Table 1.
Characteristics of assays used for quantitative HBsAg measurement
| Device Trade Name (abbreviation in this study) | Lumipulse HBsAg‐HQ | Architect HBsAg QT | HISCL HBsAg | Lumipulse HBsAg | ADVIA Centaur HBsAg II |
|---|---|---|---|---|---|
| Manufacturer | Fujirebio Inc. | Abbott Japan Co. Ltd. | Sysmex Co. Ltd. | Fujirebio Inc. | Siemens Healthcare Diagnostics Inc. |
| Principle of operation | CLEIA | CLIA | CLEIA | CLEIA | CLIA |
| Unit | IU/mL (quantitative) | IU/mL (quantitative) | IU/mL (quantitative) | COI (qualitative) | COI (qualitative) |
| Capture antibodies | Monoclonal (two) | Monoclonal (two) | Monoclonal (various) | Polyclonal | Monoclonal |
| Conjugate antibodies | Monoclonal (two) | Polyclonal | Monoclonal (various) | Monoclonal (two) | Monoclonal |
| Reaction time (min) | 30 | 30 | 17 | 30 | 30 |
| Sample volume (μL) | 100 | 75 | 20 | 100 | 100 |
| Positive criterion | ≥0.005 IU/mL | ≥0.05 IU/mL | ≥0.03 IU/mL | COI ≥ 1.0 | COI ≥ 1.0 |
| Measuring range (theoretical value range) | 0.005‐150 IU/mL (auto dilution) | 0.05‐250 IU/mL (manual/auto dilution) | 0.03‐2500 IU/mL (auto dilution) | 0.1‐2000 COI | 0.1‐1000 Index |
CLEIA, Chemiluminescent Enzyme Immuno Assay; CLIA, Chemiluminescent Immuno Assay.