Table 1.
Intra- and inter-assay precision and accuracy for IgG, IgM, and IgA
| QC samples | Intra-assay precision (CV%) | Intra-assay accuracy (% bias) | QC samples | Inter-assay precision (CV%) | Inter-assay accuracy (% bias) |
|---|---|---|---|---|---|
| IgG | IgG | ||||
| LLOQ (3.2 ng/mL) | 12.3 | −17.1 | LLOQ (3.9 ng/mL) | 19.1 | −16.5 |
| Low QC (7.2 ng/mL) | 10.7 | −16.7 | LQC (8.6 ng/mL) | 18.6 | −7.7 |
| Middle QC (14.2 ng/mL) | 9.5 | −8.6 | MQC (15.6 ng/mL) | 19.9 | −16.9 |
| High QC (33.5 ng/mL) | 6.7 | −2.3 | HQC (34.3 ng/mL) | 15.2 | −8.7 |
| ULOQ (57.7 ng/mL) | 17.1 | −9.2 | ULOQ (63.5 ng/mL) | 16.5 | −15.3 |
| IgM | IgM | ||||
| LLOQ (43.4 ng/mL) | 7.1 | 11.8 | LLOQ (49.3 ng/mL) | 14.0 | 5.1 |
| Low QC (91.8 ng/mL) | 4.4 | −8.7 | LQC (100.5 ng/mL) | 7.5 | 7.2 |
| Middle QC (190.8 ng/mL) | 4.2 | −5.3 | MQC (201.6 ng/mL) | 5.9 | 7.5 |
| High QC (371.2 ng/mL) | 3.6 | −5.4 | HQC (392.3 ng/mL) | 6.6 | 4.6 |
| ULOQ (791.8 ng/mL) | 4.3 | −1.3 | ULOQ (802.5 ng/mL) | 5.9 | 7.0 |
| IgA | IgA | ||||
| LLOQ (4.0 ng/mL) | 3.7 | −9.3 | LLOQ (4.5 ng/mL) | 11.1 | −4.9 |
| Low QC (8.5 ng/mL) | 2.7 | −5.9 | Low QC (9.0 ng/mL) | 7.0 | −3.8 |
| Middle QC (17.0 ng/mL) | 2.6 | −3.9 | Middle QC (17.7 ng/mL) | 5.8 | −5.5 |
| High QC (35.3 ng/mL) | 2.8 | −2.7 | High QC (36.3 ng/mL) | 4.9 | −3.3 |
| ULOQ (71.9 ng/mL) | 3.5 | −1.5 | ULOQ (73.0 ng/mL) | 4.4 | −2.6 |
CV coefficient of variation, LLOQ lower limit of quantitation, QC quality control, LQC low range of the dynamic range QC, MQC middle of the dynamic range QC, HQC high range of the dynamic range QC, QC quality control, ULOQ upper limit of quantitation