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Establishing hemolysis and lipemia acceptance thresholds for clinical chemistry tests.

Authors
  • Knezevic, Claire E1
  • Ness, Mary Ann1
  • Tsang, Polly Hoi Ting1
  • Tenney, Brandon J1
  • Marzinke, Mark A2
  • 1 Department of Pathology, Johns Hopkins Medical Institutes, Baltimore, MD, United States. , (United States)
  • 2 Department of Pathology, Johns Hopkins Medical Institutes, Baltimore, MD, United States. Electronic address: [email protected] , (United States)
Type
Published Article
Journal
Clinica chimica acta; international journal of clinical chemistry
Publication Date
Aug 07, 2020
Volume
510
Pages
459–465
Identifiers
DOI: 10.1016/j.cca.2020.08.004
PMID: 32771484
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

A key component of laboratory medicine is the evaluation of specimen suitability for downstream analytical testing. Accurate identification and characterization of the impact of interferents on clinical chemistry analytes is important for patient care. To empirically assess the influence of hemolysis and lipemia on clinical chemistry tests analyzed on a Roche cobas® c701 system, we evaluated serum pools spiked with increasing concentrations of hemolysate and Intralipid®. Using an interferent acceptance threshold of within ± 10% of the non-hemolyzed or non-lipemic results, 31 routine chemistry analytes were evaluated. The majority of analytes were determined to have the same or very similar acceptability thresholds as those listed in the vendor package insert. However, several analytes resulted in new thresholds that deviated from manufacturer recommendations (9 higher and 2 lower for lipemia, 7 higher and 6 lower for hemolysis). Samples with high enzyme activities (LDH, ALT, AST, ALP, and CK) were observed to tolerate higher levels of hemolysis, and tiered hemolysis thresholds were established for these enzymes. Independent evaluation of indices is recommended to enable thoughtful implementation of specimen quality criteria and to provide guidance to laboratorians and providers on the nature of these interferences. Copyright © 2020 Elsevier B.V. All rights reserved.

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