Lab Med Online.  2023 Jul;13(3):182-188. 10.47429/lmo.2023.13.3.182.

Comparison Between ADVIA Centaur XP and cobas e801 for Prostate-Specific Antigen Assays using Large-Scale Clinical Samples

• Yu S
• Kim SM
• Park HD

• KMID: 2552742
• DOI: http://doi.org/10.47429/lmo.2023.13.3.182

Abstract

Background
Prostate-specific antigen (PSA) is the first-line test for screening prostate malignancy. However, PSA levels vary between measurement procedures (MPs). In this study, we evaluated the precision and linearity of cobas e801 (Roche Diagnostics, Germany) and evaluated the clinical impact based on the bias with ADVIA Centaur XP (Siemens Healthineers, USA) in subjects under medical checkup.
Methods
This study followed the Clinical and Laboratory Standards Institute EP05-A3, EP06-A, and EP09c guidelines each for precision, linearity, and comparison. We evaluated simultaneously measured 5,373 patient samples and the health check examinee samples by Centaur XP (n= 97,271) and cobas e801 (n = 51,640).
Results
The repeatability was 2.04%–2.68% and the within-laboratory precision was 1.34–1.57%. The best polynomial regression was the first order in the range of 0.06–99.70 ng/mL. The biases of lower and higher concentrations were -0.013 ng/mL (95% Confidence Interval (CI): -0.014 to -0.013) and 14.0% (95% CI: 13.9–14.1), respectively. Two MPs were correlated (y= -0.024+1.151x, R= 0.952). However, the bias between the MPs (14.3%) was acceptable only with the minimum analytical performance specifications for bias (16.0%). The Cohen’s kappa was 0.933. The overall positive rate of PSA level (> 3.0 ng/mL) was 3.93% (Centaur XP) and 5.41% (cobas e801). The positivity rate of the examinee in their sixties showed significant difference (Centaur XP 4.46% vs. cobas e801 7.27%, P < 0.001), which was statistically comparable due to the similar age distribution.
Conclusions
cobas e801 exhibited appropriate precision and linearity. Although the bias between two MPs was acceptable, there was diagnostic difference. Caution with clinical application of PSA levels would be required.

Keyword

ADVIA Centaur XP; Bias estimation; cobas e801; Method comparison; Prostate-specific antigen

Figure

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  Fig. 1 Linearity of cobas e801 for PSA (μg/L).

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  Fig. 2 (A) Passing–Bablok regression (B) Ranked order unit difference plot (C) Ranked order percent difference plot.

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  Fig. 3 (A) Unit difference plot of lower concentration (0.01–0.32 μg/L) (B) Ranked order percent difference plot of higher concentration (0.32–10,000 μg/L) (C) Box and Whisker plot after removal of outliers at lower and higher concentration.

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