TABLE 4.

Commercially available assays and reagents for HBV DNA quantification

Test or reagent (manufacturer)MethodAnalytical sensitivityaLinear rangeaReference(s)Regulatory statusb
IU/mlCopies/mlIU/mlCopies/ml
RealTime HBV PCR (Abbott Molecular)Real-time PCR4*9-4 × 109*Europe, CE; United States, ASR
Hybrid Capture II (Digene)Hybrid capture1.9 × 1051.9 × 105-1.7 × 109107United States, RUO
3.0 × 106-1.0 × 109118
Ultrasensitive Hybrid Capture II (Digene)Hybrid capture8 × 1038.0 × 103-1.7 × 109107United States, RUO
Artus HBV PCR (QIAGEN Diagnostics)Real-time PCR54-3.6 × 10956Europe, CE; United States, not available
2.5 × 102-1.0 × 109135
COBAS Amplicor HBV Monitor (Roche Diagnostics)Semiautomated PCR2 × 1022.0 × 102-2.0 × 10569, 90Europe, CE; United States, RUO
1 × 103-3 × 105118
COBAS TaqMan HBV (Roche Diagnostics)Real-time PCR35†1.7 × 102-8.5 × 108146Europe, CE; United States, ASR, RUO (with HighPure extraction)
12‡54-1.1 × 10851
∼35§30-1.1 × 108§124
∼2.5¶6-2.1 × 10839
VERSANT HBV DNA 3.0 (Siemens Medical Solutions Diagnostics)bDNA3.3 × 1033.3 × 103-1.0 × 108156Europe, CE; United States, RUO
  • a Symbols: *, data from company website (http://www.international.abbott.molecular.com/HBVPCRkit_1137.asp); †, nucleic acid extraction with HighPure (Roche Diagnostics); ‡, extraction with COBAS AmpliPrep and HBV-specific chemistry (Roche Diagnostics); §, extraction with COBAS AmpliPrep and Total Nucleic Acid chemistry (Roche Diagnostics); ¶, extraction with MagNAPure (Roche Diagnostics).

  • b CE, Conformité Européen (approval according to European In Vitro Diagnostic Directive 98/79/EC); ASR, analyte-specific reagent; RUO, research use only.