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

Publication ,  Conference
Beste, LA; Icardi, M; Hunt, CM; Gylys-Colwell, I; Lowy, E; Taylor, L; Morgan, TR; Chang, MF; Maier, MM; Cheung, R
Published in: Arch Pathol Lab Med
June 2020

CONTEXT.—: Disease guidelines specify universal alanine aminotransferase (ALT) thresholds for clinical decision-making, 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 lowest-reading manufacturers was 15.4 U/L (SD = 1.8) for the 10 samples with mean ALT less than 50 U/L, and it was 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.

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Published In

Arch Pathol Lab Med

DOI

EISSN

1543-2165

Publication Date

June 2020

Volume

144

Issue

6

Start / End Page

748 / 754

Location

United States

Related Subject Headings

  • Pathology
  • Laboratory Proficiency Testing
  • Laboratories
  • Humans
  • Blood Chemical Analysis
  • Alanine Transaminase
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
 

Citation

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Chicago
ICMJE
MLA
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Beste, L. A., Icardi, M., Hunt, C. M., Gylys-Colwell, I., Lowy, E., Taylor, L., … Cheung, R. (2020). Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. In Arch Pathol Lab Med (Vol. 144, pp. 748–754). United States. https://doi.org/10.5858/arpa.2018-0622-OA
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.” In Arch Pathol Lab Med, 144:748–54, 2020. https://doi.org/10.5858/arpa.2018-0622-OA.
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. In: Arch Pathol Lab Med. 2020. p. 748–54.
Beste, Lauren A., et al. “Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017.Arch Pathol Lab Med, vol. 144, no. 6, 2020, pp. 748–54. Pubmed, doi:10.5858/arpa.2018-0622-OA.
Beste LA, Icardi M, Hunt CM, Gylys-Colwell I, Lowy E, Taylor L, Morgan TR, Chang MF, Maier MM, Cheung R. Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017. Arch Pathol Lab Med. 2020. p. 748–754.

Published In

Arch Pathol Lab Med

DOI

EISSN

1543-2165

Publication Date

June 2020

Volume

144

Issue

6

Start / End Page

748 / 754

Location

United States

Related Subject Headings

  • Pathology
  • Laboratory Proficiency Testing
  • Laboratories
  • Humans
  • Blood Chemical Analysis
  • Alanine Transaminase
  • 3202 Clinical sciences
  • 1103 Clinical Sciences