Evaluation of commercial enzyme immunoassays for detection of hepatitis delta antigen and anti-hepatitis delta virus (HDV) and immunoglobulin M anti-HDV antibodies

Abstract

Panels of hepatitis B virus surface antigen-positive sera from drug abusers were used to evaluate 14 commercial enzyme immunoassays from six companies for detecting hepatitis delta virus (HDV) markers. For detecting hepatitis delta virus antigen (HDAg), the Wellcome, Pasteur and Noctech assays had 100% sensitivity for all 42 HDAg-positive serum specimens that were confirmed in-house; the Organon reagents gave 59.5% sensitivity without detergent and 64.3% sensitivity with detergent, but there were 14 discrepant results with and without detergent. The Sorin assay detected HDAg in only 10 of the positive samples (23.8% sensitivity). For the detection of antibody to HDV (anti-HDV) all six commercial enzyme immunoassays were reactive with all 36 anti-HDV-positive specimens that were confirmed in-house. There were no false-positive results with the Wellcome, Noctech, or Sorin assay, but one specimen was false positive by the Organon assay. One HDAg-positive specimen gave a false anti-HDV-positive result in the Abbott assay and an equivocal result in the Pasteur assay (97.8% specificity). For the detection of immunoglobulin M anti-HDV, the Wellcome, Noctech, and Sorin assays agreed for the 38 positives confirmed in-house, except for one false negative with the Sorin test. We conclude that there has been a substantial improvement over previously evaluated assays in sensitivity and specificity of commercial assays for anti-HDV detection, and the sensitivities of immunoglobulin M anti-HDV assays are also comparable. However, there are still major differences in sensitivity among some assays for HDAg detection.

Delta hepatitis: molecular biology and clinical and epidemiological features.

“…Both studies conclude that expression of the 7S monomer appears to be an immunologic event specific for chronic HDV infections; thus, tests for 7S and 19S IgM anti-HD may be of value for differential diagnosis of acute and chronic infections. Two recent studies have compared the sensitivities and specificities of various commercially available kits for the markers of HDV infection (13,181). Both studies used sera from patients who were HBsAg positive.…”

“…Both studies used sera from patients who were HBsAg positive. In one study (181), classification of patients with HDV infection was determined by in-house assays and documented seroconversion to IgM or total anti-HD. The greatest differences were obtained with serologic assays for HDAg, with sensitivities ranging from 100 to 24% (181).…”

“…In one study (181), classification of patients with HDV infection was determined by in-house assays and documented seroconversion to IgM or total anti-HD. The greatest differences were obtained with serologic assays for HDAg, with sensitivities ranging from 100 to 24% (181). Anti-HDV assays had fewer discrepancies in sensitivities and specificities, with sensitivities ranging from 84 to 100% (13,181).…”

“…The greatest differences were obtained with serologic assays for HDAg, with sensitivities ranging from 100 to 24% (181). Anti-HDV assays had fewer discrepancies in sensitivities and specificities, with sensitivities ranging from 84 to 100% (13,181). Molecular cloning of the HDV RNA genome has permitted the application of an additional research tool for the diagnosis of HDV infection.…”

Hepatitis delta virus infection in a large cohort of chronic hepatitis B patients in Ethiopia

“…This difference could be due to a decline in the prevalence of HDV in the country, but it is also possible that older studies overestimated the HDV seroprevalence related to the nature of the samples and/or the assays used. Older serological assays had suboptimal sensitivity and specificity, and the lack of molecular diagnostic methods was a major limitation. In our own study, of the 25 plasma samples positive for HDV antibodies with the Diasorin kit, 19 were confirmed anti‐HDV‐positive with the Dia.Pro kit and 12 had active virus replication.…”