Table 4.
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