Diagnostic Performance of an Automated System for Assaying Anti-Hepatitis E Virus Immunoglobulins M and G Compared with a Conventional Microplate Assay

Abstract

To evaluate the diagnostic performance of the Liaison® Murex anti-HEV IgM and IgG assays running on the Liaison® instrument and compare the results with those obtained with Wantai HEV assays. We tested samples collected in immunocompetent and immunocompromised patients during the acute (HEV RNA positive, anti-HEV IgM positive) and the post-viremic phase (HEV RNA negative, anti-HEV IgM positive) of infections. The specificity was assessed by testing HEV RNA negative/anti-HEV IgG-IgM negative samples. The clinical sensitivity of the Liaison® IgM assay was 100% for acute-phase samples (56/56) and 57.4% (27/47) for post-viremic samples from immunocompetent patients. It was 93.8% (30/32) for acute-phase (viremic) samples and 71%% (22/31) for post-viremic samples from immunocompromised patients. The clinical sensitivity of the Liaison® IgG assay was 100% for viremic samples (56/56) and 94.6% (43/47) for post-viremic samples from immunocompetent patients. It was 84.3% (27/32) for viremic samples and 93.5% (29/31) for post-viremic samples from immunocompromised patients. Specificity was very high (>99%) in both populations. We checked the limit of detection stated for the Liaison® IgG assay (0.3 U/mL). The clinical performance of the Liaison® ANTI-HEV assays was good. These rapid, automated assays for detecting anti-HEV antibodies will greatly enhance the arsenal for diagnosing HEV infections.

Assessment of the Diagnostic Performance of Fully Automated Hepatitis E Virus (HEV) Antibody Tests

“…A total of 8 of the 17 samples found to be reactive by the recom Well HEV IgM ELISA were concordantly negative by the recom Line HEV IgM blot and by the DiaSorin and WANTAI IgM assays ( Table 3 ). Recently, good agreement was reported between HEV antibody tests from the latter two manufacturers [ 10 ]. The indices of samples No.…”

“…The sera were retested with the fully automated chemiluminescence immunoassays (CLIAs) LIAISON ® MUREX Anti-HEV IgG (DiaSorin Italia S.p.A., Saluggia, Italy; quantitative; positive ≥ 0.3 IU/mL) and LIAISON ® MUREX Anti-HEV IgM (qualitative; index ≥ 1.00), which use the gt 1 and 3 capsid proteins as antigens [ 10 ]. Available data from some patients with acute infection by HEV gt 1, 2 and 4 show that these tests can reliably detect the corresponding antibodies [ 10 ].…”

“…With few exceptions, most of the available tests for the detection of HEV antibodies are performed manually in an enzyme-linked immunoassay (ELISA) format [ 9 ]. DiaSorin has recently launched fully automated high-throughput tests for the detection of anti-HEV IgG and IgM antibodies [ 10 ]. The aim of this study was to evaluate the performance of the DiaSorin LIAISON ® MUREX Anti-HEV IgG and IgM assays in comparison with the established and widely used recom Well/ recom Line HEV IgG and IgM ELISAs/immunoblots from MIKROGEN.…”

Hepatitis E Prevalence in Vulnerable Populations in Goiânia, Central Brazil

“…To the best of our knowledge, only one study has previously evaluated these new assays to date. Recently, Abravanel et al [ 31 ] reported that the Liaison ® Murex assays are very sensitive and specific in comparison to the Wantai HEV assays, observing a rate of sensitivity of 100% for IgM and IgG assays with acute-phase samples from immunocompetent patients, although less for IgM (93.8%) and IgG (84.3%) assays obtained from immunocompromised patients. In addition, a sensitivity of 94.6% was observed for anti-HEV IgG and 57.4% for anti-HEV IgM using post-viremic samples from immunocompetent patients, which in turn was 93.5% and 71% for immunocompromised patients.…”

Hepatitis E Virus (HEV) Infection among Hemodialysis Patients from Southern Bulgaria

“…The anti-HEV ELISA IgG has a linearity range of 1 IU/mL to 22 IU/mL with a detection limit of 0.1 IU/mL. Considering the variations in sensitivity among diverse commercial diagnostic kits for detecting HEV antibodies [13], the diagnostic assay was chosen based on specificity instead of sensitivity. The Euroimmun was selected based on its established high specificity of 100% for anti-HEV IgM and 99.3% for anti-HEV IgG in patients lacking markers of HEV infection, as observed in our study population [14].…”