TABLE 4.
Assay-specific diagnostic performancea
| Assay | True positive (n) | False negative (n) | True negative (n) | False positive (n) | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|---|---|
| IgG | ||||||
| Abbott | 145 | 1 | 102 | 0 | 99.32 (96.24–99.98) | 100 (96.45–100) |
| Euroimmun | 431 | 7 | 319 | 3 | 98.40 (96.73–99.36) | 99.07 (97.30–99.81) |
| Ortho Clinical Diagnostic/Johnson & Johnson | 3 | 0 | 1 | 0 | 100 (29.24–100) | 100 (2.50–100) |
| Becton Dickinson | 2 | 0 | 2 | 0 | 100 (15.81–100) | 100 (15.81–100) |
| Beckmann Coulter | 9 | 0 | 7 | 0 | 100 (66.37–100) | 100 (59.04–100) |
| BioMerieux | 5 | 0 | 3 | 0 | 100 (47.82–100) | 100 (29.24–100) |
| Eppendorf | 1 | 1 | 2 | 0 | 50.0 (1.26–98.47) | 100 (15.81–100) |
| Siemens Healthineers | 3 | 0 | 1 | 0 | 100 (29.24–100) | 100 (2.50–100) |
| Roche | 459 | 7 | 312 | 2 | 98.5 (96.93–99.39) | 99.36 (97.72–99.92) |
| DRG | 6 | 0 | 6 | 0 | 100 (54.07–100) | 100 (54.07–100) |
| Siemens Healthineers (Advia) | 42 | 0 | 22 | 0 | 100 (91.59–100) | 100 (84.56–100) |
| Mediagnost | 5 | 0 | 3 | 0 | 100 (47.82–100) | 100 (29.24–100) |
| Immundiagnostik | 7 | 3 | 9 | 1 | 70.0 (34.75–93.33) | 90.0 (55.50–99.75) |
| Medipan Diagnostika | 4 | 0 | 4 | 0 | 100 (39.76–100) | 100 (39.76–100) |
| DiaSorin | 241 | 20 | 183 | 4 | 92.34 (88.41–95.26) | 97.86 (94.61–99.41) |
| Epitope Diagnostics | 40 | 11 | 41 | 0 | 78.43 (64.68–88.71) | 100 (91.4–100) |
| Virotech Diagnostics | 20 | 4 | 20 | 0 | 83.33 (62.62–95.26) | 100 (83.16–100) |
| Other | 134 | 18 | 100 | 4 | 88.16 (81.93–92.83) | 96.15 (90.44–98.94) |
| MöLab | 5 | 1 | 5 | 1 | 83.33 (35.88–99.58) | 83.33 (35.88–99.58) |
| GA (Generic Assay) | 12 | 0 | 8 | 0 | 100 (73.54–100) | 100 (63.06–100) |
| AESKU.Diagnostics | 6 | 0 | 2 | 0 | 100 (54.07–100) | 100 (15.81–100) |
| R-Biopharm | 5 | 0 | 3 | 0 | 100 (47.82–100) | 100 (29.24–100) |
| nal von minden GmbH | 15 | 3 | 14 | 0 | 83.33 (58.58–96.42) | 100 (76.84–100) |
| Microgen | 26 | 0 | 18 | 0 | 100 (86.77–100) | 100 (81.47–100) |
| Novatech | 5 | 3 | 8 | 0 | 62.5 (24.49–91.48) | 100 (63.06–100) |
| Viramed Biotech | 11 | 0 | 9 | 0 | 100 (71.51–100) | 100 (66.37–100) |
| Willi Fox | 6 | 1 | 5 | 0 | 85.71 (42.13–99.64) | 100 (47.82–100) |
| SchBo | 2 | 0 | 2 | 0 | 100 (15.81–100) | 100 (15.81–100) |
| Bühlmann | 5 | 0 | 3 | 0 | 100 (47.82–100) | 100 (29.24–100) |
| Siemens Healthineers (Vista) | 3 | 0 | 1 | 0 | 100 (29.24–100) | 100 (2.50–100) |
| Virion/Serion | 6 | 0 | 2 | 0 | 100 (54.07–100) | 100 (15.81–100) |
| Advanced Instruments | 2 | 2 | 4 | 0 | 50.0 (6.76–93.24) | 100 (39.76–100) |
| Vircell | 13 | 0 | 7 | 0 | 100 (75.29–100) | 100 (59.04–100) |
