B-021 Unclotting the Truth: A Comparison of Defibrinated Plasma-Based vs Lithium Heparin Plasma-Based High-Sensitivity Troponin I Quality Controls

Background The objective of this project was to compare lithium heparin plasma (LiH Plasma) and defibrinated plasma (DF Plasma) hs-cTnI controls focusing on clinical accuracy, precision, cost effectiveness, and workflow efficiency using the Siemens LOCI TNIH and the Beckman Coulter hsTnI assay platforms using a novel formulation of a tri level hs-cTnI control.High-sensitivity troponin I (hs-cTnI) is critical for early myocardial infarction diagnosis.Accurate QC materials ensure reliable cardiac risk stratification and clinical decision-making.Lithium heparin plasma and defibrinated plasma offer unique benefits that influence precision, consistency, and operational efficiency. Methods Instrumentation:Siemens Dimension EXLBeckman Coulter Access II Procedure:hs-cTnI concentrations were measured in quadruplet on both analyzers over the span of 5 daysEvaluated precision, recovery, matrix effects, and work flow impact. Statistical Analysis:Paired t-tests and Bland-Altman plots for accuracy and agreement.Coefficient of Variation (CV) for precision analysisRegression analysis for linearity assessmentCost analysis comparing reagent usage, processing time, and overall efficiency to end user Results Results showed LiH Plasma had inconsistent performance showing high accuracy and low precision. DF Plasma samples showed similar accuracy to the LiH Plasma samples but substantially higher precision. The DF Plasma showed a CV of 4.07, 1.82. and 2.45 for levels 1, 2, and 3 respectively. LiH Plasma produced a CV of 11.10, 12.55, and 8.63. Bland-Altman indicated good agreement between control types across both analyzers. Regression analysis confirmed linearity with coefficients (r^2) > 0.98 for all comparisons. Overall DF Plasma showed a faster processing time because of not needing a centrifuge period and reduced reagent usage as a result of biased results. DF Plasma QC also showed less of a need for recalibration mitigating spending on that aspect as well. Conclusion From the 2 lot study done on this project DF Plasma showed to have consistent QC performance, supporting reliable diagnostic decisions. While there are benefits to LiH Plasma when comparing to patient sample composition particularly in Siemens analyzers. However, DF Plasma provided more stable matrix conditions, improved workflow efficiency and reduced laboratory costs. This project was a result of the research and development of a novel QC material for More Diagnostic Inc. This information seemed relevant to the current market conditions and we felt it could benefit the future of the IVD market as a whole.