The reliability of HBV core antibody in serological screening for hepatitis B virus

Fatma Ba Alawi, Peter W. Robertson, Amelia K. Lepage, Jude Jayamaha, Cristina Baleriola, William D. Rawlinson

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Introduction: Accurate diagnosis of hepatitis B virus (HBV) infection is essential for infection control, treatment and screening of potential blood, organ and tissue donors. We assessed the sensitivity of the HBsAg and HBcAb as screening assays alone and in combination for detecting HBV infection in a series of Australian patients. The performance of the Architect (Abbott Diagnostics, Germany) and the Elecsys (Roche Diagnostics, Germany) platforms were assessed for detection of HBcAb. Methods: There were 2778 blood samples assessed using the COBAS Ampliprep/TaqMan test for HBV DNA, of which 331 sera had concurrent HBV serology testing. This allowed determination of the correlation between HBV DNA and different serological markers. Of the 331 sera, 260 had sufficient residual volume to be retested for HBcAb using both Elecsys and the Architect assays. Results: Of the 331 patients, one (0.3%) was negative by the Architect Anti-HBc II assay, in the presence of HBV DNA and positive HBsAg, consistent with recent infection. Positive HBcAb in the absence of HBV DNA was found in 67 of 331 (20.2%) patients. Of these, 18 of 67 had isolated HBcAb with negative results on all other tests, with 12 of 18 (3.6%) demonstrating low HBcAb signals on chemiluminscent microparticle assay. No cases of detectable HBV DNA in the presence of negative serology were found. When the HBcAb was used as a marker for past exposure or chronic HBV infection, the Architect Anti-HBc II assay demonstrated sensitivity and specificity of 98% and 79.9%, respectively, compared to 90% and 78.9%, respectively, for the Elecsys Anti-HBc assay. The combination of the Architect Anti-HBc II and HBsAg assays, as per conventional solid organ donor and recipient screening protocols, had 90% specificity and 100% sensitivity for determining HBV infection. Conclusion: This study shows that the use of combined HBsAg and HBcAb is sensitive and reliable for screening and predicting HBV nucleic acid test (NAT) positivity, whereas HBcAb alone missed an acute infection in this study population. There were no significant differences detectable between the Architect and the Elecsys HBcAb assays ( p=0.001), suggesting laboratories should assess individual assays in the local population before use as screening tests.

Original languageEnglish
Pages (from-to)501-505
Number of pages5
JournalPathology
Volume45
Issue number5
DOIs
Publication statusPublished - 2013

Fingerprint

Hepatitis B Antibodies
Hepatitis B virus
Virus Diseases
Hepatitis B Surface Antigens
DNA
Tissue Donors
Serology
Germany
Donor Selection
Sensitivity and Specificity
Residual Volume
Chronic Hepatitis B
Infection Control
Infection
Blood Donors
Serum
Nucleic Acids
Population

Keywords

  • HBcAb
  • HBsAg
  • HBV infection
  • HBV NAT
  • Organ donors

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Ba Alawi, F., Robertson, P. W., Lepage, A. K., Jayamaha, J., Baleriola, C., & Rawlinson, W. D. (2013). The reliability of HBV core antibody in serological screening for hepatitis B virus. Pathology, 45(5), 501-505. https://doi.org/10.1097/PAT.0b013e3283631cf9

The reliability of HBV core antibody in serological screening for hepatitis B virus. / Ba Alawi, Fatma; Robertson, Peter W.; Lepage, Amelia K.; Jayamaha, Jude; Baleriola, Cristina; Rawlinson, William D.

In: Pathology, Vol. 45, No. 5, 2013, p. 501-505.