| EQA 2/20 | 439 | 57 | 486 | 10 | 88.51 (85.37–91.18) | 97.98 (96.32–99.03) |
| EQA 3/20 | 483 | 5 | 485 | 3 | 98.98 (97.63–99.67) | 99.39 (98.21–99.87) |
| EQA 4/20 | 757 | 20 | 257 | 2 | 97.43 (96.05–98.42) | 99.23 (97.24–99.91) |
| Total | 1,679 | 82 | 1,228 | 15 | 95.34 (94.25–96.28) | 98.79 (98.02–99.32) |
| IgA | ||||||
| Abbott | 3 | 3 | 2 | 0 | 50.0 (11.81–88.19) | 100 (15.81–100) |
| Euroimmun | 166 | 3 | 152 | 27 | 98.22 (94.90–99.63) | 84.92 (78.82–89.82) |
| Becton Dickinson | 0 | 1 | 3 | 0 | 0 (0.00–97.50) | 100 (29.24–100) |
| BioMerieux | 2 | 1 | 1 | 0 | 66.67 (9.43–99.16) | 100 (2.50–100) |
| DRG | 0 | 1 | 3 | 0 | 0 (0.00–97.50) | 100 (29.24–100) |
| Mediagnost | 4 | 0 | 4 | 0 | 100 (39.76–100) | 100 (39.76–100) |
| Virotech Diagnostics | 0 | 9 | 11 | 0 | 0 (0.00–33.63) | 100 (71.51–100) |
| Other | 4 | 15 | 9 | 0 | 21.05 (6.05–45.57) | 100 (66.37–100) |
| AESKU.Diagnostics | 0 | 3 | 1 | 0 | 0 (0.00–60.76) | 100 (2.50–100) |
| R-Biopharm | 0 | 4 | 4 | 0 | 0 (0.00–60.24) | 100 (39.76–100) |
| nal von minden GmbH | 2 | 1 | 1 | 0 | 66.67 (9.43–99.16) | 100 (2.50–100) |
| Microgen | 0 | 4 | 4 | 0 | 0 (0.00–60.24) | 100 (39.76–100) |
| Novatech | 0 | 5 | 7 | 0 | 0 (0.00–52.18) | 100 (59.04–100) |
| Viramed Biotech | 0 | 6 | 9 | 1 | 0 (0.00–45.93) | 90.00 (55.50–99.75) |
| Vircell | 4 | 6 | 5 | 1 | 40.0 (12.16–73.76) | 83.33 (35.88–99.58) |
| EQA 2/20 | ND | ND | ND | ND | ND | ND |
| EQA 3/20 | 49 | 12 | 155 | 28 | 80.33 (68.16–89.40) | 84.70 (78.65–89.59) |
| EQA 4/20 | 136 | 50 | 61 | 1 | 73.12 (66.14–79.34) | 98.39 (91.34–99.96) |
| Total | 185 | 62 | 216 | 29 | 74.90 (69.01–80.18) | 88.16 (83.44–91.93) |
| IgM | ||||||
| Epitope Diagnostics | 0 | 0 | 68 | 0 | NA | 100 (94.72–100) |
| nal von minden GmbH | 0 | 0 | 10 | 2 | NA | 83.33 (51.59–97.91) |
| Advanced Instruments | 0 | 0 | 8 | 0 | NA | 100 (63.06–100) |
| Other | 0 | 0 | 70 | 26 | NA | 72.92 (62.89–81.48) |
| Immundiagnostik | 0 | 0 | 12 | 0 | NA | 100 (73.54–100) |
| Virotech Diagnostics | 0 | 0 | 15 | 1 | NA | 93.75 (69.77–99.84) |
| Euroimmun | 0 | 0 | 3 | 1 | NA | 75.0 (19.41–99.37) |
| Novatech | 0 | 0 | 12 | 0 | NA | 100 (73.54–100) |
| GA-Generic Assay | 0 | 0 | 4 | 0 | NA | 100 (39.76–100) |
| MöLab | 0 | 0 | 6 | 2 | NA | 75.0 (34.91–96.81) |
| Viramed Biotech | 0 | 0 | 4 | 0 | NA | 100 (39.76–100) |
| Willi Fox | 0 | 0 | 2 | 2 | NA | 50.0 (6.76–93.24) |
| EQA 2/20 | 0 | 0 | 214 | 34 | NA | 86.29 (81.37–90.32) |
| EQA 3/20 | ND | ND | ND | ND | ND | ND |
| EQA 4/20 | ND | ND | ND | ND | ND | ND |
| Total | 0 | 0 | 214 | 34 | NA | 86.29 (81.37–90.32) |
a
EQA, external quality assessment.