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Managing biological variation data: modern approaches for study design and clinical application.

For more than one half-century, variability observed in clinical test result measurements has been ascribed to three major independent factors: (i) pre-analytical variation, occurring at sample collection and processing steps; (ii) analytical variation of the test method for which measurements are t...

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Published in:Critical Reviews in Clinical Laboratory Sciences Vol. 58; no. 7; pp. 493 - 513
Main Authors: Johnson, Paul R., Shahangian, Shahram, Astles, J. Rex
Format: equations & formulas review tables/charts Journal Article
Published: Taylor & Francis Ltd November 2021
Online Access:View this record in EBSCOhost
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      dt: November 2021
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/10408363.2021.1932718
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        atl: Managing biological variation data: modern approaches for study design and clinical application.
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        au:
          Johnson, Paul R.
          Shahangian, Shahram
          Astles, J. Rex
        affil: Department of Clinical Laboratory Science, SUNY Upstate Medical University, Syracuse, NY, USA
      sug:
        subj:
          Study Design
          Reference Values
          Proficiency Testing, Laboratory
          Biological Markers
          Clinical Laboratories
          Prospective Studies
          Retrospective Design
      ab: For more than one half-century, variability observed in clinical test result measurements has been ascribed to three major independent factors: (i) pre-analytical variation, occurring at sample collection and processing steps; (ii) analytical variation of the test method for which measurements are taken, and; (iii) biological variation (BV). Appreciation of this last source of variability is the major goal of this review article. Several recent advances have been made to generate, collate, and utilize BV data of biomarker tests within the clinical laboratory setting. Consideration of both prospective and retrospective study designs will be addressed. The prospective/direct study design will be described in accordance with recent recommendations discussed in the framework of a newly-developed system of checklist items. Potential value of retrospective/indirect study design, modeled on data mining from cohort studies or pathology laboratory information systems (LIS), offers an alternative approach to obtain BV estimates for clinical biomarkers. Moreover, updates to BV databases have made these data more current and widely accessible. Principal aims of this review are to provide the clinical laboratory scientist with a historical framework of BV concepts, to highlight useful applications of BV data within the clinical laboratory environment, and to discuss key terms and concepts related to statistical treatment of BV data.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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