Table. 5.

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 2019

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 116 90 3 34 53 90 90 224 226 202
Alinity I 11 10 - 9 12 16 16 16 16 16
Beckman Coulter CLIA Access2 1 2 1 - - - - 21 21 12
UniCel DxI800 5 9 8 - - - - 20 20 20
Biokit EIA BEST 2000 0 0 0 0 0 0 0 1 1 2
Biomerieux FEIA Mini vidas/Vidas 1 16 14 7 2 6 6 8 11 7
Bio-Rad EIA Evolis - - - - - - - - - 1
DiaSorin CLIA ETI-Max 3000/LIAISON 1 3 3 - - 1 1 2 2 1
Fujirebio Inc. CLIA Lumipulse G1200 - - - - - - - 5 6 -
Ortho Clinical Diagnostics CLIA Eci/EciQ 0 0 1 0 0 0 1 7 7 6
Vitros3600/5600 0 1 1 0 0 0 0 4 4 4
Radim CLIA Alisei - - - - - - - - - 1
Roche ECLIA Cobas e411 11 16 21 1 1 28 29 155 155 92
Cobas e601/e602/e801 modules, E170 4 59 78 26 38 72 75 170 176 137
Siemens Healthcare CLIA ADVIA Centaur CP/XP/XPT, IMMULITE 2000 1 20 25 5 8 17 17 62 64 52
Atellica IM 1300/1600 1 10 9 1 4 8 8 16 20 22
Quadriga BeFree System - - - - - - - - - 4
Tosoh MEIA AIA-360 - - - - - - - 2 2 -
Boditech Med Inc. FEIA AFIAS-6 - - - - - - - 1 1 -
Alere Inc. ICA Triage Meter-pro - - - - - - - 3 3 2
Others 1 - - - 1 - - 23 26 15
Total 153 236 164 83 119 238 243 740 761 596

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: HBsAg, hepatitis B surface antigen; anti-HBs, antibody to HBsAg; anti-HBc, antibody to hepatitis B core antigen; HBeAg, hepatitis B envelope antigen; anti-HBe, antibody to HBeAg; anti-HCV, antibody to hepatitis C virus; anti-HAV, antibody to hepatitis A virus; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; ECLIA, electrochemiluminescence immunoassay; FEIA, fluorescence EIA; MEIA, microparticle enzyme immunoassay.

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