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

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 regulatory needs (IVDR). In addition, the high comparability between the seven analyzers enables the reliable and instrument-independent monitoring of PCT in the management of sepsis, thus offering a solution to the current landscape of deviating PCT measurement results.

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Evaluation of a new accurate and reliable particle enhanced immunoturbidimetric assay for the detection of Procalcitonin in the management of sepsis

The Third International Consensus Definitions for Sepsis and Septic Shock redefined sepsis as the life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is considered as a major public healthcare issue affecting more than 30 million people worldwide, associated with a mortality of potentially 6 million people and accounts for almost $24 billion in health care expenditures only in the US, annually. As the quick and accurate sepsis management reduces a possible negative clinical course and the economic burden, a multiplicity of plasma biomarker have been developed  to overcome the long turn-around time of the blood culture. [...]