Table 3.
Method comparison between the Alinity i system and Architect i2000sr.
| Assay | Unit | n | Deming |
R2 |
TEa (%) |
vs. Architect |
||
|---|---|---|---|---|---|---|---|---|
| Slope (95% CI) | Intercept (95%CI) | Mean %bias | Decision | |||||
| TSH | uIU/mL | 50 | 1.079 (1.071, 1.087) | −0.220 (−0.307, −0.133) | 0.9994 | 23.7 | 2.75 | Equivalent |
| TT3 | ng/mL | 50 | 1.003 (0.985, 1.022) | 1.745 (−0.411, 3.900) | 0.9960 | 9.22 | 1.94 | Equivalent |
| FT3 | pg/mL | 60 | 0.867 (0.847, 0.886) | 0.217 (0.109, 0.325) | 0.9928 | 11.3 | −8.09 | Equivalent |
| TT4 | ug/mL | 60 | 0.958 (0.940, 0.977) | 0.322 (0.115, 0.529) | 0.9946 | 7.0 | −1.09 | Equivalent |
| FT4 | ng/dL | 50 | 0.962 (0.940, 0.984) | 0.001 (−0.026, 0.028) | 0.9938 | 8.0 | −3.84 | Equivalent |
| Anti-TPO | IU/mL | 50 | 1.067 (1.059, 1.074) | −1.718 (−3.178, −0.259) | 0.9994 | 46.2 | 4.37 | Equivalent |
| AFP | ng/mL | 50 | 0.985 (0.980, 0.990) | 0.343 (−0.318, 1.005) | 0.9996 | 21.9 | −0.86 | Equivalent |
| CEA | ng/mL | 50 | 1.003 (0.999, 1.007) | −0.220 (−0.634, 0.194) | 0.9998 | 24.7 | −0.27 | Equivalent |
| CA 19-9 | U/mL | 50 | 1.002 (0.990, 1.013) | 0.433 (−3.141, 4.007) | 0.9984 | 46.03 | 0.42 | Equivalent |
| CA 125 | U/mL | 50 | 0.964 (0.958, 0.971) | 0.21 (−0.75, 1.18) | 0.9994 | 35.4 | −3.40 | Equivalent |
| CA 15-3 | U/mL | 50 | 0.983 (0.972, 0.993) | 0.94 (−0.38, 2.26) | 0.9986 | 20.8 | −0.04 | Equivalent |
| HE 4 | pmol/L | 50 | 1.033 (1.019, 1.047) | −0.11 (−4.42, 4.20) | 0.9980 | 10.0a | 3.19 | Equivalent |
| TPSA | ng/mL | 50 | 1.040 (1.035, 1.044) | 0.043 (−0.016, 0.102) | 0.9998 | 33.6 | 4.52 | Equivalent |
| FPSA | ng/mL | 54 | 0.992 (0.982, 1.003) | −0.068 (−0.092, −0.044) | 0.9986 | 8.0a | −5.91 | Equivalent |
| Testosterone | ng/mL | 50 | 0.997 (0.987, 1.008) | −0.012 (−0.064, 0.040) | 0.9986 | 13.61 | −0.58 | Equivalent |
| Progesterone | ng/mL | 50 | 0.974 (0.967, 0.981) | −0.10 (−0.16, −0.03) | 0.9994 | 7.0a | −4.46 | Equivalent |
| E2 | pg/mL | 50 | 1.028 (1.017, 1.038) | −3.0 (−6.4, 0.4) | 0.9988 | 26.86 | 1.40 | Equivalent |
| Prolactin | ng/mL | 50 | 1.058 (1.046, 1.069) | 0.077 (−0.162, 0.316) | 0.9986 | 29.4 | 6.08 | Equivalent |
| b-HCG | mIU/mL | 52 | 0.952 (0.951, 0.954) | 5.788 (1.100, 10.477) | 1.0000 | 10.0a | −4.16 | Equivalent |
| FSH | ng/mL | 50 | 0.973 (0.954, 0.993) | −0.717 (−1.914, 0.479) | 0.9954 | 21.19 | −4.22 | Equivalent |
| LH | mIU/mL | 50 | 0.978 (0.968, 0.988) | −0.035 (−0.271, 0.201) | 0.9988 | 27.92 | −2.40 | Equivalent |
| Cortisol | ug/dL | 50 | 1.012 (1.001, 1.023) | −0.14 (−0.29, 0.00) | 0.9984 | 22.8 | −0.19 | Equivalent |
| hsTnI | pg/mL | 50 | 0.957 (0.951, 0.963) | −0.006 (−0.060, 0.049) | 0.9996 | 10.0a | −4.55 | Equivalent |
| BNP | pg/mL | 50 | 0.977 (0.966, 0.989) | 4.02 (−5.92, 13.97) | 0.9984 | 12.0a | −1.27 | Equivalent |
| Ferritin | ng/mL | 50 | 1.104 (1.091, 1.117) | −0.853 (−4.573, 2.866) | 0.9984 | 16.9 | 9.43 | Equivalent |
| iPTH | pg/mL | 60 | 1.043 (1.035, 1.052) | −2.50 (−5.62, 0.63) | 0.9990 | 7.0a | 2.91 | Equivalent |
| Folate | ng/mL | 50 | 1.085 (1.004, 1.166) | 0.30 (−0.55, 1.15) | 0.9434 | 39.0 | 11.08 | Equivalent |
| Vitamin B12 | pg/mL | 50 | 1.055 (1.019, 1.091) | −17.3 (−45.4, 10.9) | 0.9868 | 30.0 | 3.0 | Equivalent |
| Vitamin D | ng/mL | 60 | 1.023 (1.004–1.042) | −0.97 (−1.86, −0.09) | 0.9950 | 30.0 | −0.34 | Equivalent |
| C-peptide | ng/mL | 50 | 0.958 (0.945, 0.972) | 0.076 (0.028, 0.125) | 0.9976 | 20.8 | −1.57 | Equivalent |
| Homocysteine | umol/L | 50 | 0.928 (0.905, 0.950) | 0.133 (−0.164, 0.430) | 0.9932 | 15.48 | −6.31 | Equivalent |
Regression equations were calculated assuming the results from the Alinity i system as Y method and those from the Architect i2000sr as X method..
a
Manufacturer’s claimed values were adopted as total allowable error because the Westgard desirable biological variation database did not clarify the values for these analytes.