Table 2.
Specificity and selectivity of the Ig-DBS assay
IgG | ||||||||
Specificity | Selectivity | |||||||
IgG calibrator captured by anti-IgA | IgG calibrator captured by anti-IgM | |||||||
Matrix | IgG added at 3.1 ng/mL | 37.5 ng/mL | 18.75 ng/mL | 9.38 ng/mL | 37.5 ng/mL | 18.75 ng/mL | 9.38 ng/mL | |
Mean | <LLOQ | 1.9 | 2.6a | 2.8a | 2.4a | 3.2a | 2.5a | 2.2a |
SD | – | 0.2 | – | – | – | – | – | – |
% CV | – | 8.9 | – | – | – | – | – | – |
% accuracy | – | 62.3 | – | – | – | – | – | – |
a<LLOQ of 4.7 ng/mL | ||||||||
IgM | ||||||||
Specificitya | Selectivity | |||||||
IgM calibrator captured by anti-IgA | IgM calibrator captured by anti-IgG | |||||||
Matrix | IgM added at 15.6 ng/mL | 375.0 ng/mL | 187.5 ng/mL | 93.8 ng/mL | 375.0 ng/mL | 187.5 ng/mL | 93.8 ng/mL | |
Mean | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ |
bLLOQ = 46.9 ng/mL | ||||||||
IgA | ||||||||
Specificity | Selectivity | |||||||
IgA calibrator captured by anti-IgG | IgA calibrator captured by anti-IgM | |||||||
Matrix | IgA added at 3.1 ng/mL | 37.5 ng/mL | 18.75 ng/mL | 9.38 ng/mL | 37.5 ng/mL | 18.75 ng/mL | 9.38 ng/mL | |
Mean | <LLOQ | 2.8 | 1.1a | 1.1a | 1.1a | 4.2a | 2.5a | 1.8a |
SD | – | 0.1 | – | – | – | – | – | – |
% CV | – | 3.7 | – | – | – | – | – | – |
% accuracy | – | 88.6 | – | – | – | – | – | – |
a<LLOQ of 4.7 ng/mL |
CV coefficient of variation, LLOQ lower limit of quantitation, SD standard deviation
aThe assay was unable to quantify analyte added to matrix at 15.6 ng/mL as well as in matrix without added analyte, thereby demonstrating specificity
bResults in the assay for all concentrations that are below the LLOQ of 46.9 ng/mL for the assay indicate no selectivity issue