Diagnostic value of anti-hepatitis D virus (HDV) antibodies revisited: a study of total and IgM anti-HDV compared with detection of HDV-RNA by polymerase chain reaction.

A high serum titre (> or = 1000 or > or = 5000) of total antibody to hepatitis D virus (anti-HDV) and positive for immunoglobulin (Ig)M anti-HDV have been used to represent HDV replication, while reverse transcription-polymerase chain reaction (RT-PCR) is currently the most sensitive assay for detecting HDV viraemia. The aim of the present study was to re-evaluate the correlation of total anti-HDV and IgM anti-HDV with HDV viraemia based on RT-PCR and to assess the clinical significance of these markers in acute and chronic HDV superinfection. Chronic HDV infection was defined as positive HDV-RNA by RT-PCR for more than 6 months, while total anti-HDV titre was defined by serial dilution. Of 178 hepatitis B virus (HBV) carrier patients studied, 119 cases had been anti-HDV positive for more than 6 months. Two-thirds (79/119) were positive for HDV viraemia by RT-PCR. Only half the chronic HDV viraemic patients had a high titre (> or = 1000) of total anti-HDV, and there was only moderate agreement (kappa = 0.41) between total anti-HDV titre/IgM anti-HDV and HDV-RNA and chronic HDV viraemia. Based on cross-sectional and longitudinal follow-up analyses, serum total anti-HDV titres > or = 100 appeared to be an excellent cut-off titre (kappa = 0.91) in differentiating chronic from acute HDV infection among viraemic patients. In summary, IgM and a high titre total of anti-HDV are not good markers of HDV viraemia, but an anti-HDV titre of > or = 100 appears to be an excellent marker for the differentiation of acute from chronic HDV superinfection.