Table 4.
The table summarizes the percent change in the mean test values after adding biotin solution to pooled serum with gradient levels, analyzed using Roche reagents and Cobas e602 instrument.
| Onboard Elecsys Reagent |
Change (%) after biotin (ng/mL) spike-in |
|||||||
|---|---|---|---|---|---|---|---|---|
| Tests | PBS | 500 | 1000 | 1500 | 2000 | 2500 | 3000 | |
|
CEA (Older reagent) |
Mean | 0 % | −23 % | −65 % | −92 % | −95 % | −97 % | −97 % |
| SD | ±1.2 % | ±1.9 % | ±1.7 % | ±0.3 % | ±0.2 % | ±0.1 % | ±0.0 % | |
| CA125 (Older reagent) | Mean | 0 % | −23 % | −65 % | −92 % | −95 % | −97 % | −97 % |
| SD | ±1.7 % | ±1.5 % | ±1.0 % | ±0.6 % | ±0.4 % | ±0.4 % | ±0.3 % | |
| CA153 (Older reagent) | Mean | 0 % | −49 % | −56 % | −67 % | −73 % | −77 % | −79 % |
| SD | ±1.9 % | ±1.2 % | ±6.1 % | ±1.3 % | ±0.6 % | ±0.6 % | ±0.3 % | |
| AFP (Newer reagent) | Mean | 0 % | −2.3 % | −1.1 % | −0.2 % | 1.4 % | 0.7 % | −1.0 % |
| SD | ±1.0 % | ±1.3 % | ±2.0 % | ±0.7 % | ±1.2 % | ±0.6 % | ±0.8 % | |
| CA199 (Older reagent) | Mean | 0 % | −2.3 % | −44 % | −77 % | −88 % | −94 % | −97 % |
| SD | ±0.7 % | ±1.3 % | ±3.2 % | ±0.1 % | ±0.6 % | ±0.3 % | ±0.2 % | |
| FPSA (Newer reagent) | Mean | 0 % | 0.3 % | −5.1 % | −9.2 % | −13 % | −21 % | −32 % |
| SD | ±4.3 % | ±4.5 % | ±3.2 % | ±2.6 % | ±3.6 % | ±4.4 % | ±2.7 % | |
|
TPSA (Newer reagent) |
Mean | 0 % | 0.8 % | 2.3 % | 0 % | −3.1 % | −7.6 % | −13 % |
| SD | ±1.3 % | ±2.4 % | ±1.6 % | ±1.1 % | ±3.8 % | ±4.1 % | ±4.0 % | |
|
ATG (Newer reagent) |
Mean | 0 % | −0.3 % | 5.5 % | 11 % | 14 % | 21 % | 30 % |
| SD | ±0.7 % | ±2.4 % | ±1.5 % | ±3.9 % | ±4.2 % | ±2.8 % | ±4.3 % | |
|
FT4 (Newer reagent) |
Mean | 0 % | 0.3 % | −0.6 % | 2.6 % | 2.2 % | 3.3 % | 4.2 % |
| SD | ±1.1 % | ±0.7 % | ±2.0 % | ±1.7 % | ±1.3 % | ±3.0 % | ±3.4 % | |
|
TSH (Newer reagent) |
Mean | 0 % | 8.4 % | 4.3 % | −6.6 % | −23 % | −42 % | −61 % |
| SD | ±0.1 % | ±1.2 % | ±1.6 % | ±0.9 % | ±0.5 % | ±1.2 % | ±1.4 % | |
|
TG (Newer reagent) |
Mean | 0 % | 2.9 % | −0.4 % | −6.6 % | −12 % | −20 % | −28 % |
| SD | ±1.0 % | ±3.1 % | ±0.5 % | ±1.5 % | ±1.6 % | ±3.0 % | ±2.1 % | |
| HBeAg (Older reagent) | Mean | 0 % | 52 % | 54 % | 48 % | 52 % | 54 % | 48 % |
| SD | ±0.9 % | ±7.8 % | ±9.2 % | ±6.1 % | ±3.3 % | ±2.9 % | ±6.0 % | |
|
HBsAg (Newer reagent) |
Mean | 0 % | −2 % | −12 % | −21 % | −29 % | −41 % | −52 % |
| SD | ±3.0 % | ±5.4 % | ±7.9 % | ±8.4 % | ±6.4 % | ±6.4 % | ±4.9 % | |
Each assay provides the mean value derived from triplicates at each concentration of biotin for calculating the percent change = [(biotin-added) – PBS]/PBS.