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KMID : 1100720200400010072
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Annals of Laboratory Medicine
2020 Volume.40 No. 1 p.72 ~ p.75
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Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay
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Chung Hee-Jung
Hur Mi-Na
Yoon Su-Mi
Hwang Keum-Rock
Lim Hwan-Sub
Kim Han-Ah
Moon Hee-Won
Yun Yeo-Min
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Abstract
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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.
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KEYWORD
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BCR-ABL, Droplet digital PCR, Performance, Evaluation, Chronic myeloid leukemia
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