title: Clinical comparison of QUANTA Flash dsDNA chemiluminescent immunoassay with four current assays for the detection of anti-dsDNA autoantibodies.
abstract: BACKGROUND
  The objective of the present study was to compare QUANTA Flash dsDNA, a chemiluminescent immunoassay (CIA) on the BIO-FLASH, a rapid-response chemiluminescent analyzer, to three other anti-dsDNA antibody assays and to Crithidia luciliae indirect immunofluorescence test (CLIFT).
  
  
  METHODS
  In the first part of the study, 161 samples, 61 from patients suffering from systemic lupus erythematosus (SLE) and 100 from a disease control group, were tested by QUANTA Flash dsDNA CIA, QUANTA Lite dsDNA SC ELISA, BioPlex 2200 multiplex flow immunoassay (MFI), ImmuLisa dsDNA ELISA, and NOVA Lite CLIFT. A second cohort of 69 SLE patients was then tested by QUANTA Flash dsDNA and CLIFT to expand the study.
  
  
  RESULTS
  The overall qualitative agreements varied between 77.0% (NOVA Lite CLIFT versus QUANTA Lite) and 89.4% (ImmuLisa versus NOVA Lite CLIFT). The clinical sensitivities for the anti-dsDNA antibody tests varied from 8.2% (NOVA Lite CLIFT) to 54.1% (QUANTA Lite), while the clinical specificities varied from 88.0% (BioPlex 2200) to 100.0% (NOVA Lite CLIFT). Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT.
  
  
  CONCLUSIONS
  Significant variations among dsDNA methods were observed. QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.
authors.affiliation: Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Infantino
authors.affiliation: Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Meacci
authors.affiliation: Inova Diagnostics, Inc., San Diego, CA 92131, USA.
authors.forename: Chelsea
authors.initials: C
authors.lastname: Bentow
authors.affiliation: Inova Diagnostics, Inc., San Diego, CA 92131, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Martis
authors.affiliation: UO Reumatologia, Ospedale S. Giovanni di Dio, 3055 69321 Firenze, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Benucci
authors.affiliation: UOC Medicina Clinica e Reumatologia, Università Campus Bio-Medico, Via Álvaro del Portillo 21, Roma, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Afeltra
authors.affiliation: UOC Medicina Clinica e Reumatologia, Università Campus Bio-Medico, Via Álvaro del Portillo 21, Roma, Italy.
authors.forename: Amelia
authors.initials: A
authors.lastname: Rigon
authors.affiliation: UOC Reumatologia, Ospedale L. Sacco Polo Universitario, Via Giovanni Battista Grassi 74, 20157 Milano, Italy.
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.affiliation: UOC Reumatologia, Ospedale L. Sacco Polo Universitario, Via Giovanni Battista Grassi 74, 20157 Milano, Italy.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Manfredi
authors.affiliation: Inova Diagnostics, Inc., San Diego, CA 92131, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Mahler
mesh_terms: D000974:Antibodies, Antinuclear / Q000097:blood*; D016022:Case-Control Studies; D016000:Cluster Analysis; D005455:Fluorescent Antibody Technique / Q000379:methods / Q000592:standards; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000097:blood* / Q000175:diagnosis*; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000974:Antibodies, Antinuclear