Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale

Soo Hyun Seo 1 , Seung Jun Leehttp://orcid.org/0000-0002-3377-4833 1 , Seungman Park 1 , Min Jin Kim 1 , Ji Yoon Song 1 , Eun Kyung Ra 1 , Sung Im Cho 1 , Hyun Kyung Kim 1 , Man Gil Yang 2 , Ji Yeon Kim 2 , Sung Sup Park, and Moon-Woo Seong 1
  • 1 Department of Laboratory Medicine, College of Medicine, Seoul National University Hospital, Seoul, Korea.
  • 2 Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea
  • 3 Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Korea
Soo Hyun Seo, Seung Jun LeeORCID iD: http://orcid.org/0000-0002-3377-4833, Seungman Park, Min Jin Kim, Ji Yoon Song, Eun Kyung Ra, Sung Im Cho, Hyun Kyung Kim, Man Gil Yang, Ji Yeon Kim, Sung Sup Park and Moon-Woo Seong

Abstract

Background: Quantifying the BCR-ABL1 rearrangement is important for monitoring chronic myelogenous leukemia (CML). To standardize BCR-ABL1 quantification, the World Health Organization (WHO) established the first international genetic reference panel. Here, we compared the BCR-ABL1 levels determined using international scale (IS)-based commercially available assays.

Methods: BCR-ABL1 transcripts were quantified using two IS-based assays. 10–1, 10–2, 10–3, 10–4, 10–5 and 10–6 dilutions of the b3a2 positive RNA were used for evaluating linearity, precision, and limit of detection. Correlation of the assay was evaluated by using DNA obtained from CML patients carrying the BCR-ABL1 b3a2 and b2a2 types.

Results: Both Ipsogen and Asuragen assays showed fine linearity with reasonable %CV. LOD of each assay was calculated as 0.003% for Ipsogen, and 0.005% for Asuragen. By comparing the results that were lower than 10% by either one of the assay, Ipsogen and Asuragen results showed an overall good linear correlation with a tendency for the Ipsogen assay to show slightly higher levels than the Asuragen assay for b3a2 transcript. For b2a2, the tendency was opposite, with Asuragen showing higher values than the Ipsogen.

Conclusions: Two commercially available IS-based BCR-ABL1 assays showed an overall good quantitative correlation. It should be taken into consideration that each assay tended to produce higher values than the other, depending on the BCR-ABL1 subtypes, suggesting that a separate conversion factor for each subtype can be more helpful when BCR-ABL1 transcript levels are converted into IS.

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