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

Giuseppe Lippi 1 , Gian Luca Salvagno 1 , Matteo Gelati 1 , Mairi Pucci 1 , Claudia Lo Cascio 1 , Davide Demontehttp://orcid.org/https://orcid.org/0000-0002-9710-3764 1 , Diego Faggian 2  and Mario Plebanihttp://orcid.org/https://orcid.org/0000-0002-0270-1711 2
  • 1 Section of Clinical Biochemistry, University Hospital of Verona, Verona, Italy
  • 2 Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy
Giuseppe Lippi, Gian Luca Salvagno, Matteo Gelati, Mairi Pucci, Claudia Lo Cascio, Davide DemonteORCID iD: https://orcid.org/0000-0002-9710-3764, Diego Faggian and Mario PlebaniORCID iD: https://orcid.org/0000-0002-0270-1711

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.

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Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.

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