CHANGES TO THE REPORTING OF BCR-ABL1 MONITORING RESULTS
In April 2020, Cepheid released a new version of the Xpert BCR-ABL1 Ultra assay. While the assay chemistry remains unchanged, this upgrade results in a change to the way BCR-ABL1 results are reported. This assay version has a linear range of 0.0030% IS to 55% IS. Reporting of results will include the addition of the Molecular Response (MR).
In-house verification of the assay shows no difference in the transcript levels between the two assay versions, with an R2
value of 0.992, an average bias of 0.02 log % IS and a standard deviation of 0.108.
The table below gives an example of how different patient results are reported.
These changes have come into effect in September 2020.
Chor Ee Tan