title: Cell Population Data and reflex testing rules of cell analysis in pleural and ascitic fluids using body fluid mode on Sysmex XN-9000.
abstract: BACKGROUND
  Although optical microscopy (OM) remains the reference technique for analysis of ascitic (AF) and pleural (PF) fluids, novel hematological analyzers are equipped with modules for body fluid (BF) analysis. This study was aimed to analyze the performance of XN-BF module in Sysmex XN-9000, and to develop validation rules for automated cell counts in BFs.
  
  
  METHODS
  The evaluation of XN-BF module included assessment of carryover, Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, data comparison with OM, and development of rules for assisting the validation of automated analysis of BFs and activating reflex testing.
  
  
  RESULTS
  The carryover was negligible. The LoB, LoD, LoQ and linearity were always excellent. The comparison with OM was characterized by Pearson's correlations ranging from r=0.50 to r=0.99 (p<0.001), modest bias and high diagnostic concordance (Area Under the Curve between 0.85 and 0.99). The use of instrument-specific cut-offs further increased diagnostic concordance. The implementation of reflex testing rules based on XN-BF data increased sensitivity and specificity of BFs classification to 0.98 and 0.95.
  
  
  CONCLUSIONS
  Our results suggest that the XN-BF module on Sysmex-9000 may be a suitable alternative to OM for screening BF samples, especially when specific validation rules are used.
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy. Electronic address: sbuoro@hpg23.it.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Buoro
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Mecca
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Azzarà
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Seghezzi
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Dominoni
authors.affiliation: Chemical Chemistry Laboratory Hospital Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Crippa
authors.affiliation: CAM Laboratory. s.p.a. Monza, Italy.
authors.forename: Cosimo
authors.initials: C
authors.lastname: Ottomano
authors.affiliation: Section of Clinical Biochemistry, University of Verona, Verona, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
mesh_terms: D001202:Ascitic Fluid / Q000166:cytology*; D057205:Automation, Laboratory; D002452:Cell Count / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D006801:Humans; D035422:Pleural Cavity / Q000166:cytology*; D015203:Reproducibility of Results
keywords: Ascitic fluid; Automated cell count; Body fluid; Pleural fluid; Reflex testing rules; Sysmex XN