Table 2.
Diagnostic performance of the ClassEC test.
| Clinician-collected samples |
Self-collected samples |
|||||||
|---|---|---|---|---|---|---|---|---|
| Training |
Validation |
Overall |
Validation |
|||||
| Cases | Controls | Cases | Controls | Cases | Controls | Cases | Controls | |
| Test positive | 67 | 14 | 27 | 6 | 94 | 20 | 66 | 2 |
| Test negative | 23 | 55 | 12 | 24 | 35 | 79 | 24 | 19 |
| Sensitivity, % (95% CI) | 74 (64, 83) | 69 (52, 83) | 73 (64, 80) | 73 (63, 82) | ||||
| Specificity, % (95% CI) | 79 (68, 88) | 80 (61, 92) | 80 (71, 87) | 90 (70, 99) | ||||
| PPV, % (95% CI)a | 27 (18, 37) | 25 (14, 42) | 26 (20, 35) | 43 (17, 74) | ||||
| NPV, % (95% CI)a | 97 (96, 98) | 96 (94, 97) | 97 (96, 98) | 97 (96, 98) | ||||
CI = Confidence interval; PPV = Positive predictive value; NPV = Negative predictive value.
a
Assumed population prevalence = 9%.38