Table 4.
Comparison of ELISA and CLIA with TPPA Using Serum Specimens
| TPPA results (N) | ||||||
|---|---|---|---|---|---|---|
| Assays and results | Negative | Positive | %Sensitivity (95% CI) | %Specificity (95% CI) | %agreement (95% CI) | Kappa values (P‐value) |
| CLIA | 91.11 | 98.45 | 96.28 | 0.967 | ||
| (88.33–93.54) | (97.12–99.38) | (94.35–97.82) | (P ≤ 0.001) | |||
| Negative | 317 | 3 | ||||
| Positive | 3 | 123 | ||||
| Equivocal | 2 | 9 | ||||
| Low valuea | 1 | 0 | ||||
| High valueb | 1 | 9 | ||||
| ELISA | 87.40 | 99.37 | 93.44 | 0.897 | ||
| (84.20–90.28) | (98.44–99.89) | (90.99–95.52) | (P ≤ 0.001) | |||
| Negative | 316 | 16 | ||||
| Positive | 2 | 111 | ||||
| Equivocal | 4 | 8 | ||||
| Low valuea | 4 | 7 | ||||
| High valueb | 0 | 1 | ||||
a
Value was lower than the manufacturer's cutoff of CLIA or ELISA.
b
Value was higher than the manufacturer's cutoff of CLIA or ELISA.