Summary auto-generated
Researchers evaluated 47 serum samples positive for hepatitis B surface antigen and core antibody using five commercially available ELISA kits to test for hepatitis B "e" antigen and "e" antibody. These markers are clinically important because "e" antigen presence indicates high viral load and infectivity, while "e" antibody indicates lower risk of transmission. Testing revealed substantial disagreement between different assay kits: of 16 samples tested by all five kits, only three showed consistent results across all tests. Additional testing of 20 and 11 sera by four and three assays respectively also showed significant discordance. Hepatitis B DNA testing failed to resolve these inconsistencies, with some samples negative for "e" antigen by all methods yet positive for hepatitis B DNA. The authors emphasize that reliable "e" status determination is crucial for patient management, hospital infection control, and UK Department of Health guidelines governing safe practice by hepatitis B-infected healthcare workers. The absence of standardized reference sera and official guidance on kit sensitivity and specificity creates serious clinical implications, potentially leading to incorrect infectivity assessments.
Key findings
- Significant discordance was observed between different commercial ELISA kits for detecting hepatitis B "e" antigen and antibody, with only 3 of 16 samples showing concordant results across all five kits tested
- Hepatitis B DNA testing did not resolve the discrepancies between serological markers, with some samples negative for "e" antigen by all methods yet positive for hepatitis B DNA
- The lack of standardized reference sera and official guidance on assay sensitivity/specificity undermines the reliability of "e" status determination, with major implications for patient care and healthcare worker employment restrictions
- One case demonstrated clinical danger: a carrier with discordant "e" status results had hepatitis B DNA and infected multiple sexual partners, despite some assays suggesting lower infectivity
This summary was generated automatically from the article PDF and is not part of the original publication. Refer to the PDF for the authoritative text.
Abstract
Forty-seven sera that gave positive results in tests for hepatitis B surface antigen and core antibody were examined for the presence of "e" antigen and "e" antibody by various commercially available assays. Considerable discordance was observed between results of tests performed on the same sample in different assays. Examination of the sera for the presence of hepatitis B DNA failed to resolve the discrepancies. Increasingly, "e" antigen and its antibody are used as measures of infectivity in carriers of hepatitis B. The absence of reliable tests has implications for patients, for infection control within hospitals and for the implementation of Department of Health guidelines on safe working practices for hepatitis B-infected health care workers.