title: Quantification of hepatitis B surface antigen with the novel DiaSorin LIAISON XL Murex HBsAg Quant: correlation with the ARCHITECT quantitative assays.
abstract: BACKGROUND
  Recent technologic innovations allow for quantitative assessment of hepatitis B surface antigen (HBsAg) levels in serum; this has been used to monitor the course of chronic HBV hepatitis (CHB) and predict treatment response. LIAISON-XL Murex HBsAg Quant assay (DiaSorin, Saluggia, I) is the newest immunoassay CE approved to quantify HBsAg.
  
  
  OBJECTIVE
  To compare LIAISON-XL performances with ARCHITECT-QT HBsAg (Abbott Diagnostics, IL, USA), as reference test.
  
  
  METHODS
  Sequential serum samples (n=152) from 14 HBe-negative patients with CHB, the majority of them infected by HBV genotype D undergoing antiviral treatment, were retrospectively tested with both assays. The 2nd WHO Standard 00/588 for HBsAg was used as reference.
  
  
  RESULTS
  LIAISON-XL and ARCHITECT-QT correlated by r=0.95, p<0.0001; by Bland-Altman analysis agreement of mean difference was 0.21 ± 0.15 log 10 IU/mL, 95% CI: -0.07 to 0.5). Performance of LIAISON-XL against the 2nd WHO Standard was r=0.998, p<0.0001 (95% CI: 0.993-0.999) with results nearer to the expected WHO values compared to ARCHITECT-QT. Median baseline HBsAg level was similar with the two methods before antiviral treatment, throughout fluctuations of HBsAg level in treatment non-responders and during the decrease of HBsAg titer in treatment responders. Correlation between HBsAg levels and HBV DNA was statistically significant for both the two immunoassays (LIAISON-XL: r=0.4988, 95% CI: 0.3452-0.6264, p<0.0001; ARCHITECT-QT: r=0.480, 95% CI: 0.3233-0.6111, p<0.0001).
  
  
  CONCLUSIONS
  Correlation between HBsAg measurement with LIAISON-XL and ARCHITECT-QT was high. LIAISON-XL accurately quantified HBsAg in clinical samples at baseline or during antiviral therapy; it can be applied for HBsAg quantification in clinical practice and decision making in CHB.
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Torino, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Burdino
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Torino, Italy.
authors.forename: Tina
authors.initials: T
authors.lastname: Ruggiero
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Torino, Italy.
authors.forename: Alex
authors.initials: A
authors.lastname: Proietti
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Torino, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Milia
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Olivero
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Caviglia
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Milena
authors.initials: M
authors.lastname: Marietti
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Antonina
authors.initials: A
authors.lastname: Smedile
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Torino, Italy. Electronic address: valeria.ghisetti@gmail.com.
authors.forename: Valeria
authors.initials: V
authors.lastname: Ghisetti
mesh_terms: D015415:Biomarkers / Q000097:blood; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000097:blood* / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D012189:Retrospective Studies; D019562:Viral Load
chemical_list: D015415:Biomarkers; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens
keywords: ARCHITECT-QT; HBsAg quantitative; LIAISON-XL