Skip to main content
. 2019 Nov 22;57(12):e01217-19. doi: 10.1128/JCM.01217-19

TABLE 2.

Performance of FDA-cleared Chagas disease IgG serological assays compared to original blood donor status, consensus among current tests, and latent class analysis

Assaya Value(s)
Blood donor status
Consensus status
Latent class analysis
Positive Negative Positive Negative
Hemagen ELISA
    No. of positive specimens 440b 0 439b 1
    No. of negative specimens 60 300 45 315
Sensitivity (%) (95% CI) 88.00 (84.82, 90.72) 90.70 (87.76, 93.14) 92.04 (88.93, 95.04)
Specificity (%) (95% CI) 100.00 (98.88, 100.00) 99.68 (98.25, 99.99) 99.04 (97.20, 100.00)
PPV (%) (95% CI) 100.00 (99.17, 100.00) 99.77 (98.74, 99.99)
NPV (%) (95% CI) 83.33 (79.07, 87.03) 87.50 (83.63, 90.73)
Ortho ELISA
    No. of positive specimens 462 0 461 1
    No. of negative specimens 38 300 23 315
Sensitivity (%) (95% CI) 92.40 (89.72, 94.57) 95.25 (92.95, 96.96) 96.50 (94.20, 99.29)
Specificity (%) (95% CI) 100.00 (98.78, 100.00) 99.68 (98.25, 99.99) 98.82 (96.25, 100.00)
PPV (%) (95% CI) 100.00 (99.20, 100.00) 99.78 (98.80, 99.99)
NPV (%) (95% CI) 88.76 (84.90, 91.92) 93.20 (89.96, 95.64)
Wiener ELISA
    No. of positive specimens 470c 2d 466e 6f
    No. of negative specimens 30 298 18 310
Sensitivity (%) (95% CI) 94.00 (91.55, 95.92) 96.28 (94.19, 97.78) 97.12 (94.81, 99.24)
Specificity (%) (95% CI) 99.33 (97.61, 99.92) 98.10 (95.91, 99.30) 96.67 (93.92, 98.96)
PPV (%) (95% CI) 99.58 (98.48, 99.95) 98.73 (97.25, 99.53)
NPV (%) (95% CI) 90.85 (87.20, 93.74) 94.51 (91.47, 96.72)
InBios CDP
    No. of positive specimens 487 23 480 30
    No. of negative specimens 13 277 4 286
Sensitivity (%) (95% CI) 97.40 (95.59, 98.61) 99.17 (97.90, 99.77) 99.29 (98.34, 100.00)
Specificity (%) (95% CI) 92.33 (88.82, 95.08) 90.51 (86.72, 93.50) 87.53 (82.24, 91.94)
PPV (%) (95% CI) 95.49 (93.31, 97.12) 94.12 (91.71, 96.00)
NPV (%) (95% CI) 95.52 (92.46, 97.59) 98.62 (96.51, 99.62)
a

NPV, negative predictive value; PPV, positive predictive value.

b

Data include 11 specimens with indeterminate results. Indeterminate results were classified as positive results for the purpose of these analyses (see text for explanation).

c

Data include 4 specimens with indeterminate results.

d

These 2 specimens had indeterminate results.

e

Data include 3 specimens with indeterminate results.

f

Data include 3 specimens with indeterminate results.