Molecular Detection of Hepatitis B virus Basal Core Promoter Mutants

Molecular detection of Hepatitis B virus basal core promoter mutants by line probe hybridization assay or by sequence analysis.

Serum or plasma sample. Minimum volume required for serum or plasma – 1.0 mL.

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

Store samples frozen until shipped for testing. Ship frozen on dry 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.

Suspected Hepatitis B infection. Serology results must show markers to the Hepatitis B virus and HBV DNA results must be positive.

Completed Molecular and Immuno Diagnostics on Hepatitis requisition including sender name, address and telephone number. Patient name or identifier (referring specimen lab #), date of birth, suspected exposure, test(s) requested. Type of specimen and date collected. If possible, include the clinical history and lab results (particularly HBeAg/eAb test results) that have already been done at local or provincial laboratories.

Conventional PCR followed by line probe hybridization assay. Reactivity to 1762T/1764A probes indicates a basal core promoter mutation. LiPA analysis will be followed up by sequence analysis in cases of probe site negativity.

19 calendar days.

1. Hussain M, Chu C, Sablon E, et al. Rapid and sensitive asays for determination of hepatitis B virus (HBV) genotypes and detection of HBV precore and core promoter variants. J Clin Microbiol 2003 41:3699-3705.
2. Jammeh S, Tavner F, Watson R, et al. Effect of basal core promoter and pre-core mutations on hepatitis B virus replication. J Gen Virol 2008 89:901-909.