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 journalArticle

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.

Original languageEnglish
Pages (from-to)644-648
Number of pages5
JournalJournal of Hepatology
Volume25
Issue number5
DOIs
Publication statusPublished - Nov 1996

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Chronic Hepatitis B
Hepatitis B
Hepatitis B e Antigens
Hepatitis B Surface Antigens
Immunoenzyme Techniques
ROC Curve
anti-IgM
Liver Diseases
Healthy Volunteers
Control Groups
DNA
Infection
Serum

Keywords

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

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Quantitative analysis of IgM anti-HBc in chronic hepatitis B patients using a new 'gray-zone' for the evaluation of 'borderline' values. / Colloredo, Guido; Bellati, Giorgio; Leandro, Gioacchino; Colombatto, Piero; Anna, Rho; Bissoli, Franco; Brunetto, Maurizia Rossana; Angeli, Giovanni; Ideo, Gaetano; Bonino, Ferruccio.

In: Journal of Hepatology, Vol. 25, No. 5, 11.1996, p. 644-648.

Research output: Contribution to journalArticle

Colloredo, G, Bellati, G, Leandro, G, Colombatto, P, Anna, R, Bissoli, F, Brunetto, MR, Angeli, G, Ideo, G & Bonino, F 1996, 'Quantitative analysis of IgM anti-HBc in chronic hepatitis B patients using a new 'gray-zone' for the evaluation of 'borderline' values', Journal of Hepatology, vol. 25, no. 5, pp. 644-648. https://doi.org/10.1016/S0168-8278(96)80233-9
Colloredo, Guido ; Bellati, Giorgio ; Leandro, Gioacchino ; Colombatto, Piero ; Anna, Rho ; Bissoli, Franco ; Brunetto, Maurizia Rossana ; Angeli, Giovanni ; Ideo, Gaetano ; Bonino, Ferruccio. / Quantitative analysis of IgM anti-HBc in chronic hepatitis B patients using a new 'gray-zone' for the evaluation of 'borderline' values. In: Journal of Hepatology. 1996 ; Vol. 25, No. 5. pp. 644-648.
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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.",
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author = "Guido Colloredo and Giorgio Bellati and Gioacchino Leandro and Piero Colombatto and Rho Anna and Franco Bissoli and Brunetto, {Maurizia Rossana} and Giovanni Angeli and Gaetano Ideo and Ferruccio Bonino",
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T1 - Quantitative analysis of IgM anti-HBc in chronic hepatitis B patients using a new 'gray-zone' for the evaluation of 'borderline' values

AU - Colloredo, Guido

AU - Bellati, Giorgio

AU - Leandro, Gioacchino

AU - Colombatto, Piero

AU - Anna, Rho

AU - Bissoli, Franco

AU - Brunetto, Maurizia Rossana

AU - Angeli, Giovanni

AU - Ideo, Gaetano

AU - Bonino, Ferruccio

PY - 1996/11

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N2 - 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.

AB - 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.

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KW - Hepatitis B virus

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