Principles of methods used for hepatitis testing in the participating laboratories in the first and second trials in 2020, 2021, and 2022
| Test items | Category | CLIA | ECLIA | EIA | FEIA | ICA | MEIA |
|---|---|---|---|---|---|---|---|
| PT in 2020 | |||||||
| Anti-HAV IgG | 2020-1st | 137 (84.0) | 17 (10.4) | - | 1 (0.6) | 7 (4.3) | - |
| 2020-2nd | 135 (85.4) | 15 (9.5) | - | - | 6 (3.8) | - | |
| Anti-HAV IgM | 2020-1st | 149 (58.4) | 88 (34.5) | - | 14 (5.5) | 4 (1.6) | - |
| 2020-2nd | 146 (59.3) | 85 (34.6) | - | 12 (4.9) | 3 (1.2) | - | |
| Anti-HAV total | 2020-1st | 52 (28.3) | 119 (64.7) | - | 12 (6.5) | - | - |
| 2020-2nd | 52 (29.1) | 116 (64.8) | - | 10 (5.6) | - | - | |
| Anti-HBc IgM | 2020-1st | 50 (59.5) | 28 (33.3) | - | 6 (7.1) | - | - |
| 2020-2nd | 52 (60.5) | 26 (30.2) | - | 8 (9.3) | - | - | |
| Anti-HBc total | 2020-1st | 77 (64.7) | 40 (33.6) | - | 2 (1.7) | - | - |
| 2020-2nd | 81 (67.5) | 37 (30.8) | - | 2 (1.7) | - | - | |
| Anti-HBe | 2020-1st | 136 (55.5) | 102 (41.6) | - | 5 (2.0) | 2 (0.8) | - |
| 2020-2nd | 140 (56.9) | 99 (40.2) | - | 5 (2.0) | 2 (0.8) | - | |
| HBeAg | 2020-1st | 139 (53.7) | 105 (40.5) | - | 5 (1.9) | 10 (3.9) | - |
| 2020-2nd | 143 (55.2) | 103 (39.8) | - | 7 (2.7) | 6 (2.3) | - | |
| Anti-HBs | 2020-1st | 380 (36.0) | 323 (30.6) | - | 9 (0.9) | 309 (29.3) | 1 (0.1) |
| 2020-2nd | 414 (39.3) | 320 (30.4) | - | 10 (0.9) | 285 (27.0) | 1 (0.1) | |
| HBsAg | 2020-1st | 394 (36.5) | 326 (30.2) | - | 11 (1.0) | 312 (28.9) | 1 (0.1) |
| 2020-2nd | 429 (39.9) | 323 (30.0) | - | 12 (1.1) | 287 (26.7) | 1 (0.1) | |
| Anti-HCV | 2020-1st | 340 (40.3) | 240 (28.5) | 4 (0.5) | 6 (0.7) | 235 (27.9) | - |
| 2020-2nd | 355 (42.4) | 240 (28.6) | 4 (0.5) | 7 (0.8) | 216 (25.8) | - | |
| PT in 2021 | |||||||
| Anti-HAV IgG | 2021-1st | 142 (86.1) | 17 (10.3) | - | - | 5 (3.0) | - |
| 2021-2nd | 147 (85.5) | 17 (9.9) | - | - | 6 (3.5) | - | |
| Anti-HAV IgM | 2021-1st | 148 (58.3) | 92 (36.2) | - | 11 (4.3) | 3 (1.2) | - |
| 2021-2nd | 149 (58.9) | 91 (36.0) | - | 10 (4.0) | 3 (1.2) | - | |
| Anti-HAV total | 2021-1st | 51 (29.5) | 112 (64.7) | - | 10 (5.8) | - | - |
| 2021-2nd | 50 (27.8) | 120 (66.7) | - | 9 (5.0) | 1 (0.6) | - | |
| Anti-HBc IgM | 2021-1st | 54 (62.1) | 25 (28.7) | - | 8 (9.2) | - | - |
| 2021-2nd | 53 (61.6) | 25 (29.1) | - | 8 (9.3) | - | - | |
| Anti-HBc total | 2021-1st | 85 (68.0) | 38 (30.4) | - | 2 (1.6) | - | - |
| 2021-2nd | 86 (68.3) | 38 (30.2) | - | 2 (1.6) | - | - | |
| Anti-HBe | 2021-1st | 141 (55.5) | 107 (42.1) | - | 4 (1.6) | 2 (0.8) | - |
