TABLE 2.
Performance of the VirClia and Platelia GM Ag assays
| Comparison and cutoff value(s)a | Area under ROC curve (95% CI) | Sensitivity (%) | Specificity (%) |
|---|---|---|---|
| Probable IPA vs no IPA | |||
| GM CLIA ODI of ≥0.160 | 0.80 (0.70–0.89) | 68 (56–78) | 100 (76–100) |
| GM CLIA ODI of ≥0.180 | 66 (55–77) | 100 (76–100) | |
| GM CLIA ODI of ≥0.200 | 61 (50–73) | 100 (76–100) | |
| GM EIA ODI of ≥0.5 | 0.87 (0.79–0.95) | 74 (64–84) | 92 (65–100) |
| GM EIA ODI of ≥0.8 | 69 (58–79) | 100 (76–100) | |
| GM EIA ODI of ≥1.0 | 63 (52–74) | 100 (76–100) | |
| Probable IPA vs possible IPA plus no IPA | |||
| GM CLIA ODI of ≥0.160 | 0.81 (0.73–0.88) | 68 (56–78) | 82 (74–92) |
| GM CLIA ODI of ≥0.180 | 66 (55–77) | 86 (79–94) | |
| GM CLIA ODI of ≥0.200 | 61 (50–73) | 86 (79–94) | |
| GM EIA ODI of ≥0.5 | 0.86 (0.80–0.93) | 74 (64–84) | 81 (73–90) |
| GM EIA ODI of ≥0.8 | 69 (58–79) | 97 (90–99) | |
| GM EIA ODI of ≥1.0 | 63 (52–74) | 100 (95–100) | |
| Probable IPA vs no IPA with GM excluded | |||
| GM CLIA ODI of ≥0.160 | 0.77 (0.67–0.88) | 67 (54–78) | 92 (65–100) |
| GM CLIA ODI of ≥0.180 | 65 (52–76) | 100 (76–100) | |
| GM CLIA ODI of ≥0.200 | 63 (50–74) | 100 (76–100) | |
| GM EIA ODI of ≥0.5 | 0.85 (0.76–0.94) | 72 (59–82) | 92 (65–100) |
| GM EIA ODI of ≥0.8 | 65 (52–76) | 100 (76–100) | |
| GM EIA ODI of ≥1.0 | 58 (45–70) | 100 (76–100) | |
| Probable IPA vs possible IPA plus no IPA with GM excluded | |||
| GM CLIA ODI of ≥0.160 | 0.75 (0.67–0.84) | 67 (54–78) | 79 (67–85) |
| GM CLIA ODI of ≥0.180 | 65 (52–76) | 82 (73–89) | |
| GM CLIA ODI of ≥0.200 | 63 (50–74) | 82 (73–89) | |
| GM EIA ODI of ≥0.5 | 0.77 (0.69–0.86) | 71 (59–82) | 73 (63–81) |
| GM EIA ODI of ≥0.8 | 64 (51–76) | 86 (77–91) | |
| GM EIA ODI of ≥1.0 | 57 (44–69) | 88 (80–93) | |
| GM EIA ODI of ≥1.0 and GM CLIA ODI of ≥0.200 | 52 (39–65) | 92 (85–96) | |
| GM EIA ODI of ≥1.0 or GM CLIA ODI of ≥0.200 | 67 (54–78) | 77 (68–85) |
The performance of the Platelia GM assay (EIA) and the VirClia GM assay (CLIA) were calculated for probable IPA with controls. Controls were defined either as patients with no IPA or as patients with no IPA in combination with patients with possible IPA. Patients were classified as having proven IPA, probable IPA, possible IPA, or no IPA using the 2020 EORTC/MSGERC criteria and using the same 2020 EORTC/MSGERC criteria but with the exclusion of GM as a mycological criterion.