Bioanalytical Performance of a New Particle-Enhanced Method for Measuring Procalcitonin
Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Université Montpellier 1, F-34295 CEDEX 5 Montpellier, France
Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, 34295 Montpellier, France
Département de Réanimation, CHU Montpellier, Université Montpellier 1, F-34295 CEDEX 5 Montpellier, France
Institute of Molecular Medicine I, Medical Faculty, Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany
Author to whom correspondence should be addressed.
Diagnostics 2020, 10(7), 461; https://doi.org/10.3390/diagnostics10070461
Received: 6 May 2020 / Revised: 1 July 2020 / Accepted: 2 July 2020 / Published: 7 July 2020
(This article belongs to the Section Point-of-Care Diagnostics and Devices)
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.