Background: To 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.
Methods: A 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.
Results: The minimum detection limit of serum PCT levels by LBA was 0.02 ng/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).
Conclusions: The 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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