title: Evaluation of procalcitonin with liquid-phase binding assay in hematological malignancy.
abstract: 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.
authors.affiliation: Department of Hematology & Oncology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Koya
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Nannya
authors.forename: Mineo
authors.initials: M
authors.lastname: Kurokawa
mesh_terms: D019540:Area Under Curve; D001424:Bacterial Infections / Q000097:blood* / Q000150:complications / Q000175:diagnosis; D001681:Biological Assay; D002116:Calcitonin / Q000097:blood*; D015740:Calcitonin Gene-Related Peptide; D003937:Diagnosis, Differential; D005334:Fever / Q000097:blood* / Q000150:complications / Q000175:diagnosis; D019337:Hematologic Neoplasms / Q000097:blood* / Q000150:complications / Q000175:diagnosis; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007124:Immunoenzyme Techniques; D057230:Limit of Detection; D009181:Mycoses / Q000097:blood* / Q000150:complications / Q000175:diagnosis; D011498:Protein Precursors / Q000097:blood*; D012680:Sensitivity and Specificity
chemical_list: C000606589:CALCA protein, human; D011498:Protein Precursors; D002116:Calcitonin; D015740:Calcitonin Gene-Related Peptide