Analytical Performance Evaluation of BioRad’s Unassayed Multiqual, Immunoassay Plus and Assayed Multiqual InteliQ Tube-Based Quality Control Materials

Abstract

Abstract Introduction Quality control (QC) practices commonly require aliquoting of liquid material into sample cups prior to analysis. Recently, newer tube-based QC has become available that can be scanned directly onto the analyzer without additional aliquoting. In this study, we evaluate the performance of the BioRad’s Unassayed Multiqual (Mutiqual), Immunoassay (IA) Plus and Assayed InteliQ Muliqual (InteliQ) tube-based QC material. Materials and Methods The analytical performance of Multiqual, IA Plus and InteliQ materials were compared over 14 days at three concentrations on an Abbott Alinity ci analyzer system. The analysis included 20 unique clinical chemistry and 4 immunoassay analytes. For an applied comparison, all QC materials were analyzed using the same lot on multiple days, times, and by various laboratory team members (n=10). The means, standard deviations (SD) and coefficient of variation (CV) were calculated for each analyte. Minimum acceptable allowable imprecision (I) specifications were set using the biological variation (BV) database from European Federation for Laboratory Medicine (EFLM), which was calculated for each analyte using the equation I = 0.75*CV within-subject. Sample cups used for Multiqual and IA plus were also calculated to determine consumable waste for these materials over the study period and extrapolated for a year. Results Multiqual, IA Plus and InteliQ CVs for each analyte were compared to the EFLM BV database and showed comparable results for most analytes studied. Most analytes demonstrated < 5% CV over the 14-day period for InteliQ except alkaline phosphatase, bicarbonate, total bilirubin, and triiodothyronine for either 1, 2 or 3 levels. Total bilirubin and free thyroxine were outside this CV for Multiqual and IA Plus. In addition, minimum acceptable allowable imprecision goals from EFLM were not met for several analytes that were included in InteliQ such as albumin, alkaline phosphatase, aspartate aminotransferase, calcium, bicarbonate, chloride, and sodium. Multiqual and IA plus analytes that did not meet imprecision goals were bicarbonate, chloride, sodium, and free thyroxine, respectively. A total of 84 sample cups were needed to perform Multiqual and IA plus QC analysis over the study period or approximately 2184 over a year. Conclusion Multiqual, IA Plus and InteliQ QC materials provide similar analytical performance although each material had some analytes that did not meet acceptable imprecision limits defined by EFLM. Implementation of new tube-based QC materials can reduce sample cup consumables and may reduce technologist time required to aliquot Multiqual and IA Plus.