Abstract
BackgroundTo determine procalcitonin (PCT) levels in blood, a newly analyzer based on liquid-phase binding assay (LBA) was developed (micro-total analysis system, μTAS). We evaluated analytical and clinical performance of this system in comparison with autoanalyzer based on chemiluminescence enzyme immunoassay (CLEIA), which is widely-used but takes much longer time than LBA. MethodsA total of 518 serum samples from 28 patients undergoing hematopoietic stem cell transplantation were analyzed. The correlation between the 2 methods and the comparison of the each area under the receiver operating characteristics curve (AUC) for distinguishing bacterial or fungal infections from other events were evaluated. ResultsThe minimum detection limit of serum PCT levels by LBA was 0.02ng/ml. There was an excellent correlation between the two methods in all samples (r2=0.99), the samples obtained on days of fever onset (r2=0.99), and the samples collected in neutropenic state (r2=0.99). The AUC for detection of bacterial or fungal infection on the onset of fever was not significantly different between LBA and CLEIA (0.80 by LBA and 0.82 by CLEIA, P=0.19). ConclusionsThe PCT measurement using LBA was well correlated with conventional method based on CLEIA and had enough clinical performance to detect bacterial or fungal infection in clinical setting.
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