Anti-HBc Total (IgG/IgM) Reference Testing

Qualitative detection of total antibody, including IgG and IgM, to hepatitis B virus core antigen using electrochemiluminescence immunoassay technology. This test is provided as a specialized reference service for the investigation of reactive, isolated or otherwise discordant total anti-HBc results. It is not intended for routine HBV screening.

Serum or plasma sample. Minimum volume required for serum or plasma – 0.5 mL.

Collect blood in serum separator tubes (SST) or EDTA tubes.

Store samples refrigerated or frozen until shipped for testing. Ship frozen samples on dry ice, and refrigerated samples on wet ice.

Shipping of specimens shall be done by a TDG certified individual in accordance with TDG regulations. For additional information regarding classification of specimens for the purposes of shipping, consult either Part 2 Appendix 3 of the TDG Regulations or section 3.6.2 of the IATA Dangerous Goods Regulations as applicable.

The patient must have previously undergone HBV triple-panel testing, including:
• HBsAg
• anti-HBs
• total anti-HBc

Reference testing is primarily available for specimens with an isolated reactive total anti-HBc result, defined as reactive total anti-HBc with non-reactive HBsAg and anti-HBs, or for other discordant anti-HBc results requiring further investigation.
Results for all three HBV markers must be provided, including the assay manufacturer or platform used and the numerical anti-HBc result, such as the signal-to-cutoff or index value, when available.

Other unusual or complex serological profiles may be accepted following consultation with the Viral Hepatitis and Bloodborne Pathogens Section.

Completed Viral Hepatitis and Bloodborne Pathogens requisition, including the sender’s name, address, and telephone number. Patient name or identifier (referring specimen laboratory number), date of birth, suspected exposure, test(s) requested, type of specimen, and date collected.

Include:

• complete HBV serology results;
• assay manufacturer or testing platform;
• numerical or signal-to-cutoff results, when available;
• relevant clinical history;
• HBV vaccination history;
• previous HBV results;
• immunosuppression status or planned immunosuppressive therapy, when applicable;
• HBV DNA results, when available.

This service is not intended for routine HBV screening. Referral should be limited to reactive, isolated, unusual or discordant anti-HBc results requiring reference investigation.

Testing is performed using the automated Roche Elecsys total anti-HBc electrochemiluminescence immunoassay.

15 calendar days.

1. Schmidt M, Jimenez A, Mühlbacher A, Oota S, Blanco L, Sakuldamrongpanich T, Schennach H. Seifried E. Head-to_head comparison between two screening systems for HBsAg, anti-HBc, anti-HCV and HIV combination immunoassays in an international, multicentre evaluation study. Vox Sang 2015 109:114-121.
2. Public Health Agency of Canada (2013) Primary Care Management of Hepatitis B – Quick Reference. Authors: Andonov, A. Ling, R., Baril, J., Myers, R., Brubacher, C., Osiowy, C., Butler, G., Pritchard, L., Gale-Rowe, M., Verkoeyen, J., Heathcote, J., Yim, C., and Latham-Carmanico, C. http://publications.gc.ca/pub?id=439952&sl=0.