BCR ABL p210/p190 digital PCR one-tube quant test (CE-IVD)

BCR ABL p210/p190 digital PCR one-tube quant test is used to quantify the proportion of BCR-ABL p210 (e13a2 and/or e14a2) fusion gene and BCR-ABL p190 (e1a2) in human peripheral blood specimens from patients.

The test measures the e13a2 and/or e14a2 transcripts of BCR-ABL, normalized to the ABL1 endogenous control. Results are reported as a percent reduction from a baseline of 100% on the International Scale (%IS) and on a log molecular reduction (MR) scale. The test measures the e1a2 transcripts of BCR-ABL, normalized to the ABL1 endogenous control. The results are for quantitative reference only.

The test does not differentiate between e13a2 and/or e14a2 fusion transcripts.

* The product is CE-IVD certified