Development of a point-of-care assay system for measurement of presepsin (sCD14-ST)

Background: The 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. Methods: A fully automated PATHFAST (R) Presepsin assay system based on a chemiluminescent enzyme immunoassay was developed for detecting presepsin in human whole blood. Results: The 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 (R) 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. Conclusion: The PATHFAST (R) Presepsin assay performed well and can be used for point-of-care. (C) 2011 Elsevier B.V. All rights reserved.