Performance comparison of the LIAISON Murex Anti-HEV IgG/IgM and the Elecsys Anti-HEV IgG/IgM assays for the detection of hepatitis E virus infection.

BACKGROUND

Hepatitis E virus (HEV) infection is the leading cause of acute viral hepatitis globally.

OBJECTIVES

We compared the performance of the two fully-automated anti-HEV IgM and IgG assays available: The LIAISON XL murex assay (DiaSorin) and the newly introduced Elecsys® Anti-HEV IgG and Elecsys Anti-HEV IgM assays (Roche Diagnostics).

STUDY

DESIGN

The study included n = 1808 samples tested across three testing sites. Overall percentage agreement (OPA), relative sensitivity, and specificity were calculated using a multi-comparator approach with CE-IVD-marked assays (recomWell, Wantai, and Vidas) as reference.

RESULTS

OPA between Murex and Elecsys assays was 97.9% (95%-CI: 97.1-98.5%) and 93.9% (95%-CI: 92.6-95.0) for the detection of anti-HEV IgM and IgG, respectively, and kappa (κ) was κ= 0.94 (95%-CI: 0.92-0.96) and κ= 0.86 (95%-CI: 0.85-0.90). Using clinical samples from HEV RNA-positive (n = 216), acute (n = 338), and resolved infections (n = 156), relative sensitivity was determined as > 95.7% for the Murex and > 98.6% for the Elecsys assay. Relative specificity was > 98.8% for the Murex and > 89.7% for the Elecsys assays, as determined using samples from asymptomatic blood donors (n = 500), routine diagnostic samples with clinical suspicion of viral hepatitis (n = 498), and pregnant women (n = 100). Of n = 47 anti-HEV IgG Elecsys-only reactive samples, 95.7% (n = 45/47) were confirmed by neutralization, increasing relative specificity to 98.8%.

CONCLUSION

Both assays demonstrated high agreement across comprehensive clinical cohorts. Notably, the Elecsys Anti-HEV IgG assay showed higher sensitivity for anti-HEV-IgG detection, which may have implications for immunity estimates and seroprevalence studies. Overall, both assays appear well suited to meet the growing demand for HEV diagnostics.