Table 3.
Performances of the detection strategies for diagnosing congenital CMV infection in newborns
| cCMV-positive (n=49) | cCMV- negative (n=6185) | Total (n=6234) | Sensitivity (95% CI)-% | Specificity (95% CI)-% | Youden index | Positive predictive value* (95% CI)-% | Negative predictive value* (95% CI)-% | Positive likelihood ratio (95% CI) | Negative likelihood ratio (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Saliva and urine screening with saliva and urine confirmation (Strategy 1, the reference) | ||||||||||
| Positive | 49 | 0 | 49 | 100.0 | 100.0 | 1.00 | 100.0 | 100.0 | - | - |
| Negative | 0 | 6185 | 6185 | |||||||
| Saliva only screening (Strategy 2) | ||||||||||
| Positive | 42 | 102 | 144 | 85.7 (73.3, 92.8) | 98.4 (98.0, 98.6) | 0.84 | 29.2 (22.4, 37.1) | 99.9 (99.8, 99.9) | 52.0 (50.6, 53.4) | 0.15 (0.11, 0.19) |
| Negative | 7 | 6083 | 6090 | |||||||
| Urine only screening (Strategy 3) | ||||||||||
| Positive | 14 | 25 | 39 | 28.6 (17.9, 42.4) | 99.6 (99.4, 99.7) | 0.28 | 35.9 (22.7, 51.6) | 99.4 (99.2, 99.6) | 70.7 (46.1, 108.5) | 0.72 (0.68, 0.76) |
| Negative | 35 | 6160 | 6195 | |||||||
| Saliva and urine screening (Strategy 4) | ||||||||||
| Positive | 49 | 122 | 171 | 100.0 (92.7, 100) | 98.0 (97.7, 98.4) | 0.98 | 28.7 (22.4, 35.8) | 100.0 (99.9, 100.0) | 50.7 (49.9 – 51.5) | 0.0 (0.0, -) |
| Negative | 0 | 6063 | 6063 | |||||||
| Saliva screening with saliva confirmation (Strategy 5) | ||||||||||
| Positive | 39 | 0 | 39 | 79.6 (66.4, 88.5) | 100.0 (99.9, 100.0) | 0.80 | 100.0 (91.0, 100.0) | 99.8 (99.7, 99.9) | - | 0.20 (0.17, 0.25) |
| Negative | 10 | 6185 | 6195 | |||||||
| Saliva screening with urine confirmation (Strategy 6) | ||||||||||
| Positive | 12 | 0 | 12 | 24.5 (14.6, 38.1) | 100.0 (99.9, 100.0) | 0.24 | 100.0 (75.7, 100.0) | 99.4 (99.2, 99.6) | - | 0.76 (0.72, 0.80) |
| Negative | 37 | 6185 | 6222 | |||||||
| Saliva screening with saliva and urine confirmation (Strategy 7) | ||||||||||
| Positive | 42 | 0 | 42 | 85.7 (73.3, 92.9) | 100.0 (99.9, 100.0) | 0.86 | 100.0 (91.6, 100.0) | 99.9 (99.8, 100.0) | - | 0.14 (0.11, 0.19) |
| Negative | 7 | 6185 | 6192 | |||||||
| Urine screening with urine confirmation (Strategy 8) | ||||||||||
| Positive | 12 | 0 | 12 | 24.5 (14.6, 38.1) | 100.0 (99.9, 100.0) | 0.24 | 100.0 (75.7, 100.0) | 99.4 (99.2, 99.6) | - | 0.76 (0.72, 0.80) |
| Negative | 37 | 6185 | 6222 | |||||||
| Urine screening with saliva confirmation (Strategy 9) | ||||||||||
| Positive | 14 | 0 | 14 | 28.6 (17.9, 42.4) | 100.0 (99.9, 100.0) | 0.29 | 100.0 (78.5, 100.0) | 99.4 (99.2, 99.6) | - | 0.71 (0.68, 0.76) |
| Negative | 35 | 6185 | 6220 | |||||||
| Urine screening with saliva and urine confirmation (Strategy 10) | ||||||||||
| Positive | 14 | 0 | 14 | 28.6 (17.9, 42.4) | 100.0 (99.9, 100.0) | 0.29 | 100.0 (78.5, 100.0) | 99.4 (99.2, 99.6) | - | 0.71 (0.68, 0.76) |
| Negative | 35 | 6185 | 6220 | |||||||
| Saliva and urine screening with saliva confirmation (Strategy 11) | ||||||||||
| Positive | 46 | 0 | 46 | 93.9 (83.5, 97.9) | 100.0 (99.9, 100.0) | 0.94 | 100.0 (92.3, 100.0) | 100.0 (99.9, 100.0) | - | 0.06 (0.03, 0.12) |
| Negative | 3 | 6185 | 6188 | |||||||
| Saliva and urine screening with urine confirmation (Strategy 12) | ||||||||||
| Positive | 17 | 0 | 17 | 34.7 (22.9, 48.7) | 100.0 (99.9, 100.0) | 0.35 | 100.0 (81.6, 100.0) | 99.5 (99.3, 99.6) | - | 0.65 (0.61 – 0.69) |
| Negative | 32 | 6185 | 6217 | |||||||
Note: *Predictive indices would be influenced by disease prevalence, and the predicative indices calculated here were based on the cCMV prevalence of about 1.3%