Table 3. Sigma metrics for the proficiency testing (PT)-based approach.
| Item | Sample number | Mean | CV (%) | Bias (%) | σCLIA | σWS/T | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
||
| Alb | 201721 | 46 | 49 | 51 | 1.0 | 1.4 | 0.8 | - 1.2 | - 1.0 | 5.8 | 8.4 | 6.6 | 5.2 | 4.6 | 3.7 | 0.3† |
| 201722 | 24 | 26 | 26 | 1.2 | 3.0 | 0.8 | - 2.2 | 0.5 | 2.6 | 6.4 | 3.2 | 9.5 | 3.1 | 1.9† | 4.4 | |
| 201723 | 32 | 35 | 35 | 1.0 | 2.1 | 1.3 | - 1.8 | - 0.4 | 3.6 | 8.5 | 4.5 | 4.8 | 4.4 | 2.6† | 1.8† | |
| 201724 | 46 | 49 | 52 | 2.3 | 1.6 | 1.1 | - 1.1 | - 1.5 | 7.2 | 3.8 | 5.5 | 2.6† | 2.1† | 2.9† | - 1.1† | |
| 201725 | 37 | 40 | 41 | 1.3 | 2.1 | 0.8 | - 2.9 | - 2.2 | 2.9 | 5.5 | 3.8 | 9.4 | 2.4† | 1.9† | 4.1 | |
| ALT | 201721 | 160 | 153 | 164 | 0.6 | 1.0 | 0.9 | - 2.8 | - 2.3 | - 1.3 | 27.7 | 18.3 | 21.5 | 21.3 | 14.2 | 16.9 |
| 201722 | 31 | 29 | 32 | 3.0 | 4.0 | 4.6 | - 2.8 | - 1.1 | 0.7 | 5.8 | 4.7 | 4.2 | 4.5 | 3.7 | 3.3 | |
| 201723 | 77 | 74 | 81 | 0.8 | 2.7 | 2.4 | - 3.4 | - 3.3 | 0.1 | 19.8 | 6.2 | 8.2 | 15 | 4.7 | 6.6 | |
| 201724 | 144 | 137 | 149 | 0.8 | 1.3 | 2.0 | - 2.5 | - 2.6 | 0.5 | 21.1 | 13.1 | 9.6 | 16.2 | 10.1 | 7.7 | |
| 201725 | 100 | 97 | 105 | 1.2 | 1.7 | 1.8 | - 4.7 | - 3.4 | - 2.6 | 13 | 10 | 9.7 | 9.6 | 7.6 | 7.5 | |
| BT | 201721 | 128.1 | 121.1 | 129.4 | 1.1 | 0.8 | 0.7 | - 6.3 | - 4.0 | - 6.8 | 13 | 19.6 | 18.6 | 8.3 | 13.5 | 11.5 |
| 201722 | 12.5 | 11.3 | 13.8 | 1.3 | 1.8 | 2.2 | - 7.1 | - 8.5 | 1.7 | 36.8* | 27.6* | 22.0* | 6.3 | 3.6 | 6.1 | |
| 201723 | 25.4 | 23.5 | 27.8 | 0.9 | 1.4 | 1.3 | - 14.6 | - 7.4 | 0.1 | 11.3 | 15 | 18.9 | 0.4† | 5.5 | 11.7 | |
| 201724 | 85.9 | 82.0 | 89.1 | 1.0 | 1.9 | 0.6 | - 4.2 | - 4.9 | - 5.9 | 16 | 7.8 | 22.7 | 11 | 5.2 | 14.7 | |
| 201725 | 38.16 | 35.9 | 41.0 | 1.3 | 1.2 | 1.3 | - 12.9 | - 7.8 | - 4.0 | 5.6 | 10.4 | 12.3 | 1.7† | 6.2 | 8.4 | |
| Item | Sample number | Mean | CV (%) | Bias (%) | σCLIA | σWS/T | ||||||||||
|
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
Beckman AU5800 |
Roche C8000 |
Siemens Dimension |
||
| Glc | 201721 | 13.4 | 13.3 | 14.2 | 1.2 | 1.4 | 1.6 | - 2.7 | - 2.1 | 3.5 | 6.1 | 5.6 | 4.1 | 3.6 | 3.5 | 2.2† |
