Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay
- Author:
Hee Jung CHUNG
1
;
Mina HUR
;
Sumi YOON
;
Keumrock HWANG
;
Hwan Sub LIM
;
Hanah KIM
;
Hee Won MOON
;
Yeo Min YUN
Author Information
- Publication Type:Brief Communication
- From:Annals of Laboratory Medicine 2020;40(1):72-75
- CountryRepublic of Korea
- Language:English
- Abstract: Accurate detection of BCR-ABL fusion transcripts at and below molecular response (MR) 4 (0.01% International Scale [IS]) is required for disease monitoring in patients with chronic myeloid leukemia (CML). We evaluated the analytical performance of the QXDx BCR-ABL %IS (Bio-Rad, Hercules, CA, USA) droplet digital PCR (ddPCR) assay, which is the first commercially available ddPCR-based in vitro diagnostics product. In precision analysis, the %CV was 9.3% and 3.0%, with mean values of 0.031% IS and 9.4% IS, respectively. The assay was linear in the first order, ranging from 0.032% IS to 20% IS. The manufacturer-claimed limit of blank, limit of detection, and limit of quantification were verified successfully. There was a very strong correlation between the results of the QXDx BCR-ABL %IS ddPCR assay and the ipsogen BCR-ABL1 Mbcr IS-MMR (Qiagen, Hilden, Germany) real-time quantitative PCR assay (r=0.996). In conclusion, the QXDx BCR-ABL %IS ddPCR assay can provide reliable results for CML patients.
