TABLE 3.
Method | No. positive | No. equivocal | Sensitivity (%)a | 95% CI (%)a | Sensitivity (%)b | 95% CI (%)b |
---|---|---|---|---|---|---|
Enzygnost | 49 | 2 | 94.2 | 83.1–98.5 | 98.1 | 88.4–99.9 |
Euroimmun | 41 | 6 | 78.8 | 64.9–88.5 | 90.4 | 78.2–96.4 |
Euroimmun Nucleoprotein | 39 | 6 | 75.0d | 60.8–85.5 | 86.5 | 73.6–94.0 |
IBL | 49 | 1 | 94.2 | 83.1–98.5 | 96.2 | 85.7–99.3 |
LIAISON XL | 45 | 0 | 86.5 | 73.6–94.0 | 86.5 | 73.6–94.0 |
Microimmune | 48 | 3 | 92.3 | 80.6–97.5 | 98.1 | 88.4–99.9 |
NovaLisa | 49 | 0 | 94.2 | 83.1–98.5 | 94.2 | 83.1–98.5 |
Serion (activity calculator)c | 51 | 0 | 98.1d | 88.4–99.9 | 98.1 | 88.4–99.9 |
Serion (OD range)c | 51 | 0 | 98.1d | 88.4–99.9 | 98.1 | 88.4–99.9 |
Serion (special case formula)c | 51 | 0 | 98.1d | 88.4–99.9 | 98.1 | 88.4–99.9 |
Specimens with equivocal results counted as negative.
Specimens with equivocal results counted as positive.
Three methods of sample result determination, using the single set of optical density data from the test plates, were provided in the manufacturer’s IFU. All three methods were evaluated.
Significant difference (P < 0.05) between the most sensitive (Serion, all three result determination methods) and the least sensitive methods (Euroimmun NP) based on nonoverlapping 95% confidence intervals. This difference is only significant when equivocal results are counted as negative.