Table 1.
Summary of analytical principles, traceability, and analytical ranges of Cobas Pro (Roche) and Atellica Solution (Siemens) platforms
| Measurand | Platform | Method principle | Traceability | Analytical range |
|---|---|---|---|---|
| LH | Atellica | CLIA (sandwich) | NIBSC 80/552 | 0.07–200 IU/L |
| LH | Cobas Pro | ECLIA (sandwich) | NIBSC 80/552 | 0.3–200 IU/L |
| FSH | Atellica | CLIA | WHO IS 94/632 | 0.3–200 IU/L |
| FSH | Cobas Pro | ECLIA | WHO IRP 78/549 | 0.3–200 IU/L |
| Testosterone | Atellica | CLIA | ID-LC-MS/MS | 0.24–52.05 nmol/L |
| Testosterone | Cobas Pro | ECLIA | ID-GC/MS | 0.087–52.0 nmol/L |
| Estradiol | Atellica | CLIA | ID-GC/MS (manufacturer) | 43.31–11010 pmol/L |
| Estradiol | Cobas Pro | ECLIA | CRM 6004a via ID-GC/MS | 18.4–11010 pmol/L |
Table 2.
Key statistical results across hormones
| Hormone | Spearmanr | Intercept (95% CI) | Slope (95% CI) | Mean Bias (95% CI) | Cusum Test | Clinical Notes |
|---|---|---|---|---|---|---|
| LH | 0.991 | −0.42 (−0.50 to −0.35) | 0.86 (0.84 to 0.87) | −1.55 IU/L (−1.75 to −1.36) | p < 0.01 | Underestimation on Atellica may shift borderline prepubertal values into the prepubertal range |
| FSH | 0.995 | 0.01 (−0.09 to 0.07) | 1.09 (1.07 to 1.10) | +1.35 IU/L (0.92 to 1.78) | p = 0.87 | Proportional bias; use caution when switching platforms |
| Estradiol (peds) | 0.898 | 33.29 (26.55 to 39.02) | 0.95 (0.91 to 0.97) | +33.75 pmol/L (16.63 to 50.88) | p = 0.11 | Atellica quantifies more low-end results; may influence pubertal staging |
| Estradiol (adult) | 0.968 | 22.30 (13.66 to 29.11) | 1.06 (1.04 to 1.08) | +142.18 pmol/L (97.91 to 186.46) | p = 0.05 | Substantial overestimation on Atellica |
| Testosterone | 0.982 | −0.27 (−0.39 to −0.15) | 0.99 (0.97 to 1.02) | Minimal | p = 0.01 | Good agreement; non-linearity at low concentrations |
Figure 1.
Passing–Bablok regression and Bland-Altman analysis comparing LH concentrations between Atellica Solution and Cobas Pro platforms using 132 pediatric serum samples.
Figure 2.
Comparison of FSH concentrations between Atellica Solution and Cobas Pro platforms using 140 pediatric serum samples.
Figure 3.
Comparison of estradiol concentrations between Atellica Solution and Cobas Pro platforms in 181 pediatric serum samples.
Figure 4.
Comparison of estradiol concentrations in 125 adult female samples measured by Atellica Solution and Cobas Pro.
Figure 5.
Comparison of testosterone concentrations between Atellica Solution and Cobas Pro platforms using 125 pediatric and adolescent serum samples.