Table 4.
Summarized characteristics of newly developed C1-INH complex assays.
| C1s/C1-INH complex assay | MASP-1/C1-INH complex assay | |
|---|---|---|
| Standard range | 100.0 – 1.6 ng/mL | 25.0 – 0.4 ng/mL |
|
Limit of quantification
ULoQ LLoQ |
100.0 ng/mL 0.2 ng/mL |
50 ng/mL 0.06 ng/mL |
| cross-reactivity with uncomplexed components | no | no |
|
cross-reactivity with animal serum
(mouse, rat, horse, pig, dog) |
mouse | no |
| Inter-assay variation | < 10% | < 10% |
| Intra-assay variation | < 10% | < 10% |
|
Matrices to be used
(minimal required dilution) |
EDTA plasma (100x) Citrate plasma (100x) Heparin plasma (200x) Serum (200x) |
EDTA plasma (5x) Citrate plasma (5x) Heparin plasma (5x) Serum (10x) |
| Measured complex concentration in healthy individuals, n=96 | 1846 ± 1060 ng/mL [mean ± 2SD] |
40.5 (13.8-87.9) ng/mL [median (2.5-97.5 percentile range)] |
EDTA, ethylenediaminetetraacetic acid; ULoQ, upper limit of quantification; LLoQ, lower limit of quantification; SD, standard deviation.