Laboratory Medicine and Quality Assurance

Table. 4.

Instruments used for hepatitis testing in the first and second trials in 2020, 2021, and 2022

Manufacturer Instrument Method Anti-HAV IgG Anti-HAV IgM Anti-HAV total Anti-HBc IgM Anti-HBc total Anti-HBe HBeAg Anti-HBs HBsAg Anti-HCV
1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
PT in 2020
Abbott Alinity I CLIA 32 42 32 42 ─ ─ 28 38 32 44 44 60 44 60 46 68 46 68 44 62
ARCHITECT CLIA 220 216 174 170 2 4 58 52 94 92 174 166 176 168 430 428 428 424 392 390
Others CLIA - - - - - - - - - - - - - - 2 52 8 60 2 20
Alere Inc. Triage Meter-pro/others ICA - - - - - - - - - - - - - - 8 - 8 - 2 -
Beckman Coulter Access2 CLIA 4 2 4 4 2 2 - - - - - - - - 38 36 38 36 24 24
UniCel DxI800 CLIA 10 8 16 14 12 12 - - - - - - - - 38 40 38 40 38 40
Biomerieux Mini vidas/Vidas/Vidas 3 FEIA 2 - 28 24 24 20 12 16 4 4 10 10 10 14 16 14 20 20 10 10
Boditech AFIAS-6 FEIA - - - - - - - - - - - - - - 2 6 2 4 2 4
DiaSorin ETI-Max 3000/LIAISON/Liaison XL CLIA - - 6 4 6 4 - - - - 2 - 2 - 2 2 2 2 2 2
Fujirebio Inc. Lumipulse G1200 CLIA - - - - - - - - - - - - 2 2 12 14 16 18 - 2
Ortho Clinical Diagnostics ECiQ CLIA - - - - 2 2 - - - - - - 2 2 18 18 18 18 12 12
Vitros3600/5600 CLIA - - 4 4 4 4 - - - - - - - - 8 8 8 8 8 8
Radim Alisei CLIA - - - - - - - - - - - - - - - - - - 2 2
Roche cobas4000 e411 ECLIA 22 20 46 42 56 52 2 2 - - 48 48 54 52 294 268 294 266 188 178
cobas e 601/e 602/e 801 modules, E170 ECLIA 12 10 130 128 182 180 54 50 80 74 156 150 156 154 352 372 358 380 292 302
Siemens Healthineers ADVIA Centaur CP/XP/XPT CLIA 2 0 34 28 50 46 12 10 18 16 30 28 30 28 118 104 120 108 100 90
Atellica IM 1300/1600 CLIA 6 2 28 26 26 30 2 4 10 10 22 26 22 26 48 58 66 76 56 58
Quadriga BeFree System EIA - - - - - - - - - - - - - - - - - - 8 8
Tosoh AIA-360 MEIA - - - - - - - - - - - - - - 2 2 2 2 - -
PT in 2021
Abbott Alinity I CLIA 52 78 54 74 2 - 46 50 54 64 72 92 72 92 80 114 80 114 74 104
ARCHITECT CLIA 222 210 164 146 - - 48 44 92 84 158 142 160 144 422 400 418 396 376 352
Others CLIA - - - - - - - - - - 4 2 4 2 66 74 76 80 24 30
Alere Inc. Others ICA - - - - - - - - - - - - - - 2 - 2 - 2 -
Beckman Coulter Access2 CLIA - - 4 2 4 2 - - - - - - - - 38 32 38 32 26 26
UniCel DxI800 CLIA 6 4 12 16 10 14 - - - - - - - - 40 38 40 38 36 36
Biomerieux Mini vidas/Vidas/Vidas 3 FEIA - - 22 20 20 18 16 16 4 4 6 4 6 4 8 8 14 14 6 6
Boditech AFIAS-6 FEIA - - - - - - - - - - 2 2 2 2 10 10 8 8 6 4
DiaSorin ETI-Max 3000/Liaison XL CLIA - - 4 4 4 4 - - - - - - - - - 2 2 2 2 2
Fujirebio Inc. Lumipulse G1200 CLIA - - - - - - - - - - - - 2 2 12 12 16 16 4 4
Ortho Clinical Diagnostics ECiQ CLIA - - - - 2 2 - - - - - - 2 2 18 18 18 18 12 12
Vitros3600/5600 CLIA - - 4 4 4 4 - - - - - - - - 8 8 8 8 10 8
Roche cobas4000 e411 ECLIA 22 22 40 46 56 54 - - - - 54 56 56 62 290 294 290 296 196 194
cobas e 601/e 602/e 801 modules, others ECLIA 12 12 144 136 168 186 50 50 76 76 160 154 164 156 384 382 394 392 318 326
Siemens Healthineers ADVIA Centaur CP/XP/XPT CLIA - - 28 26 42 34 10 8 14 14 22 20 22 20 100 92 104 94 88 76
Atellica IM 1300/1600 CLIA 4 2 26 26 34 40 4 4 10 10 26 24 26 24 66 68 84 88 64 70
Quadriga BeFree System EIA - - - - - - - - - - - - - - - - - - 8 6
Tosoh AIA-360 MEIA - - - - - - - - - - - - - - 2 2 2 2 - -
PT in 2022
Abbott Alinity I CLIA 102 126 94 118 - 2 52 60 74 92 108 130 106 130 140 176 146 182 130 176
ARCHITECT CLIA 198 176 132 112 - - 40 36 78 62 122 100 126 102 378 342 376 340 326 292
Others CLIA - - - - - - - - - - - - - - 60 54 60 58 26 20
Beckman Coulter Access2 CLIA - - 2 2 4 4 - - - - 2 2 2 2 32 30 32 30 24 20
UniCel DxI800 CLIA 6 8 12 16 10 10 - - - - - - - - 36 34 36 34 34 34
Biomerieux Mini vidas/Vidas FEIA - - 18 18 16 16 14 14 4 4 2 2 2 2 10 8 14 12 6 6
Boditech AFIAS-6 FEIA - - - - - - - - - - - - - - 4 6 4 6 2 2
DiaSorin Liaison XL CLIA - - 2 2 2 2 - - - - - - - - - - - - - -
Fujirebio Inc. Lumipulse G1200 CLIA - - - - - - - - - - 2 2 2 4 12 12 16 16 4 4
Ortho Clinical Diagnostics ECiQ CLIA - - - - - - - - - - - - - 2 20 18 20 18 14 12
Vitros3600/5600 CLIA - - 4 4 4 4 - - - - - - - - 8 12 8 12 8 12
Roche cobas4000 e411/pure e402 ECLIA 18 12 42 38 46 46 - - - - 52 54 58 56 314 306 316 310 196 192
cobas e 601/e 602/e 801 modules ECLIA 12 12 150 152 200 202 52 48 76 72 168 166 170 172 402 416 412 422 346 354
Siemens Healthineers ADVIA Centaur CP/XP/XPT CLIA - 2 22 26 28 28 4 2 6 4 14 12 14 12 72 70 74 72 60 58
Atellica IM 1300/1600 CLIA 2 2 28 28 48 50 8 8 18 18 32 36 32 36 82 86 100 106 80 84
Quadriga BeFree System EIA - - - - - - - - - - - - - - - - - - 6 -
Tosoh AIA-360 MEIA - - - - - - - - - - - - - - 2 2 2 - - -

