TABLE 3.
Parameter | %CV for sample (geometric mean concn [EU/ml]) |
||||||
---|---|---|---|---|---|---|---|
S1 (49) | S2 (58) | S3 (83) | S4 (100) | S5 (135) | S6 (204) | S7 (217) | |
Intra-assay precision | |||||||
Analyst 1 | 22 | 25 | 18 | 15 | 24 | 15 | 21 |
Analyst 2 | 16 | 12 | 8 | 10 | 13 | 15 | 13 |
Analyst 3 | 12 | 10 | 15 | 10 | 14 | 14 | 13 |
Analyst 4 | 12 | 12 | 11 | 12 | 14 | 12 | 14 |
Analyst 5 | 16 | 16 | 18 | 21 | 17 | 19 | 18 |
Analyst 6 | 17 | 14 | 13 | 13 | 16 | 12 | 27 |
Interassay precision | |||||||
Site A | 22 | 23 | 22 | 24 | 23 | 23 | 26 |
Site B | 21 | 29 | 23 | 21 | 25 | 21 | 26 |
Site Bb | 16 | 17 | 15 | 16 | 18 | 19 | 22 |
Reproducibility | |||||||
Site-to-site | 23 | 28 | 23 | 23 | 27 | 25 | 29 |
Site-to-sitec | 20 | 22 | 20 | 21 | 23 | 23 | 27 |
Samples are ordered from low to high concentrations. Boldface (samples 2 to 5) indicates those samples with an IgG anti-PT concentration in the range analyzed under the prespecified acceptance criteria (50 to 200 EU/ml).
Interassay precision without analyst 1 from site B.
Reproducibility without analyst 1 from site B.