TABLE 5.
Performance of the AmnioQuick Duo+and PAMG-1 tests for diagnosis of prolonged PROM by gestational age at presentation.
| Performance evaluator | AmnioQuick Duo+ | PAMG-1 |
|---|---|---|
| Gestational age <34 wk | ||
| No. of true negatives | 11 | 11 |
| No. of true positives | 31 | 28 |
| No. of false negatives | 1 | 4 |
| No. of false positives | 0 | 0 |
| Total no. | 43 | 43 |
| Specificity, % (95% CI) | 100 (67.9–100) | 100 (67.9–100) |
| Sensitivity, % (95% CI) | 96.9 (82.0–99.8) | 87.5 (70.1–95.9) |
| NPV, % (95% CI) | 91.7 (59.8–99.6) | 73.3 (44.8–91.1) |
| PPV, % (95% CI) | 100 (86.3–100) | 100 (85.0–100) |
| Accuracy, % (95% CI)a | 97.7 (82.5–99.9) | 90.7 (72.8–97.9) |
| Gestational age ≥34 wk | ||
| No. of true negatives | 13 | 13 |
| No. of true positives | 42 | 42 |
| No. of false negatives | 1 | 1 |
| No. of false positives | 0 | 0 |
| Total no. | 56 | 56 |
| Specificity, % (95% CI) | 100 (71.7–100) | 100 (71.7–100) |
| Sensitivity, % (95% CI) | 97.7 (86.2–99.9) | 96.6 (86.2–99.9) |
| NPV, % (95% CI) | 92.9 (64.2–99.6) | 92.9 (64.2–99.6) |
| PPV, % (95% CI) | 100 (89.6–100) | 100 (89.6–100) |
| Accuracy, % (95% CI)b | 98.2 (88.4–99.9) | 98.2 (88.4–99.9) |
Abbreviations: CI, confidence interval; NPV, negative predictive value; PAMG-1, placental α-microglobulin-1; PPV, positive predictive value; PROM, premature rupture of membranes.
a
Among women presenting with prolonged PROM <34 wk, the AmnioQuick Duo+ accuracy of 97.7% was not statistically different to the PAMG-1 test accuracy of 90.7% (Pearson χ2=0.180, P=0.360; relative risk 2.59, 95% CI 0.40–217.09).
b
Similarly, among women presenting with PROM at ≥34 wk, the AmnioQuick Duo+ accuracy of 98.2% was not statistically different to the PAMG-1 test accuracy of 98.2% (Pearson χ2=0.712, P>0.99; relative risk 1.00, 95% CI 0.25–4.05).