Clinical performance of the novel DiaSorin LIAISON® XL murex: HBsAg Quant, HCV-Ab, HIV-Ab/Ag assays

Abstract Background The fully automated and closed LIAISON® XL platform was developed for reliable detection of infection markers like hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab) or human immunodeficiency virus (HIV)-Ag/Ab. To date, less is known about the diagnostic performance of this system in direct comparison to the common Abbott ARCHITECT® platform. Objectives We compared the diagnostic performance and usability of the DiaSorin LIAISON® XL with the commonly used Abbott ARCHITECT® system. Study design The qualitative performance of the above mentioned assays was compared in about 500 sera. Quantitative tests were performed for HBsAg-positive samples from patients under therapy ( n = 289) and in vitro expressed mutants ( n = 37). For HCV-Ab, a total number of 155 selected samples from patients chronically infected with different HCV genotypes were tested. Results The concordance between both systems was 99.4% for HBsAg, 98.81% for HCV-Ab, and 99.6% for HIV-Ab/Ag. The quantitative LIAISON® XL murex HBsAg assay detected all mutants in comparable amounts to the HBsAg wild type and yielded highly reliable HBsAg kinetics in patients treated with antiviral drugs. Dilution experiments using the 2nd International Standard for HBsAg (WHO) showed a high accuracy of this test. HCV-Ab from patients infected with genotypes 1–3 were equally detected in both systems. Interestingly, S/CO levels of HCV-Ab from patients infected with genotype 3 seem to be relatively low using both systems. Conclusions The LIAISON® XL platform proved to be an excellent system for diagnostics of HBV, HCV, and HIV with equal performance compared to the ARCHITECT® system.