A-125 Evaluation of Commercial Serum Indices Quality Control Materials for a Coagulation HIL Module

Abstract Background The STA R MAX³ and STA Compact Max³, coagulation analyzers developed by Diagnostica Stago (Parsippany, NJ), are able to perform clotting, chromogenic and immunoturbidimetric tests simultaneously, using a Viscosity Based Detection System. They are also equipped with a preanalytical module that can evaluate for the presence of hemolysis, icterus, and lipemia (HIL) in samples prior to analysis. Evaluation of specimen suitability for downstream analytical testing and the identification of potential interferents in coagulation specimens is essential for ensuring the accuracy and reliability of clinical results. In the clinical laboratory, hemolysis, icterus, and lipemia are evaluated for coagulation testing using spectrophotometric methods. While coagulation laboratories rely on analyte-specific quality control (QC) materials to monitor test and instrument performance, quality assurance materials evaluating specimen integrity checks are infrequently utilized. The purpose of this evaluation was to assess a commercial serum indices product designed to monitor an instrument*s performance in detecting hemolyzed, icteric, or lipemic samples. Methods Commercially available specimen integrity materials were evaluated on two coagulation analyzers: the STA R MAX³ and STA Compact Max³ by a certified and trained medical laboratory professional. Target arbitrary values for the hemolysis, icterus, and lipemia QC materials were 200, 23, and 184, respectively. Each serum indices level was tested in duplicate, twice a day, across both analyzers for with the same aliquots for each analyzer and for each interferent. Semi-quantitative data comparisons were performed using a proposed lookup table for the preanalytical module that compared Stago HIL indices to Bio-Rad Liquichek (Bio-Rad Laboratories, Irvine, CA) reference tables. Results Between the STA R MAX³ and STA Compact Max³, hemolysis and icterus were determined to have the same semi-quantitative acceptability thresholds as those listed in the manufacturer package insert using the proposed lookup table. Lipemia testing, based on human sourced material, resulted in a new acceptability threshold that deviated slightly from manufacturer recommendations (1 semi-quantitative level higher for the lipemia material). Manufacturer provided quantitative values obtained for the Bio-Rad Liquichek Serum Indices product were approximate targets from a clinical chemistry analyzer. Conclusion The Bio-Rad Liquichek Serum Indices product can serve as an effective means of monitoring specimen integrity checks on the STA R MAX3 and STA Compact Max3 EPC module and brings benefit to the total quality assurance process. Independent evaluation of commercial HIL indices material as an unassayed product is recommended to enable informative implementation of specimen quality criteria and to provide guidance to laboratorians and providers on the nature of these interferences.