Quantitative analysis of IgM anti-HBc in chronic hepatitis B patients using a new 'gray-zone' for the evaluation of 'borderline' values

Guido Colloredo, Giorgio Bellati, Gioacchino Leandro, Piero Colombatto, Rho Anna, Franco Bissoli, Maurizia Rossana Brunetto, Giovanni Angeli, Gaetano Ideo, Ferruccio Bonino

Research output: Contribution to journalArticlepeer-review


Background/Methods: In order to define the clinical significance of borderline levels of IgM anti-HBc in chronic hepatitis B patients, we followed up 89 untreated hepatitis B patients (19 HBeAg pos and 70 anti-HBe pos) for 1 year, with monthly monitoring of IgM anti-HBc using a highly sensitive quantitative microparticle enzyme immunoassay (IMx CORE-M, Abbott). As a control group we used 304 healthy subjects: 150 HBsAg negative and anti-HBc/anti-HBs positive, and 154 without markers of HBV infection. The statistical analysis performed by Receiver Operating Characteristic curve indicated the 100% sensitivity cut-off at 0.081 IMx index and 100% specificity cut-off at 0.358 IMx index. Results: We could define the range of a chronic hepatitis B 'gray-zone' between 0.100 [80.6% specificity (95% CI, 76.2%-85%), 96.6% sensitivity (95% CI, 92.8%-100%)] and 0.200 [95.7% specificity (95% CI, 93.4%-98%) and 78.7% sensitivity (95% CI, 70.2%-87.2%)] of the IgM anti-HBc-IMx index. In fact, none of the chronic hepatitis B patients had IgM anti-HBc-IMx values persistently below 0.100 during the follow-up, whereas 57.3% had values persistently higher than 0.200. In 38.2%, IgM anti-HBc values occasionally fell within the 'gray-zone' limits. In the remaining four patients (4.4%), the results overlapped the 'gray-zone' values. Conclusions: These results suggest that the use of a chronic hepatitis B 'gray-zone' for values of quantitative IgM anti-HBc assays helps to distinguish 'true healthy carriers' from asymptomatic chronic anti-HBe positive hepatitis B patients who have been shown to have temporary remissions of liver disease and frequently undetectable serum HBV-DNA.

Original languageEnglish
Pages (from-to)644-648
Number of pages5
JournalJournal of Hepatology
Issue number5
Publication statusPublished - Nov 1996


  • Chronic hepatitis B
  • Hepatitis B virus
  • IgM anti-HBc

ASJC Scopus subject areas

  • Gastroenterology


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