Abstract
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.
Highlights
Procalcitonin (PCT) is the 116 amino acid precursor of the active hormone calcitonin, which is almost uniquely synthesized by thyroid C cells under physiological conditions, and displays plasma concentrations
In response to proinflammatory triggers, especially bacterial products, a sustained extra-thyroid production occurs, mostly from the leukocytes, liver, lung, intestine and kidney, enhancing its circulating levels by several orders of magnitude, occasionally over 100 μg/L [1,2,3]. This paradigmatic biological event, which was first documented by Wagner and colleagues in 1981 [4], was exploited by Marcel Assicot et al for demonstrating that measuring PCT may be a valuable aid for diagnosing severe bacterial infections [5]
The number of PCT immunoassays available in the market is constantly increasing in parallel with the andofmultifaceted diagnostic applications this biomarker
Summary
Procalcitonin (PCT) is the 116 amino acid precursor of the active hormone calcitonin, which is almost uniquely synthesized by thyroid C cells under physiological conditions, and displays plasma concentrations
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