Table 2.
Performance indicators of the different pepsinogen test-systems based on varying cutoffs
| Test-system (method) | Analytical Approach | Sensitivity, % (95% CI) | Specificity, % (95% CI) | Overall accuracya, % (95% CI) |
|---|---|---|---|---|
| Biohit (ELISA) | Manufacturer’s (PgI/PgII<3) | 44.0 (30.2-57.8) | 90.6 (88.5-92.7) | 87.7 (85.4-90.0) |
| ROC-defined cutoff (PgI/PgII<6.9) | 70.0 (57.3-82.7) | 62.6 (59.2-66.1) | 63.1 (59.8-66.4) | |
| DTC-optimized (PgI<23 and PgI/PgII<6) | 48.0 (34.2-61.9) | 93.1 (91.3-94.9) | 90.3 (88.3-92.4) | |
| Vector Best (ELISA) | Manufacturer’s (PgI/PgII<3) | 56.0 (42.2-69.8) | 83.7 (81.1-86.3) | 82.0 (79.3-84.6) |
| ROC-defined cutoff (PgI/PgII<4.1) | 70.0 (57.3-82.7) | 71.5 (68.3-74.7) | 71.4 (68.3-74.6) | |
| DTC-optimized (PgI<42.9) | 52.0 (38.2-65.9) | 91.8 (89.8-93.8) | 89.3 (87.2-91.5) | |
| Eiken (Latex-agglutination) | Manufacturer’s (PgI≤70 ng/ml and PgI/PgII≤3) | 76.0 (64.2-87.8) | 68.9 (65.6-72.2) | 69.3 (66.1-72.5) |
| Manufacturer’s for strong positivity (PgI≤30 ng/ml and PgI/PgII≤2) | 52.0 (38.2-65.9) | 89.8 (87.6-92.0) | 87.5 (85.2-89.7) | |
| ROC-defined cutoff (PgI/PgII<2.7) | 70.0 (57.3-82.7) | 71.9 (68.7-75.1) | 71.8 (68.7-74.9) | |
| DTC-optimized (PgI<50 and PgI/PgII<2.3) | 58.0 (44.3-71.7) | 83.7 (81.1-86.3) | 82.1 (79.5-84.7) |
a
Sensitivity x Prevalence + Specificity (1 - Prevalence); Prevalence of atrophy=6.2% (50/805)
Abbreviations: CI – Confidence Interval; DTC – Decision tree classifier; ELISA -enzyme linked immunosorbent assay; ROC – Receiver Operating Characteristic; PgI – Pepsinogen I; PgII – Pepsinogen II