Research output: Contribution to journalArticle

Ba Alawi, F, Robertson, PW, Lepage, AK, Jayamaha, J, Baleriola, C & Rawlinson, WD 2013, 'The reliability of HBV core antibody in serological screening for hepatitis B virus', Pathology, vol. 45, no. 5, pp. 501-505. https://doi.org/10.1097/PAT.0b013e3283631cf9
Ba Alawi, Fatma ; Robertson, Peter W. ; Lepage, Amelia K. ; Jayamaha, Jude ; Baleriola, Cristina ; Rawlinson, William D. / The reliability of HBV core antibody in serological screening for hepatitis B virus. In: Pathology. 2013 ; Vol. 45, No. 5. pp. 501-505.
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abstract = "Introduction: Accurate diagnosis of hepatitis B virus (HBV) infection is essential for infection control, treatment and screening of potential blood, organ and tissue donors. We assessed the sensitivity of the HBsAg and HBcAb as screening assays alone and in combination for detecting HBV infection in a series of Australian patients. The performance of the Architect (Abbott Diagnostics, Germany) and the Elecsys (Roche Diagnostics, Germany) platforms were assessed for detection of HBcAb. Methods: There were 2778 blood samples assessed using the COBAS Ampliprep/TaqMan test for HBV DNA, of which 331 sera had concurrent HBV serology testing. This allowed determination of the correlation between HBV DNA and different serological markers. Of the 331 sera, 260 had sufficient residual volume to be retested for HBcAb using both Elecsys and the Architect assays. Results: Of the 331 patients, one (0.3{\%}) was negative by the Architect Anti-HBc II assay, in the presence of HBV DNA and positive HBsAg, consistent with recent infection. Positive HBcAb in the absence of HBV DNA was found in 67 of 331 (20.2{\%}) patients. Of these, 18 of 67 had isolated HBcAb with negative results on all other tests, with 12 of 18 (3.6{\%}) demonstrating low HBcAb signals on chemiluminscent microparticle assay. No cases of detectable HBV DNA in the presence of negative serology were found. When the HBcAb was used as a marker for past exposure or chronic HBV infection, the Architect Anti-HBc II assay demonstrated sensitivity and specificity of 98{\%} and 79.9{\%}, respectively, compared to 90{\%} and 78.9{\%}, respectively, for the Elecsys Anti-HBc assay. The combination of the Architect Anti-HBc II and HBsAg assays, as per conventional solid organ donor and recipient screening protocols, had 90{\%} specificity and 100{\%} sensitivity for determining HBV infection. Conclusion: This study shows that the use of combined HBsAg and HBcAb is sensitive and reliable for screening and predicting HBV nucleic acid test (NAT) positivity, whereas HBcAb alone missed an acute infection in this study population. There were no significant differences detectable between the Architect and the Elecsys HBcAb assays ( p=0.001), suggesting laboratories should assess individual assays in the local population before use as screening tests.",
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N2 - Introduction: Accurate diagnosis of hepatitis B virus (HBV) infection is essential for infection control, treatment and screening of potential blood, organ and tissue donors. We assessed the sensitivity of the HBsAg and HBcAb as screening assays alone and in combination for detecting HBV infection in a series of Australian patients. The performance of the Architect (Abbott Diagnostics, Germany) and the Elecsys (Roche Diagnostics, Germany) platforms were assessed for detection of HBcAb. Methods: There were 2778 blood samples assessed using the COBAS Ampliprep/TaqMan test for HBV DNA, of which 331 sera had concurrent HBV serology testing. This allowed determination of the correlation between HBV DNA and different serological markers. Of the 331 sera, 260 had sufficient residual volume to be retested for HBcAb using both Elecsys and the Architect assays. Results: Of the 331 patients, one (0.3%) was negative by the Architect Anti-HBc II assay, in the presence of HBV DNA and positive HBsAg, consistent with recent infection. Positive HBcAb in the absence of HBV DNA was found in 67 of 331 (20.2%) patients. Of these, 18 of 67 had isolated HBcAb with negative results on all other tests, with 12 of 18 (3.6%) demonstrating low HBcAb signals on chemiluminscent microparticle assay. No cases of detectable HBV DNA in the presence of negative serology were found. When the HBcAb was used as a marker for past exposure or chronic HBV infection, the Architect Anti-HBc II assay demonstrated sensitivity and specificity of 98% and 79.9%, respectively, compared to 90% and 78.9%, respectively, for the Elecsys Anti-HBc assay. The combination of the Architect Anti-HBc II and HBsAg assays, as per conventional solid organ donor and recipient screening protocols, had 90% specificity and 100% sensitivity for determining HBV infection. Conclusion: This study shows that the use of combined HBsAg and HBcAb is sensitive and reliable for screening and predicting HBV nucleic acid test (NAT) positivity, whereas HBcAb alone missed an acute infection in this study population. There were no significant differences detectable between the Architect and the Elecsys HBcAb assays ( p=0.001), suggesting laboratories should assess individual assays in the local population before use as screening tests.

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