| 201722 | 3.8 | 3.7 | 4.0 | 1.1 | 1.1 | 2.2 | - 3.0 | - 2.9 | 5.5 | 6.6 | 6.7 | 2† | 3.8 | 3.9 | 0.7† | |
| 201723 | 6.6 | 6.6 | 7.1 | 1.4 | 1.1 | 2.4 | - 3.1 | - 2.8 | 4.5 | 5 | 6.9 | 2.3† | 2.8† | 4 | 1.1† | |
| 201724 | 10.8 | 10.8 | 11.5 | 1.3 | 1.2 | 1.8 | - 2.8 | - 2.6 | 4.3 | 5.4 | 6.2 | 3.2 | 3.2 | 3.7 | 1.5† | |
| 201725 | 7.3 | 7.2 | 7.8 | 1.4 | 0.9 | 1.4 | - 4.5 | - 4.5 | 2.4 | 3.8 | 6.5 | 5.3 | 1.7† | 3 | 3.2 | |
| CREA | 201721 | 466 | 464 | 452 | 0.8 | 1.2 | 0.7 | - 0.2 | 2.1 | 0.4 | 19.4 | 11 | 21 | 15.5 | 8.4 | 16.7 |
| 201722 | 85 | 88 | 82 | 0.8 | 1.2 | 2.1 | 9.6 | 5.4 | 0.8 | 28.8* | 20.2* | 14.9* | 3.1 | 5.3 | 5.3 | |
| 201723 | 223 | 225 | 218 | 0.6 | 1.2 | 2.9 | 2.9 | 1.8 | 1.5 | 19.3 | 11.3 | 4.7 | 14.5 | 8.7 | 3.7 | |
| 201724 | 469 | 467 | 455 | 0.8 | 1.1 | 1.2 | - 0.7 | 1.4 | - 0.7 | 17.4 | 12.2 | 11.9 | 13.7 | 9.5 | 9.4 | |
| 201725 | 289 | 289 | 284 | 0.7 | 1.0 | 1.0 | - 0.2 | - 0.2 | - 0.1 | 21.2 | 14.8 | 14.9 | 16.9 | 11.8 | 11.9 | |
| Urea | 201721 | 17.41 | 17.58 | 18.17 | 2.0 | 3.6 | 1.3 | - 3.9 | - 2.6 | 0.2 | 2.6† | 1.8† | 7.1 | 2.1† | 1.5† | 6.3 |
| 201722 | 4.05 | 4.21 | 4.25 | 2.0 | 3.1 | 3.0 | - 7.0 | - 1.8 | - 1.0 | 8.8* | 7.1* | 7.7* | 0.5† | 2† | 2.4† | |
| 201723 | 9.31 | 9.49 | 9.77 | 2.2 | 3.0 | 1.4 | - 5.1 | - 2.4 | - 0.4 | 2.5*† | 2.6*† | 6.9* | 1.3† | 1.8† | 5.5 | |
| 201724 | 15.39 | 15.62 | 16.12 | 1.7 | 3.6 | 1.8 | - 4.0 | - 2.5 | - 0.6 | 3 | 1.8† | 4.8 | 2.4† | 1.5† | 4.3 | |
| 201725 | 11.11 | 11.28 | 11.76 | 2.4 | 3.3 | 1.9 | - 6.1 | - 4.2 | - 0.9 | 1.2† | 1.5† | 4.2 | 0.8† | 1.2† | 3.7 | |
| K | 201721 | 6.3 | 6.4 | 6.3 | 1.2 | 0.6 | 0.8 | 0.6 | 0.6 | 0.4 | 6.4* | 12.8* | 9.2* | 4.7 | 9.6 | 6.9 |
| 201722 | 2.7 | 2.8 | 2.7 | 1.0 | 1.2 | 0.9 | - 2.3 | - 0.5 | - 2.3 | 16.6* | 14.7* | 17.3* | 3.8 | 4.7 | 4 | |
| 201723 | 4.3 | 4.4 | 4.3 | 0.5 | 0.6 | 0.8 | 0.4 | 0.1 | 0.5 | 21.8* | 20.0* | 14.4* | 10.9 | 10.5 | 7.2 | |
| 201724 | 6.0 | 6.0 | 6.0 | 0.5 | 0.5 | 0.9 | 1.0 | 0.7 | 0.6 | 14.5* | 17.0* | 8.6* | 9.8 | 12 | 5.9 | |
| 201725 | 4.7 | 4.8 | 4.7 | 0.7 | 0.3 | 1.1 | - 1.0 | - 1.1 | - 1.2 | 14.1* | 31.1* | 8.7* | 7.3 | 16.4 | 4.4 | |
| Na | 201721 | 157 | 159 | 155 | 0.8 | 0.6 | 0.7 | 0.1 | 0.4 | - 1.4 | 3.2* | 3.6* | 1.8*† | 5.1 | 6.1 | 3.9 |
