A-072 An All-Purpose Particle Enhanced Immunoturbidimetric Assay for the Comparable, Instrument-Independent Monitoring of Procalcitonin in the Management of Sepsis

Abstract

Abstract Introduction Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection. It is a global health concern and a leading cause of death worldwide, affecting an estimate of 48.9 million people every year. Procalcitonin (PCT) revealed to be an indispensable parameter for the management of sepsis. However, recent analysis of EQA survey results suggested crucial deviations of PCT measurements in Germany and studies by the IFCC Working Group on standardization of PCT stated the need for a higher-order reference measurement procedure.Here we present the evaluation of the all-purpose particle enhanced immunoturbidimetric assay (PETIA) of DiaSys, which can be easily applied to every high-throughput clinical chemistry analyzer. The high diversity of applications and datasets match current diagnostic and regulative needs (IVDR). Procalcitonin FS enables the equivalent and instrument-independent monitoring of PCT in the management of sepsis. Methodology Evaluation of Procalcitonin FS was performed on seven clinical chemistry analyzer platforms (Jeol BioMajesty® JCA-BM6010/C, DiaSys respons®920 and respons®940, Roche cobas c501, Abbott Architect c8000 and Alinity c, Beckman Olympus AU680). Measurements were performed according to Clinical and Laboratory Standards Institute (CLSI) protocols. Results The onboard stability reaches 8 weeks (with chimney) on BioMajesty® JCA-BM6010/C, 20 days on respons®920 and respons®940, 21 weeks on cobas c501, 9 weeks on Architect, 12 weeks on Olympus AU680 and 13 weeks on Alinity c. The calibration stability is 4 weeks (with chimney) on BioMajesty® JCA-BM6010/C, 2 weeks (with chimney) on respons®920 and respons®940, 21 weeks on cobas c501, 3 weeks on Architect, 5 weeks on Olympus AU680 and 10 weeks on Alinity c. The intra-assay precision (CV%) ranges from ≤4.57% on respons®920 up to ≤7.19% on respons®940. The Total Precision (CV%) ranges from ≤3.99% on cobas c501 up to ≤9.62% on Olympus AU680. LOB ranges from 0.07 ng/mL on BioMajesty® JCA-BM6010/C up to 0.130 ng/mL on Olympus AU680. LOQ ranges from 0.20 ng/mL on Architect up to 0.277 ng/mL on Olympus AU680. The reagent displayed a linear recovery up to 50 ng/mL and no prozone effect was detected up to 1000 ng/mL on all seven analyzers. The Passing & Bablok regression vs the reference test showed an excellent comparability/alignment between the methods (slope ≤1.11, intercept ≤0.156 ng/mL, R ≥ 0.986). Conclusion Evaluation work proves that DiaSys PETIA reagent Procalcitonin FS shows excellent performance on all seven clinical chemistry analyzers. In addition, the high comparability between the seven analyzers enables the reliable and instrument-independent monitoring of PCT in the management of sepsis, and thus offering a solution to the current landscape of deviating PCT measurement results.