• Yoshikazu Okamura and Hiroyuki Yokoi.
• Research and Development Division, Mitsubishi Chemical Medience Corporation, Japan. okamura.yoshikazu@ma.medience.co.jp
• Clin. Chim. Acta. 2011 Nov 20;412(23-24):2157-61.

BackgroundThe soluble CD14 subtype (sCD14-ST: renamed as presepsin) is a novel soluble CD14 molecule that is useful for diagnosing sepsis because sCD14-ST levels increase specifically in sepsis patients.MethodsA fully automated PATHFAST® Presepsin assay system based on a chemiluminescent enzyme immunoassay was developed for detecting presepsin in human whole blood.ResultsThe limit of blank, limit of detection, and limit of quantification were 2.33, 13.4, and 47.6 pg/ml, respectively. The assay linearity was achieved up to 20,000 pg/ml. Intra-assay imprecision was 3.4-4.8% for plasma and 2.7-7.1% for whole blood. Within-run imprecision and total imprecision for plasma were 3.6-4.4% and 5.2-6.5%, respectively. No interference was observed with bilirubin, hemoglobin, lipids, triglyceride, or rheumatoid factors. The reference intervals (95% percentile, n=127) were 333 pg/ml for plasma and 314 pg/ml for whole blood. The PATHFAST® Presepsin assay correlated well with a previously reported two-step presepsin ELISA (r=0.984, n=40). Furthermore, the concentration of presepsin was significantly higher in the sepsis group than in the healthy group.ConclusionThe PATHFAST® Presepsin assay performed well and can be used for point-of-care.Copyright © 2011 Elsevier B.V. All rights reserved.

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