Analytical evaluation of the novel VITROS BRAHMS procalcitonin immunoassay

Abstract

To determine the analytical performance of Novel VITROS BRAHMS Procalcitonin Immunoassay on VITROS 3600 and correlation with BRAHMS PCT sensitive KRYPTOR reference method. Analytical performances including imprecision studies, linearity, limit of detection (LoD) and determination of hemolysis index were performed for VITROS BRAHMS PCT assay. Imprecision was assessed on plasma pool and internal control with 2 levels. The method comparison was performed using 162 plasma obtained from clinical departments. The total imprecision was acceptable and all CV were <5%. The LoD was in accordance with manufacturer’s claims. The equation of linearity in the lower range was found to be y = 1.0014x – 0.0091, with r² = 1. No interference to hemoglobin up to 11 g/L was observed. Correlation studies showed a good correlation between PCT measurements using VITROS BRAHMS PCT assay against KRYPTOR system including for values lower than 2 µg/L. The novel VITROS BRAHMS PCT assay from OrthoClinical Diagnostics shows analytical performances acceptable for clinical use. In addition, the concordance with KRYPTOR method was fine at all clinical cut-offs.

Keywords:

• Procalcitonin
• data accuracy
• correlation of data
• cut-off
• standardization

Acknowledgements

Reagents, calibrators, quality controls for the VITROS B·R·A·H·M·S PCT assay that were used in this study were kindly provided by Ortho Clinical Diagnostic France. The authors thank ProBioQual for kindly providing their data.

Disclosure statement

No potential conflict of interest was reported by the author(s).