Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017.

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  • Additional Information
    • Affiliation:
      General Medicine Service, VA Puget Sound Health Care System, Seattle, Washington
      Health Services Research and Development, VA Puget Sound Health Care System, Seattle, Washington
      General Internal Medicine, University of Washington School of Medicine, Seattle
      Pathology Service, VA Iowa City, Iowa City
      Pathology Department, University of Iowa Carver College of Medicine, Iowa City
      Cooperative Studies Program Epidemiology Center, Durham VA Health Care System, Durham, North Carolina
      Gastroenterology Service, Duke University Medical Center, Durham, North Carolina
      Department of Health Services, University of Washington School of Public Health, Seattle
      Medical Service, VA Long Beach Healthcare System, Long Beach, California
      Gastroenterology Section, University of California, Irvine
      Medical Service, VA Portland Health Care System, Portland, Oregon
      Gastroenterology Service, Oregon Health and Sciences University School of Medicine, Portland
      Infectious Diseases Service, Oregon Health and Sciences University School of Medicine, Portland
      Department of Medicine (Gastroenterology and Hepatology), VA Palo Alto Health Care System, Palo Alto, California
      Medical Service (Gastroenterology and Hepatology), Stanford University, Palo Alto, California
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      * Context.--Disease guidelines specify universal alanine aminotransferase (ALT) thresholds for clinical decisionmaking, yet the effect of variability among ALT analyzers remains unclear. Objective.--To compare ALT results from different analyzers from 2012-2017. Design.--Veterans Health Administration (VHA) laboratories perform external ALT proficiency testing using standardized College of American Pathologists (CAP) samples in analyzers by 5 manufacturers. In this operational analysis, we evaluated 22 950 ALT values from 80 independent CAP samples tested at 223 laboratories. Using mixed effects modeling, we estimated the association between analyzer manufacturer and CAP outcome, adjusting for manufacturer, facility, and calendar year. We performed subgroup analyses on CAP samples with overall means near clinical guideline-specified thresholds, including less than 50 U/L (n = 10) and less than 35 U/L (n = 5). Results.--The VHA used Abbott Laboratories (n = 3175; 14%), Beckman Coulter Diagnostics (n = 8723; 38%), Roche Diagnostics (n = 2595; 11%), Siemens Healthineers USA (n=5713; 25%), and Vitros/Ortho Clinical Diagnostics (n = 2744; 12%) analyzers. The CAP samples (n = 80 samples, n=22 950 tests) covered a wide range of mean ALT values (21-268 U/L). The average difference in mean ALT value per sample between the highest-reading and lowestreading manufacturers was 15.4 U/L (SD = 1.8) for the 10 samples withmean ALT less than 50 U/L, and itwas 10.4 U/L (SD=3.6) overall (n=80). In linear mixed effects modeling, we found statistically significant differences in ALT values between the different manufacturers in each year. Conclusions.--We found statistically and clinically meaningful differences between analyzers across the ALT spectrum in each year, including at ALT levels lower than 50 U/L and lower than 35 U/L. Universal ALT thresholds should be avoided as a trigger for clinical action until differences between analyzers can be resolved.
    • Journal Subset:
      Allied Health; Biomedical; Peer Reviewed; USA
    • ISSN:
      0003-9985
    • MEDLINE Info:
      NLM UID: 7607091
    • Publication Date:
      20200530
    • Publication Date:
      20200601
    • DOI:
      10.5858/arpa.2018-0622-OA
    • Accession Number:
      143462122
  • Citations
    • ABNT:
      BESTE, L. A. et al. Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. Archives of Pathology & Laboratory Medicine, [s. l.], v. 144, n. 6, p. 748–754, 2020. DOI 10.5858/arpa.2018-0622-OA. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143462122. Acesso em: 25 set. 2020.
    • AMA:
      Beste LA, Icardi M, Hunt CM, et al. Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. Archives of Pathology & Laboratory Medicine. 2020;144(6):748-754. doi:10.5858/arpa.2018-0622-OA
    • APA:
      Beste, L. A., Icardi, M., Hunt, C. M., Gylys-Colwell, I., Lowy, E., Taylor, L., Morgan, T. R., Chang, M. F., Maier, M. M., & Cheung, R. (2020). Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. Archives of Pathology & Laboratory Medicine, 144(6), 748–754. https://doi.org/10.5858/arpa.2018-0622-OA
    • Chicago/Turabian: Author-Date:
      Beste, Lauren A., Michael Icardi, Christine M. Hunt, Ina Gylys-Colwell, Elliott Lowy, Leslie Taylor, Timothy R. Morgan, Michael F. Chang, Marissa M. Maier, and Ramsey Cheung. 2020. “Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017.” Archives of Pathology & Laboratory Medicine 144 (6): 748–54. doi:10.5858/arpa.2018-0622-OA.
    • Harvard:
      Beste, L. A. et al. (2020) ‘Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017’, Archives of Pathology & Laboratory Medicine, 144(6), pp. 748–754. doi: 10.5858/arpa.2018-0622-OA.
    • Harvard: Australian:
      Beste, LA, Icardi, M, Hunt, CM, Gylys-Colwell, I, Lowy, E, Taylor, L, Morgan, TR, Chang, MF, Maier, MM & Cheung, R 2020, ‘Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017’, Archives of Pathology & Laboratory Medicine, vol. 144, no. 6, pp. 748–754, viewed 25 September 2020, .
    • MLA:
      Beste, Lauren A., et al. “Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017.” Archives of Pathology & Laboratory Medicine, vol. 144, no. 6, June 2020, pp. 748–754. EBSCOhost, doi:10.5858/arpa.2018-0622-OA.
    • Chicago/Turabian: Humanities:
      Beste, Lauren A., Michael Icardi, Christine M. Hunt, Ina Gylys-Colwell, Elliott Lowy, Leslie Taylor, Timothy R. Morgan, Michael F. Chang, Marissa M. Maier, and Ramsey Cheung. “Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017.” Archives of Pathology & Laboratory Medicine 144, no. 6 (June 2020): 748–54. doi:10.5858/arpa.2018-0622-OA.
    • Vancouver/ICMJE:
      Beste LA, Icardi M, Hunt CM, Gylys-Colwell I, Lowy E, Taylor L, et al. Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. Archives of Pathology & Laboratory Medicine [Internet]. 2020 Jun [cited 2020 Sep 25];144(6):748–54. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143462122