Two-center comparison of 10 fully-automated commercial procalcitonin (PCT) immunoassays

Giuseppe Lippi; Gian Luca Salvagno; Matteo Gelati; Mairi Pucci; Claudia Lo Cascio; Davide Demonte; Diego Faggian; Mario Plebani

doi:10.1515/cclm-2019-0888

Article

Two-center comparison of 10 fully-automated commercial procalcitonin (PCT) immunoassays

Giuseppe Lippi , Gian Luca Salvagno , Matteo Gelati , Mairi Pucci , Claudia Lo Cascio , Davide Demonte , Diego Faggian and Mario Plebani

Published/Copyright: September 20, 2019

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 58 Issue 1

Abstract

Background

This two-center study was designed to verify comparability of procalcitonin (PCT) values among 10 different commercial immunoassays.

Methods

A total number of 176 routine lithium-heparin plasma samples were divided in identical aliquots and simultaneously analyzed with 10 different PCT immunoassays, including Kryptor BRAHMS PCT sensitive, Abbott Architect BRAHMS PCT, Beckman Coulter Access PCT (on Access and DXI), BioMérieux Vidas BRAHMS PCT, Diasorin Liaison BRAHMS PCT, Fujirebio Lumipulse G BRAHMS PCT, Roche BRAHMS PCT (on Cobas E801), Diazyme PCT (on Roche Cobas C702) and SNIBE Maglumi PCT.

Results

Highly significant correlation was always found across multiple comparisons, with correlation coefficients comprised between 0.918 and 0.997 (all p < 0.001). Bland and Altman plots analysis revealed highly variable bias among immunoassays, ranging between ±0.2% and ±38.6%. Diazyme PCT on Roche Cobas C702 and SNIBE Maglumi PCT displayed the larger overestimation, whilst PCT values were underestimated by Cobas BRAHAMS PCT. The agreement was always >80% (all p < 0.001), but varied largely across multiple comparisons, ranging between 90%–99% at 0.1 μg/L, 81%–99% at 0.25 μg/L, 83%–100% at 0.5 μg/L, 94%–100% at 2.0 μg/L and 90%–99% at 10 μg/L, respectively. The larger disagreement was observed comparing Diazyme PCT and Maglumi PCT with the other methods.

Conclusions

Although we found acceptable correlation among 10 commercial PCT immunoassays, the limited agreement at clinical decision thresholds remains a major issue, especially at lower end of PCT concentration, thus potentially contributing to jeopardize the clinical value of this biomarker.

Keywords: immunoassay; procalcitonin; sepsis; two-center

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2019-08-21

Accepted: 2019-08-30

Published Online: 2019-09-20

Published in Print: 2019-12-18

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Articles in the same Issue

https://doi.org/10.1515/cclm-2019-0888

Keywords for this article

immunoassay; procalcitonin; sepsis; two-center