The following tests were used: Architect (Abbott Diagnostics, Abbott Park, IL, USA), UniCel DxI 800, Access (Beckman Coulter Inc., Brea, CA, USA), Mini vidas/Vidas/Vidas 3 (BioMérieux, Marcy l’Etoile, France), Lumipulse (Fujirebio, Tokyo, Japan), Vitros 3600, 5600, ECiQ (Ortho Clinical Diagnostics, Raritan, NJ, USA), Alisei (Radim, Pomezia, Italy), Cobas e411/pure e402, e 601/e 602/e 801 modules/E170 (Roche Diagnostics GmbH, Mannheim, Germany), Centaur CP/XP/XPT, Atellica IM 1300/1600, Quadriga BeFree (Siemens Healthineers, Erlangen, Germany), AIA-360 (Tosoh, Tokyo, Japan), Liaison/Liaison XL, ETI-Max 3000 (DiaSorin, Saluggia, Italy), 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; PT, proficiency testing; CLIA, chemiluminescence immunoassay; ICA, immunochromatography assay; FEIA, fluorescence EIA; ECLIA, eletro-chemiluminescence immunoassay; EIA, enzyme immunoassay; MEIA, microparticle enzyme immunoassay.
Lab Med Qual Assur 2023;45:135~148 https://doi.org/10.15263/jlmqa.2023.45.4.135
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