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BCR-ABL1 (p210) Transcript Kinetics: A Rational Basis for Delta Checks in Quantitative Polymerase Chain Reaction Testing.

Context.--Delta checks are a powerful technique for monitoring clinical assays in many disciplines but have not been routinely used in molecular testing. Objective.--To determine if the biologically determined kinetics of BCR-ABL1's rise and fall could allow the development of a delta check in BCR-A...

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Published in:Archives of Pathology & Laboratory Medicine Vol. 146; no. 9; pp. 1140 - 1144
Main Authors: Ng, David P., Karner, Kristin Hunt
Format: pictorial research tables/charts Journal Article
Published: College of American Pathologists Sep2022
Online Access:View this record in EBSCOhost
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      dt: Sep2022
      vid: 146
      iid: 9
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      pub: College of American Pathologists
      place: Northfield, Illinois
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        158841092
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        10.5858/arpa.2021-0121-OA
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        atl: BCR-ABL1 (p210) Transcript Kinetics: A Rational Basis for Delta Checks in Quantitative Polymerase Chain Reaction Testing.
      aug:
        au:
          Ng, David P.
          Karner, Kristin Hunt
        affil: City, Utah, and Section of Hematopathology, ARUP Laboratories, Salt Lake City, Utah
      sug:
        subj:
          Proteins
          Polymerase Chain Reaction
          Leukemia, Myeloid, Chronic
          Kinetics
          Human
          Retrospective Design
          Descriptive Statistics
          Data Analysis Software
          Biological Assay
      ab: Context.--Delta checks are a powerful technique for monitoring clinical assays in many disciplines but have not been routinely used in molecular testing. Objective.--To determine if the biologically determined kinetics of BCR-ABL1's rise and fall could allow the development of a delta check in BCR-ABL1 testing. Design.--Nine years of BCR-ABL1 p210 results were evaluated, and patients with 3 or more results were selected for inclusion. The kinetics of these percentages of international standard values were plotted against time along with the median and the 90th and 95th percentile lines. A Monte Carlo simulation of a batch mix-up was performed for 6 months of data to determine the efficacy of the proposed cutoff. Results.--The median kinetics showed a 1-log drop of the percentage of international standard in 90 days, with less than 5% of cases showing faster than a 2-log drop in 90 days, and less than 2.5% showing a faster than 3-log drop in 90 days (extrapolated to 1 log in 30 days). The Monte Carlo simulation of a batch mix-up showed that an average batch mix-up of 23 samples could routinely be flagged by this cutoff, albeit with wide variance. Conclusions.--These results suggest that using a drop in the percentage of international standard of greater than 1 log in 30 days can be a useful trigger in implementing a delta-check system for this molecular test.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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