title: Detection of anti-dsDNA antibodies by computer-aided automated immunofluorescence analysis.
abstract: NOVA View is a computer aided fluorescence microscope that is used for the automated reading and interpretation of indirect immunofluorescent tests in diagnostic immunology. The objective of the present study was to evaluate the performance of the NOVA View® system for the measurement of anti-dsDNA antibodies using the Crithidia luciliae indirect immunofluorescence test (CLIFT) technology.
  
  
  
  Analytical performance of NOVA View CLIFT was assessed in repeatability (within run) and reproducibility (between runs and instruments) studies. Two hundred-fifty patient samples (N=200 consecutive samples and N=50 samples from systemic lupus erythematosus patients) were tested to evaluate the agreement between results generated with NOVA View CLIFT, and those obtained with manual microscopic reading of the same slides. Positivity rate in SLE was assessed on the 50 SLE samples.
  
  
  
  The NOVA View system showed high level of repeatability and reproducibility within runs, between runs, and between instruments. Agreement of NOVA View software interpretation and digital image reading results with manual microscopic reading results was 96.0%, and the same positivity rate was obtained on SLE samples by NOVA View digital image reading as that of manual microscopic reading (36.0% vs. 38.0%, respectively).
  
  
  
  Results generated by NOVA View CLIFT were equivalent to those obtained by manual microscopic reading on a large routine sample set. NOVA View demonstrated consistency within and between runs, and between instruments. Automation of CLIFT provides reliability and is a suitable alternative for routine clinical laboratories.
authors.affiliation: Inova Diagnostics, Inc, San Diego, CA, USA.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Lakos
authors.affiliation: Inova Diagnostics, Inc, San Diego, CA, USA.
authors.forename: Marlene
authors.initials: M
authors.lastname: Gonzalez
authors.affiliation: Inova Diagnostics, Inc, San Diego, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Flaherty
authors.affiliation: Inova Diagnostics, Inc, San Diego, CA, USA. Electronic address: cbentow@inovadx.com.
authors.forename: Chelsea
authors.initials: C
authors.lastname: Bentow
authors.affiliation: Exagen Diagnostics, Vista, CA, USA.
authors.forename: Claudia
authors.initials: C
authors.lastname: Ibarra
authors.affiliation: Exagen Diagnostics, Vista, CA, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Stimson
authors.affiliation: Exagen Diagnostics, Vista, CA, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Nacario
authors.affiliation: Faculty of Natural Sciences, Brandenburg University of Technology Cottbus-Senftenberg, Senftenberg, Germany.
authors.forename: Rico
authors.initials: R
authors.lastname: Hiemann
authors.affiliation: Exagen Diagnostics, Vista, CA, USA.
authors.forename: Thierry
authors.initials: T
authors.lastname: Dervieux
mesh_terms: D000974:Antibodies, Antinuclear / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D019084:Fluorescent Antibody Technique, Indirect / Q000379:methods*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis; D008856:Microscopy, Fluorescence / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012984:Software
chemical_list: D000974:Antibodies, Antinuclear; D011933:Reagent Kits, Diagnostic
keywords: Autoantibodies; Crithidia luciliae; Indirect immunofluorescence; Systemic lupus erythematosus; dsDNA