Hemolysis indexes for biochemical tests and immunoassays on Roche analyzers: Determination of allowable interference limits according to different calculation methods. (April 2015)

• Record Type: Journal Article
• Authors: Monneret, Denis; Mestari, Fouzi; Atlan, Gregory; Corlouer, Camille; Ramani, Zo; Jaffre, Jeremy; Dever, Sylvie; Fressart, Veronique; Alkouri, Rana; Lamari, Foudil; Devilliers, Catherine; Imbert-Bismut, Françoise; Bonnefont-Rousselot, Dominique
• Is Part Of: Scandinavian journal of clinical & laboratory investigation. Volume 75:Number 2(2015)
• Page Start: 162
• Page End: 169
• Publication Date: 2015-04
• Subjects: Clinical biochemistry -- Periodicals; Physiology, Pathological -- Periodicals; Physiology, Experimental -- Periodicals; Medicine -- Research -- Periodicals; Clinical medicine -- Periodicals; 616.0072
• DOI: 10.3109/00365513.2014.993691
• Languages: English
• ISSNs: 0036-5513

Abstract

<abstract> <title>Abstract</title> <p> <bold> <italic>Objectives.</italic> </bold> To determine the hemolysis interference on biochemical tests and immunoassays performed on Roche Diagnostics analyzers, according to different maximum allowable limits. <bold><italic>Design and methods.</italic></bold> Heparinized plasma and serum pools, free of interferences, were overloaded by increasing amounts of a hemoglobin-titrated hemolysate. This interference was evaluated for 45 analytes using Modular<sup>®</sup> and Cobas<sup>®</sup> analyzers. For each parameter, the hemolysis index (HI) corresponding to the traditional ± 10% change of concentrations from baseline (± 10%Δ) was determined, as well as those corresponding to the analytical change limit (ACL), and to the reference change value (RCV). Then, the relative frequencies distribution (% RFD) of hemolyzed tests performed in a hospital laboratory over a 25-day period were established for each HI as allowable limit. <bold><italic>Results.</italic></bold> Considering the ± 10%Δ, the analyte concentrations enhanced by hemolysis were: Lactate dehydrogenase (LDH), aspartate aminotransferase (AST), folate, potassium, creatine kinase, phosphorus, iron, alanine aminotransferase, lipase, magnesium and triglycerides, decreasingly. The analyte concentrations decreased by hemolysis were: Haptoglobin, high-sensitive troponin T and alkaline phosphatase. Over the 25-day period, the % RFD of tests impacted more than 10%Δ by hemolysis were < 7% for LDH; < 5% for AST, folates and iron; and < 1% for the other analytes. Considering the ACL, HI were lower, giving % RFD substantially increased for many analytes, whereas only four analytes remain sensitive to hemolysis when considering RCV. <bold><italic>Conclusion.</italic></bold> This study proposes new HI based on different allowable limits, and can therefore serve as a starting point for future harmonization of hemolysis interference evaluation needed in routine laboratory practice.</p> </abstract>