TABLE 1.
Characteristics of automated and microtiter HBsAg screening assays
| Screening type and test | Manufacturer | Test principlea | Capture antibody | Conjugate | Sample vol (μl) | Incubation time (min) | Cutoff calculation | Interpretation (signal/cutoff)
|
|
|---|---|---|---|---|---|---|---|---|---|
| Positive result | Negative result | ||||||||
| Automated | |||||||||
| IMMULITE, HBsAg | DPC | Sandwich CEIA | MAbb (mouse) | Polyclonal (goat) | 100 | 70 | By calibration | ≥1 | <1 |
| IMMULITE, 2000 HBsAg | DPC | Sandwich CEIA | MAb (mouse) | Polyclonal (goat) | 100 | 70 | By calibration | ≥1 | <1 |
| Elecsys HBsAg | Roche | Sandwich CEIA | MAb (mouse) | MAb (mouse) | 50 | 18 | By calibration | ≥1 | <1 |
| AxSYM HBsAg | Abbott | Sandwich ELFA | MAb (mouse) | MAb (mouse) | ≥1 | <1 | |||
| Prism HBsAg | Abbott | Sandwich CEIA | MAb IgM (mouse) | Polyclonal (goat) | 400 | Mean NCC + 0.2 × mean PCCc | ≥1 | <1 | |
| VIDAS HBsAg | Biomérieux | Sandwich ELFA | MAb (mouse) | MAb (mouse) | 150 | 90 | By calibration | ≥0.1 | <0.1 |
| Microtiter | |||||||||
| Enzygnost HBsAg 5.0 | Dade-Behring | Sandwich EIA | MAb (mouse) | Polyclonal (goat) | 100 | 105 | By calibration | ≥1 | <1 |
| HBsAg (version 3) | Murex | Sandwich EIA | MAb (mouse) | Polyclonal (goat) | 100 | 105 | By calibration | ≥1 | <1 |
a
Abbreviations: CEIA, chemiluminescent enzyme immunoassay; ELFA, enzyme-linked fluorescent assay; EIA, enzyme immunoassay.
b
MAb, monoclonal antibody.
c
Abbreviations: NCC, negative control counts; PCC, positive control counts.