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. 2022 Apr 12:30:e00274.
doi: 10.1016/j.plabm.2022.e00274. eCollection 2022 May.

Comparison of a novel automated DiaSys procalcitonin immunoassay with four different BRAHMS-partnered immunoassays

Abass Eidizadeh  1 , Mechthild Wiederhold  1 , Moritz Schnelle  1 , Lutz Binder  1
Affiliations

Comparison of a novel automated DiaSys procalcitonin immunoassay with four different BRAHMS-partnered immunoassays

Abass Eidizadeh et al. Pract Lab Med. .

Abstract

Objectives: Procalcitonin (PCT) is an important biomarker of sepsis and respiratory infections. Various automated immunoassays for measuring PCT in patient plasma are available in medical laboratories. However, due to a lack of international reference material for PCT, the assays are not always comparable.

Design and methods: In this study, we compared a new turbidimetric immunoassay from DiaSys, measured on the Abbott Architect c16000 and Alinity c, with four BRAHMS-associated chemiluminescence immunoassays (Abbott Architect i2000SR, Alinity i, Roche Cobas e411 and DiaSorin Liaison XL) using 120 random patient plasma samples from the clinical laboratory routine at the University Medical Center Goettingen.

Results: The DiaSys assay showed clear differences as compared to the BRAHMS-associated assays when measured on Architect c: i.e. 58% positive mean bias vs. Architect i, 67% vs. Cobas and 23% vs. Liaison. As a result, additional 19% our patients would have a suspected bacterial infection, when using PCT values from the DiaSys assay and commonly accepted decision limits. A crosscheck of the DiaSys calibrator on the BRAHMS-associated systems showed a low recovery of the calibrator material (approx. 50%).

Conclusions: Overall, this study shows significant differences between the DiaSys and BRAHMS-associated assays. This could be attributed to a potential DiaSys calibrator problem. This highlights the need for an international reference material for harmonization of the PCT assays.

Keywords: Abbott; Alinity; Architect; Bacterial infection; Calibration; Cobas; Comparison; DiaSys; Diasorin; Immunoassay; Liaison; PCT; PETIA; Procalcitonin; Reference material; Roche; Sepsis; Standardization.

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Conflict of interest statement

The authors have declared that no conflict of interest exists.

Figures

Fig. 1
Fig. 1
Passing-Bablok regression analysis (A–C) and Bland-Altman difference plots (D–F) on Architect, Cobas and Liaison. Passing-Bablok regression and Bland-Altman difference plots were performed from PCT measurements in 120 plasma samples between DiaSys PCT assay on Architect c and three BRAHMS-associated assays on Architect i, Liaison and Cobas. 95% confidence intervals (CI) are presented as dotted lines. Linear equations with Pearson's correlation coefficients (r) are presented in the respective figures. In difference plots, each normalized difference is plotted against the respective sample rank determined by the average of both respective measurements.
Fig. 2
Fig. 2
Passing-Bablok regression analysis and Bland-Altman difference plots on Alinity i, Alinity c and Architect. Passing-Bablok regression and Bland-Altman difference plots were performed from PCT measurements in 120 plasma samples between DiaSys PCT assay on Architect c and Alinity c and two Abbott BRAHMS-associated assays on Architect i and Alinity i. 95% confidence intervals (CI) are presented as dotted lines. Linear equations with Pearson's correlation coefficients (r) are presented in the respective figures. In difference plots, each normalized difference is plotted against the respective sample rank determined by the average of both respective measurements.
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