Procalcitonin Chemiluminescent Immunoassay - Bias Estimation on Multiplatform.

Abstract

Background: Procalcitonin (PCT) is a useful biomarker for infection and especially useful for sepsis management. Multiple platforms, including the chemiluminescence immunoassay (CLIA), have been used for serum PCT analysis. However, the results from different analytical platforms should be evaluated to determine if they can be mutually substituted in the same laboratory.

Methods: The serum PCT were analyzed on the Mindray CL-6000i chemiluminescent immunoassay (candidate method), the Roche Elecsys, and the VIDAS PCT chemiluminescence immunoassay platforms (comparative measurements), and the results were evaluated and compared, following the CLSI EP09-A3 guidelines, by using patient samples with different PCT concentrations.

Results: The median of difference was 0.04 (95% CI: 0.038 - 0.045) between the candidate method and the comparative measurements for the concentration interval of < 0.5 ng/mL. The median of percentage difference was 6.6% (95% CI: 5.5% - 8.7%) for the concentration interval of 0.5 - 2.0 ng/mL, the median of difference was 0.11 (95% CI: 0.06 - 0.17) for the concentration interval of 2.0 - 10.0 ng/mL, and the median of percentage difference was -4.7% (95% CI: -6.1% - 2.4%) for the concentration interval of 10.0 - 100.0 ng/mL. The acceptable bias was ± 0.055 (± 10.4%) at 0.53 ng/mL (low value), and the acceptable bias was ± 0.83 (± 9.0%) at 9.34 ng/mL (high value). The bias between the candidate method and comparative measurements was acceptable for the full concentration ranges.

Conclusions: The bias between the PCT results from Mindray, Roche, and VIDAS was acceptable. Therefore, the results of the three analytical platforms were comparable, and they may be mixed-used in the same institution.