Table. 4.

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.

J Lab Med Qual Assur 2020;42:166~176 https://doi.org/10.15263/jlmqa.2020.42.4.166
© Lab Med Qual Assur