Evaluation and operationalization of commercial serum indices quality control material in the clinical laboratory

•Specimen integrity is critical for the generation of reliable and actionable clinical results.•Hemolysis, icterus, and lipemia, are common interferents in clinical chemistry assays.•Bio-Rad serum indices QC materials serve as an effective way of monitoring specimen integrity. Evaluation of specimen...

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Bibliographic Details
Published in:Clinica chimica acta 2022-02, Vol.526, p.1-5
Main Authors: Marzinke, Mark A., Mitchell, Sondra, Ness, Mary Ann, Tenney, Brandon J., Neil, Rebecca, Vandepoele, Nico
Format: Article
Language:English
Subjects:
Hemolysis
Humans
Hyperlipidemias - diagnosis
Jaundice
Laboratories, Clinical
Quality Control
Serum indices
Specimen integrity
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Summary:•Specimen integrity is critical for the generation of reliable and actionable clinical results.•Hemolysis, icterus, and lipemia, are common interferents in clinical chemistry assays.•Bio-Rad serum indices QC materials serve as an effective way of monitoring specimen integrity. Evaluation of specimen suitability for downstream analytical testing and identification of potential interferents in the clinical laboratory is critical for the generation of actionable clinical results. Within the clinical laboratory, hemolysis, icterus, and lipemia are commonly assessed spectrophotometrically. While clinical laboratories rely on analyte-specific quality control (QC) materials to monitor test or instrument performance, QC materials evaluating specimen integrity checks are infrequently implemented. Using commercially available specimen integrity materials, we evaluated the Bio-Rad Liquichek™ Serum Indices product on Roche cobas® c701 analyzers at a large academic medical center. Target arbitrary values for the hemolysis, icterus, and lipemia QC materials were 200, 20, and 500, respectively. Means, standard deviations (SD), and coefficients of variation (%CV) were established for hemolysis, icterus, lipemia, and non-interfered QCs, and performance was monitored over a 60-day period. Across four c701 instruments, all QC materials performed well, with %CVs ≤ 1.76%, 4.51%, and 3.46% for hemolysis, icterus, and lipemia QC, respectively. The Bio-Rad Liquichek Serum Indices product can serve as an effective means of monitoring specimen integrity checks in a manner congruous with existing QC programs.
ISSN:0009-8981
1873-3492
DOI:10.1016/j.cca.2021.12.013