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. 2015 Aug 1;35(6):573–582. doi: 10.1007/s10875-015-0184-y

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