| 2021-2nd | 140 (56.0) | 105 (42.0) | - | 3 (1.2) | 2 (0.8) | - | |
| HBeAg | 2021-1st | 144 (53.9) | 110 (41.2) | - | 4 (1.5) | 9 (3.4) | - |
| 2021-2nd | 143 (54.0) | 109 (41.1) | - | 3 (1.1) | 10 (3.8) | - | |
| Anti-HBs | 2021-1st | 426 (39.4) | 337 (31.1) | - | 9 (0.8) | 294 (27.2) | 1 (0.1) |
| 2021-2nd | 429 (39.5) | 338 (31.2) | - | 9 (0.8) | 298 (27.5) | 1 (0.1) | |
| HBsAg | 2021-1st | 442 (40.0) | 342 (30.9) | - | 11 (1.0) | 296 (26.8) | 1 (0.1) |
| 2021-2nd | 443 (39.9) | 344 (31.0) | - | 11 (1.0) | 300 (27.0) | 1 (0.1) | |
| Anti-HCV | 2021-1st | 358 (41.7) | 257 (29.9) | 4 (0.5) | 6 (0.7) | 227 (26.4) | - |
| 2021-2nd | 360 (42.0) | 260 (30.3) | 3 (0.4) | 5 (0.6) | 222 (25.9) | - | |
| PT in 2022 | - | ||||||
| Anti-HAV IgG | 2022-1st | 154 (87.0) | 15 (8.5) | - | - | 4 (2.3) | - |
| 2022-2nd | 157 (89.2) | 12 (6.8) | - | - | 5 (2.8) | - | |
| Anti-HAV IgM | 2022-1st | 148 (57.8) | 96 (37.5) | - | 9 (3.5) | 3 (1.2) | - |
| 2022-2nd | 154 (59.0) | 95 (36.4) | - | 9 (3.4) | 3 (1.1) | - | |
| Anti-HAV total | 2022-1st | 48 (26.7) | 123 (68.3) | - | 8 (4.4) | 1 (0.6) | - |
| 2022-2nd | 50 (27.3) | 124 (67.8) | - | 8 (4.4) | 1 (0.5) | - | |
| Anti-HBc IgM | 2022-1st | 52 (61.2) | 26 (30.6) | - | 7 (8.2) | - | - |
| 2022-2nd | 53 (63.1) | 24 (28.6) | - | 7 (8.3) | - | - | |
| Anti-HBc total | 2022-1st | 88 (68.8) | 38 (29.7) | - | 2 (1.6) | - | - |
| 2022-2nd | 88 (69.8) | 36 (28.6) | - | 2 (1.6) | - | - | |
| Anti-HBe | 2022-1st | 140 (55.6) | 110 (43.7) | - | 1 (0.4) | 1 (0.4) | - |
| 2022-2nd | 141 (55.5) | 110 (43.3) | - | 1 (0.4) | 2 (0.8) | - | |
| HBeAg | 2022-1st | 142 (53.2) | 114 (42.7) | - | 1 (0.4) | 9 (3.4) | - |
| 2022-2nd | 144 (53.5) | 114 (42.4) | - | 1 (0.4) | 10 (3.7) | - | |
| Anti-HBs | 2022-1st | 420 (38.1) | 358 (32.5) | - | 7 (0.6) | 302 (27.4) | 1 (0.1) |
| 2022-2nd | 417 (37.8) | 361 (32.8) | - | 7 (0.6) | 304 (27.6) | 1 (0.1) | |
| HBsAg | 2022-1st | 434 (38.5) | 364 (32.3) | - | 9 (0.8) | 305 (27.1) | 1 (0.1) |
| 2022-2nd | 434 (38.5) | 366 (32.4) | - | 9 (0.8) | 308 (27.3) | - | |
| Anti-HCV | 2022-1st | 353 (40.6) | 271 (31.1) | 3 (0.3) | 4 (0.5) | 232 (26.7) | - |
| 2022-2nd | 356 (40.8) | 273 (31.3) | - | 4 (0.5) | 231 (26.5) | - |
Values are presented as number of laboratories (%).
Abbreviations: CLIA, chemiluminescence immunoassay; ECLIA, electrochemiluminescence immunoassay; EIA, enzyme immunoassay; FEIA, fluorescence EIA; ICA, immunochromatography assay; MEIA, microparticle EIA; PT, proficiency testing; 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.