In July 2020, five months after the product launch, Dupuy (et al.) published the first peer-reviewed publication on Procalcitonin FS in the MDPI (Multidisciplinary Digital Publishing Institute) journal Diagnostics (Vol. 10, Issue 7). The study compared the performance of DiaSys' new procalcitonin assay with BRAHMS PCT Kryptor© and another turbidimetric assay. DiaSys Procalcitonin FS demonstrated its strengths in the study and can truly be accepted as a reliable alternative for clinical use.
The determinations with DiaSys Procalcitonin FS were performed on cobas c 502 module obtaining LOQ below 0.2 ng/mL in this study. In a method comparison of 138 samples against BRAHMS PCT Kryptor© the DiaSys assay revealed high correlation.
Covering the clinical decision points of 0.5 and 2 ng/mL, Passing-Bablok regression and Bland-Altman analysis confirmed the good correlation for samples in the range of 0-2 ng/mL (PCT DiaSys = 0.994 x PCT Kryptor + 0.11).
The agreement at different clinical cut-offs was also monitored. Compared to BRAHMS, only nine samples were overestimated by DiaSys at 0.5 ng/mL. Despite the different analytic results, some values still agreed to the final diagnosis, revealing false negative and false positive results for BRAHMS and the other PETIA as well. Finally, global kappa coefficients indicated a good strength of agreement for DiaSys Procalcitonin.
DiaSys particle-enhanced immunoturbidimetric assay Procalcitonin FS offers cost-efficient testing, is applicable on a wide range of photometric systems, free from common interferences, and enables fast and accurate results.
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A. M. Dupuy et al., ‘Bioanalytical Performance of a New Particle-Enhanced Method for Measuring Procalcitonin’, Diagnostics, vol. 10, no. 7, p. 461, Jul. 2020, doi: 10.3390/diagnostics10070461.