Key result
The Beckman Coulter Access procalcitonin assay demonstrated excellent correlation (r = 0.999; p < 0.001) and negligible bias (3.2%) when compared to the BRAHMS PCT-sensitive Kryptor assay.
Why the study?
The analytical performance of the recently commercialized Beckman Coulter Access procalcitonin chemiluminescent test on the Access immunoassay system required evaluation.
Effect estimate: r = 0.999
p-value: p=< 0.001
The Beckman Coulter Access PCT assay demonstrates excellent analytical performance and high comparability with the established BRAHMS PCT-sensitive Kryptor assay.
Supports Access PCT assay evaluation in labs; leaves open clinical outcome impact.
This study was designed to evaluate the analytical performance of the recently commercialized Beckman Coulter Access procalcitonin (PCT) chemiluminescent test on the Access immunoassay system. The analytical assessment encompassed the estimation of limit of blank (LoB), limit of detection (LoD), functional sensitivity (i.e., PCT value with ≤10% imprecision), linearity, imprecision and comparability of values with BRAHMS PCT-sensitive Kryptor. LoB, LoD and functional sensitivity were 0.002 μg/L, 0.003 μg/L and 0.003 μg/L, respectively. Intra-assay, inter-assay and total imprecision for plasma pools with low, medium and high PCT values were 1.8–2.1%, 2.4–3.7% and 3.1–4.3%, respectively. The assay exhibited excellent linearity between 0.02 and 84.0 μg/L. Excellent correlation (r = 0.999; p < 0.001) and negligible bias (3.2%) were found by comparing values obtained in paired plasma samples with BRAHMS PCT-sensitive Kryptor. Diagnostic agreement at 0.5, 2.0 and 10 μg/L PCT values ranged between 98%-100%. The results of this study confirm that Access PCT displays excellent analytical performance and high comparability with BRAHMS PCT-sensitive Kryptor.
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Lippi et al. (2020) studied this question. Beckman Coulter Access procalcitonin (PCT) chemiluminescent test vs. BRAHMS PCT-sensitive Kryptor was evaluated on Comparability of values (correlation and bias) (r = 0.999, p=< 0.001). The Beckman Coulter Access procalcitonin assay demonstrated excellent correlation (r = 0.999; p < 0.001) and negligible bias (3.2%) when compared to the BRAHMS PCT-sensitive Kryptor assay.
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