| 201722 | 108 | 111 | 112 | 0.8 | 0.9 | 0.8 | - 2.5 | 0.3 | 1.0 | 1.4*† | 3.6* | 3.3* | 1.8† | 4 | 3.9 | |
| 201723 | 128 | 130 | 129 | 0.4 | 0.8 | 0.8 | - 0.8 | 0.5 | 0.3 | 5.2* | 3.4* | 3.5* | 7.1 | 4.5 | 4.6 | |
| 201724 | 153 | 154 | 153 | 0.5 | 0.5 | 1.1 | 0.3 | 2.2 | 0.5 | 5.0* | 0.9*† | 2.0*† | 8.1 | 3.8 | 3.3 | |
| 201725 | 133 | 135 | 135 | 0.5 | 0.5 | 1.2 | - 2.1 | - 0.7 | - 1.0 | 1.5† | 5.1 | 1.7† | 3.5 | 7.4 | 2.7† | |
| Cl | 201721 | 108 | 107 | 105 | 0.8 | 0.7 | 0.9 | 0.7 | 1.7 | - 2.6 | 5.3 | 5 | 2.7† | 4.1 | 3.5 | 1.6† |
| 201722 | 76 | 72 | 72 | 0.6 | 0.8 | 1.2 | 0.9 | 3.9 | - 1.4 | 7.2 | 1.4† | 3 | 5.5 | 0.1† | 2.1† | |
| 201723 | 89 | 86 | 85 | 0.4 | 0.6 | 0.9 | 0.7 | 2.9 | - 2.0 | 10 | 3.7 | 3.3 | 7.7 | 2† | 2.2† | |
| 201724 | 108 | 106 | 105 | 0.6 | 0.5 | 0.6 | 0.8 | 2.1 | - 0.9 | 6.9 | 5.6 | 6.6 | 5.3 | 3.7 | 5 | |
| 201725 | 96 | 94 | 93 | 0.5 | 0.4 | 0.7 | - 1.1 | 1.4 | - 2.8 | 7.7 | 9.7 | 3 | 5.7 | 7 | 1.6 | |
| Ca | 201721 | 3.14 | 3.21 | 3.03 | 1.2 | 1.0 | 1.9 | 1.2 | 3.5 | - 1.0 | 5.6* | 4.4* | 3.8* | 3.1 | 1.5† | 2.1† |
| 201722 | 1.84 | 1.92 | 1.80 | 1.2 | 0.8 | 1.7 | 1.2 | 4.4 | - 1.3 | 10.5* | 10.9* | 7.4* | 3.3 | 0.8† | 2.2† | |
| 201723 | 2.73 | 2.82 | 2.67 | 0.8 | 0.8 | 1.3 | 1.1 | 3.8 | - 1.5 | 10.4* | 6.5* | 5.9* | 5 | 1.5† | 2.7† | |
| 201724 | 3.02 | 3.12 | 2.92 | 0.8 | 0.7 | 1.2 | 0.8 | 4.0 | - 2.0 | 9.1* | 6.0* | 5.3* | 5.1 | 1.4† | 2.5† | |
| 201725 | 2.72 | 2.81 | 2.65 | 0.6 | 0.7 | 0.9 | 0.0 | 2.1 | - 3.4 | 14.7* | 9.9* | 6.5* | 8.8 | 4.2 | 1.7† | |
| *TEa calculated by using absolute bias to calculate σ; not marked indicates using percentage bias to calculate σ. † Sigma values < 3. TEaCLIA - allowable total error derived from US Clinical Laboratory Improvement Amendments 1988 (CLIA ‘88). TEaWS/T - allowable total error derived from the People’s Republic of China Health Industry Standard (WS/T403-2012). Alb - albumin, g/L. ALT - alanine aminotransferase, U/L 37 °C. BT - bilirubin, total, µmol/L. Glc - glucose, mmol/L. CREA - creatinine, µmol/L. Urea, mmol/L. K - potassium, mmol/L. Na - sodium, mmol/L. Cl - chlorides, mmol/L. Ca - calcium, mmol/L. | ||||||||||||||||