Abstract
We report the analytical performances of two particle-enhanced (PETIA) methods for measuring procalcitonin (PCT), the Diazyme PCT and the new DiaSys PCT assay, and their concordance of values with BRAHMS PCT Kryptor©. The total imprecisions onto two control levels and one serum pool were for DiaSys 5.42%, 3.3% and 7.53% and for Diazyme 10.7%, 2.9% and 13.23%, respectively. The limit of blank, limit of detection and limit of quantification were under the 0.25 cut-off for the two methods. The linearity in the lower range was acceptable for both methods. No significant effect on PCT determination was observed for DiaSys’ assay upon addition of interfering substances. With the Diazyme assay, significant effects were seen with rheumatoid factor (RF), lipid and hemoglobin. Correlation studies on 136 sera showed a good correlation between PCT measurements using DiaSys assay against the Kryptor system, while only a poor correlation was observed between the Diazyme assay, especially for low values. The novel PETIA PCT assay from DiaSys shows analytical performances acceptable for clinical use and the concordance with Kryptor method was fine at all clinical cut-offs. In contrast, despite comparable analytical performances, the Diazyme PETIA method exhibited a poor concordance with the Kryptor method.
Highlights
In the last decade, procalcitonin (PCT) has emerged as a useful biomarker in diagnosis and management of sepsis, and has become an essential parameter to differentiate bacterial from viral infections in different cohorts of patients [1,2]
While the coefficient of variation (CV) at level 2 was comparable for the two PETIA methods, the CV at level 1 from PCT Diazyme assay (10.07%) was twice higher than that of PCT
This study demonstrated that the analytical performances of the PETIA method from DiaSys reagents applied on c502 Cobas 8000© from Roche are acceptable for clinical use and that the DiaSys
Summary
Procalcitonin (PCT) has emerged as a useful biomarker in diagnosis and management of sepsis, and has become an essential parameter to differentiate bacterial from viral infections in different cohorts of patients [1,2]. Meta-analyses have proven dramatically increased mortality in emergency patient populations when PCT values were higher than 0.25 μg/L and 0.5 μg/L [5]. Different cut-offs have been suggested for determining the bacterial origin of the Diagnostics 2020, 10, 461; doi:10.3390/diagnostics10070461 www.mdpi.com/journal/diagnostics. PCT could be a helpful biomarker to reduce patient exposure to antibiotics without any significant effect on mortality [1,8]. A recent meta-analysis suggests that procalcitonin-guided therapy could reduce mortality in critically ills [9]. All the clinical cut-off values have been defined according to the first available method for measuring PCT, the BRAHMS PCT assay
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