2007
DOI: 10.2353/jmoldx.2007.060112
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Evaluation of the Cepheid GeneXpert BCR-ABL Assay

Abstract: Patients with chronic myeloid leukemia harbor the chromosomal translocation t(9;22), which corresponds to fusion of the BCR and ABL genes at the DNA level. The translated fusion product is an oncogenic protein with increased ABL tyrosine kinase activity causing cell transformation. To date, reverse transcriptase-polymerase chain reaction is considered the most sensitive method available for detecting low copy numbers of the BCR-ABL gene fusion. Recently, Cepheid introduced its GeneXpert-based assay for the ide… Show more

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Cited by 47 publications
(28 citation statements)
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“…This result fits the conventional definition of the lower LOD, in which the sample is measured as positive 95% of the time. Similar results were reported in a separate evaluation by Johns Hopkins University scientists (27 ).…”
Section: Assay Linear Range and Lodsupporting
confidence: 89%
“…This result fits the conventional definition of the lower LOD, in which the sample is measured as positive 95% of the time. Similar results were reported in a separate evaluation by Johns Hopkins University scientists (27 ).…”
Section: Assay Linear Range and Lodsupporting
confidence: 89%
“…8 Concordances for CMR were comparable between the two laboratories and positive/negative discordant results were only observed among samples with positivity below 0.1%, in line with previously published data. 9,10 These data suggest that there is no significant bias in achieving CMR and its impact on therapeutic decisions, such as stopping TKI.…”
Section: Discussionmentioning
confidence: 87%
“…The 5 log range of linearity for automated quantification ( Figure 2) is in line with that previously described. 9,10 Reproducible results at these low levels of minimal residual disease were significantly more frequently obtained when pre-analytical steps were reduced to six hours or less, compared to 24 hours. We emphasize that this situation may only apply to patients undergoing treatment with TKI, in which case the samples remain in contact with the TKI during the pre-analytical phase.…”
Section: Discussionmentioning
confidence: 99%
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