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. 2017 Feb 8;36(7):1253–1259. doi: 10.1007/s10096-017-2916-9

Table 4.

GDH/toxin A&B algorithm by EIAs and CLIAs compared to cell cytotoxicity assay

Assay Finding Cell cytotoxicity assay % Sensitivity (95% CI) % Specificity (95% CI) % PPV (95% CI) % NPV (95% CI)
Positive Negative
EIAs Positivea 18 1 72.0 (50.4–87.1) 99.6 (97.7–100) 94.7 (71.9–99.7) 97.5 (94.7–98.9)
Negativeb 7c 274
CLIAs Positivea 22 2 88.0 (67.7–96.8) 99.3 (97.1–99.9) 91.7 (71.5–98.5) 98.9 (96.6–99.7)
Negativeb 3c 273

CLIA chemiluminescent immunoassays, EIA enzyme immunoassays, CI confidence interval, PPV positive predictive values, NPV negative predictive values

aPositive GDH assay confirmed by the toxin assay

bEither one of the assays or both assays negative

cTrue positive GDH assay and negative toxin assay