Summary of instruments and methods used to measure viral antigens or antibodies in the second proficiency testing trial: proficiency testing for hepatitis serology analyses in 2018
| Manufacturer | Method | Instrument | Anti-HAV IgG | Anti-HAV IgM | Anti-HAV total | Anti-HBc IgM | Anti-HBc total | Anti-Hbe | HBeAg | Anti-HBs | HBsAg | Anti-HCV |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | CLIA | ARCHITECT | 126 | 96 | 2 | 40 | 67 | 110 | 110 | 247 | 251 | 228 |
| Alinity i | - | - | - | - | - | - | - | - | - | - | ||
| Beckman Coulter | CLIA | Access2 | 1 | 2 | 1 | - | - | - | - | 16 | 16 | 9 |
| UniCel DxI800 | 6 | 10 | 8 | - | - | - | - | 19 | 19 | 18 | ||
| Biokit | EIA | BEST 2000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 |
| Biomerieux | FEIA | Mini vidas/Vidas | 1 | 17 | 14 | 8 | 2 | 9 | 9 | 15 | 24 | 10 |
| Bio-Rad | EIA | Evolis | - | - | - | - | - | - | - | - | - | 1 |
| DiaSorin | CLIA | ETI-Max 3000/LIAISON | 1 | 3 | 4 | - | - | 1 | 1 | 1 | 1 | 2 |
| Fujirebio Inc. | CLIA | Lumipulse G1200 | - | - | - | - | - | - | - | 4 | 5 | - |
| Ortho Clinical Diagnostics | CLIA | Eci/EciQ | - | 1 | 2 | 0 | 0 | 0 | 1 | 7 | 7 | 7 |
| Vitros3600/5600 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 5 | 5 | 5 | ||
| Radim | CLIA | Alisei | - | - | - | - | - | - | - | - | - | 1 |
| Roche | ECLIA | Cobas e 411 | 13 | 18 | 22 | 2 | 2 | 24 | 27 | 152 | 153 | 91 |
| Cobas e601/e602/e801 modules, E170 | 2 | 54 | 73 | 25 | 38 | 68 | 70 | 150 | 161 | 117 | ||
| Siemens Healthcare | CLIA | ADVIA Centaur CP/XP/XPT, IMMULITE 2000 | 1 | 32 | 38 | 9 | 12 | 26 | 26 | 84 | 86 | 76 |
| Atellica IM 1300/1600 | - | - | - | - | - | - | - | - | - | - | ||
| Quadriga BeFree System | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | ||
| Tosoh | MEIA | AIA-360 | - | - | - | - | - | - | - | 1 | 1 | - |
| Boditech Med Inc. | FEIA | AFIAS-6 | - | - | - | - | - | - | - | - | - | - |
| Alere Inc. | ICA | Triage Meter-pro/others | - | - | - | - | - | - | - | 4 | 3 | - |
| Others | 2 | - | - | - | - | - | - | 24 | 24 | 9 | ||
| Total | 154 | 234 | 165 | 84 | 121 | 238 | 244 | 730 | 757 | 580 |
Values are presented as number of laboratories. The following test was used: Architect (Abbott Diagnostics, Abbott Park, IL, USA), UniCel DxI 800, Access (Beckman Coulter Inc., Brea, CA, USA), BEST 2000 (Biokit, Barcelona, Spain), Mini vidas/Vidas (BioMérieux, Marcy l’Etoile, France), Lumipulse (Fujirebio, Tokyo, Japan), Vitros 3600, 5600, ECi, ECiQ (Ortho Clinical Diagnostics, Raritan, NJ, USA), Alisei (Radim, Pomezia, Italy), Cobas e411, e601/e602/e801 modules/E170 (Roche Diagnostics GmbH, Mannheim, Germany), Centaur CP/XP/XPT, Immulite 2000, Atellica IM 1300/1600, Quadriga BeFree (Siemens Healthineers, Erlangen, Germany), AIA-360 (Tosoh, Tokyo, Japan), Liaison, ETI-Max 3000 (DiaSorin, Saluggia, Italy), Evolis (Bio-Rad Laboratories, Hercules, CA, USA), AFIAS-6 (Boditech Med Inc., Chuncheon, Korea), and Triage Meter-pro (Alere Inc., San Diego, CA, USA).
Abbreviations: anti-HAV, antibody to hepatitis A virus; IgG, immunoglobulin G; IgM, immunoglobulin M; anti-HBc, antibody to hepatitis B core antigen; anti-HBe, antibody to HBeAg; HBeAg, hepatitis B envelope antigen; anti-HBs, antibody to HBsAg; HBsAg, hepatitis B surface antigen; anti-HCV, antibody to hepatitis C virus; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence EIA; ECLIA, electrochemiluminescence immunoassay; MEIA, microparticle EIA; ICA, immunochromatography assay.