TABLE 2.
Performance characteristics of latest-generation and FDA-cleared IgG serological assays compared to Trypanosoma cruzi infection status determined by American Red Cross screening and confirmation algorithm at the time of donation
| Assaya | Among 448 ARC-positive specimens |
Among 262 ARC-negative specimens |
AUC (% [95% CI])c | ||
|---|---|---|---|---|---|
| No. positive | Sensitivity (% [95% CI])b | No. negative | Specificity (% [95% CI])b | ||
| ELISA | |||||
| Wiener Lisado | 435 | 97.1 (95.1–98.4) | 262 | 100 (98.6–100.0) | 0.99 (0.97–0.99) |
| Wiener v.4.0 | 443 | 98.9 (97.4–99.6) | 262 | 100 (98.6–100.0) | 0.99 (0.99–1.00) |
| Wiener v.3.0 | 422d | 94.2 (94.6–96.2) | 261 | 99.6 (97.9–100.0) | 0.97 (0.95–0.98) |
| Hemagen | 393e | 87.7 (84.3–90.6) | 262 | 100 (98.6–100.0) | 0.94 (0.92–0.95) |
| Ortho | 416 | 92.9 (90.1–95.1) | 262 | 100 (98.6–100.0) | 0.96 (0.95–0.98) |
| LFA | |||||
| InBios CDP | 437 | 97.5 (95.6–98.8) | 239 | 91.2 (87.1–94.4) | 0.94 (0.92–0.96) |
| ChLIA | |||||
| Abbott PRISM | 428 | 95.5 (93.2–97.3) | 262 | 100 (98.6–100.0) | 0.98 (0.96–0.99) |
a
ELISA, enzyme-linked immunosorbent assay; LFA, lateral flow assay; ChLIA, chemiluminescent assay.
b
Binomial exact 95% confidence interval.
c
AUC, area under the curve of receiver operating characteristics.
d
Data include 5 specimens with indeterminate results. Indeterminate results were classified as positive results for the purpose of these analyses (see text for explanation).
e
Data include 9 specimens with indeterminate results.