AI Article Synopsis
- The study focused on comparing the effectiveness and reproducibility of an automated assay (Xpert BCR-ABL Monitor™) versus non-automated methods for monitoring chronic myeloid leukemia patients treated with tyrosine kinase inhibitors.
- Results showed that the automated assays had similar reproducibility to standardized non-automated assays, and converting automated results to the international scale was feasible, though cost-effectiveness favored automation for lower sample volumes.
- The findings suggest that the Xpert BCR-ABL Monitor™ could be used effectively in routine clinical settings, but further research is needed to determine its prognostic value compared to non-automated methods.
Article Abstract
Background: Molecular monitoring of chronic myeloid leukemia patients treated with tyrosine kinase inhibitors is essential for therapeutic stratification. Inter-laboratory reproducibility is, therefore, a crucial issue which requires standardization and strict alignment of BCR-ABL1 values to the international scale. An automated cartridge-based assay (Xpert BCR-ABL Monitor(™), Cepheid) had been proposed as a robust alternative to non-automated assays. This study aimed to compare inter-laboratory reproducibility of automated and non-automated quantification, the possibility of converting automated results to the international scale, and the potential economic impact of automation.
Design And Methods: One hundred and eighteen blood samples from chronic myeloid leukemia patients treated with tyrosine kinase inhibitors were prospectively analyzed in two laboratories using both automated and non-automated assays. The economic evaluation involved a micro-costing study and average costs were assessed as a function of sample throughput.
Results: Automated assays achieved similar inter-laboratory reproducibility to highly standardized non-automated assays and a short delay (≤6 h) between sampling and blood lysis had a positive impact on inter-laboratory reproducibility. Reporting automated BCR-ABL1 ratios on the international scale was possible using a specific conversion factor which may vary with batches. Cost assessment showed that automated assays could be relevant for annual activity levels below 300 since average costs were lower than those of the non-automated assays.
Conclusions: The Xpert BCR-ABL Monitor(™) assay could be appropriately used in a near-patient setting for routine quantification of e13/e14-a2 transcripts, preferably in partnership with a regional reference laboratory. However, its prognostic impact relative to non-automated quantification remains to be tested prospectively within appropriate clinical trials.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3084912 | PMC |
| http://dx.doi.org/10.3324/haematol.2010.034389 | DOI Listing |
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