Kosin Med J.  2024 Dec;39(4):272-280. 10.7180/kmj.24.155.

Comparative analysis of Access PCT and Elecsys BRAHMS PCT assays for procalcitonin measurements

• Choi H
• Lee SS
• Hwang H

• KMID: 2562811
• DOI: http://doi.org/10.7180/kmj.24.155

Abstract

Background
Procalcitonin (PCT) is a crucial biomarker for diagnosing sepsis and managing antibiotic therapy. This study evaluated the analytical performance and comparability of the Access PCT and Elecsys BRAHMS PCT assays.
Methods
The precision, detection capability, linearity, and reference range of both assays were assessed. A comparative analysis included 182 patient samples categorized into four risk groups to compare the results between Access PCT and Elecsys BRAHMS PCT assays.
Results
The Access PCT assay demonstrated precision within the manufacturer’s threshold, and its detection capabilities were verified. This assay exhibited excellent linearity and appropriate reference intervals. Comparative analysis indicated that the Access PCT assay reported higher overall PCT levels than the Elecsys BRAHMS assay, with high agreement between the assays (κ=0.941). However, the biases varied across different PCT concentration intervals.
Conclusions
Both the Access PCT and Elecsys BRAHMS PCT assays performed robustly with notable concordance but varying biases at different concentration intervals. The observed biases require careful consideration in clinical decision-making, especially when adopting novel assay systems. Standardizing the calibration across different platforms is recommended to improve assay comparability.

Keyword

Agreement; Detection capability; Linearity; Precision; Procalcitonin

Figure

• 

  Fig. 1. Linearity analysis of PCT. (A) Linearity data versus linearity fit. (B) Comparison of ADL to the deviation from linearity. PCT, procalcitonin; ADL, allowable deviation from linearity; CI, confidence interval.

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  Fig. 2. Comparative analysis of the Access PCT and Elecsys PCT assays. (A) Bland-Altman plot assessing agreement. (B) Passing-Bablok regression for correlation. PCT, procalcitonin; LoA, limits of agreement.

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  Fig. 3. Comparison of Bland-Altman plots (blue line) and Passing-Bablok (red line) regression of the Elecsys PCT and Access PCT assays. (A, B) Group 1, <0.5 μg/L; (C, D) group 2, ≥0.5 to <2.0 μg/L; (E, F) group 3, 2.0 ≥ to <10 μg/L; and (G, H) group 4, ≥10 μg/L. PCT, procalcitonin; LoA, limits of agreement.

Reference

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