Quantification of hepatitis B surface antigen with the novel DiaSorin LIAISON XL Murex HBsAg Quant: Correlation with the ARCHITECT quantitative assays

•HBsAg quantitative assessment is useful to monitor chronic HBV hepatitis.•We assessed performances of the new CE launched quantitative HBsAg LIAISON-XL.•ARCHITECT-quantitative test was used as reference.•LIAISON-XL was highly correlated with ARCHITECT and the 2nd WHO Standard.•LIAISON-XL accurately quantifies HBsAg and can be applied in clinical practice.

BackgroundRecent 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.ObjectivesTo compare LIAISON-XL performances with ARCHITECT-QT HBsAg (Abbott Diagnostics, IL, USA), as reference test.Study designSequential 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.ResultsLIAISON-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 log10 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).ConclusionsCorrelation 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.