title: Development of a point-of-care assay system for measurement of presepsin (sCD14-ST).
abstract: 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® 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® 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.
  
  
  CONCLUSIONS
  The PATHFAST® Presepsin assay performed well and can be used for point-of-care.
authors.affiliation: Research and Development Division, Mitsubishi Chemical Medience Corporation, Japan. okamura.yoshikazu@ma.medience.co.jp
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Okamura
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yokoi
mesh_terms: D006801:Humans; D057230:Limit of Detection; D018950:Lipopolysaccharide Receptors / Q000032:analysis*; D019095:Point-of-Care Systems; D015203:Reproducibility of Results
chemical_list: D018950:Lipopolysaccharide Receptors