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

Abstract:

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.

journal_name

J Hepatol

journal_title

Journal of hepatology

authors

Colloredo G,Bellati G,Leandro G,Colombatto P,Rho A,Bissoli F,Brunetto MR,Angeli G,Ideo G,Bonino F

doi

10.1016/s0168-8278(96)80233-9

subject

Has Abstract

pub_date

1996-11-01 00:00:00

pages

644-8

issue

5

eissn

0168-8278

issn

1600-0641

pii

S0168-8278(96)80233-9

journal_volume

25

pub_type

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