

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A novel approach for BCR‐ABL1 standardization to improve International Scale estimation

Abstract: We have demonstrated by thorough statistical validation that this approach performs well in converting BCR-ABL1 measurements to improve IS estimation. In expectation of a true golden standard method for BCR-ABL1 IS quantification, the proposed method is a valuable alternative.

Cited by 2 publications

References 11 publications

Measurement ofBCR-ABL1by RT-qPCR in chronic myeloid leukaemia: findings from an International EQA Programme

Measurement ofBCR-ABL1by RT-qPCR in chronic myeloid leukaemia: findings from an International EQA Programme

Variant‐specific BCR::ABL1 quantification discrepancy in chronic myeloid leukemia

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