TABLE 5.
Method | Measles specimens with equivocal results counted as negativeb |
All specimens with equivocal results counted as positivec |
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Accuracy (%) | 95% CI (%) | Kappa statistic | 95% CI | Accuracy (%) | 95% CI (%) | Kappa statistic | 95% CI | |
Enzygnost | 95.0 | 91.2–97.3 | 0.858 | 0.781–0.936 | 95.8 | 92.2–97.9 | 0.884 | 0.813–0.954 |
Euroimmun | 92.1 | 87.7–95.0 | 0.762 | 0.660–0.863 | 94.6 | 90.7–96.9 | 0.843 | 0.761–0.926 |
Euroimmun Nucleoprotein | 93.7 | 89.7–96.3 | 0.800 | 0.704–0.897 | 96.2 | 92.7–98.2 | 0.885 | 0.812–0.959 |
IBL | 95.8 | 92.2–97.9 | 0.880 | 0.808–0.953 | 96.2 | 92.7–98.2 | 0.893 | 0.825–0.961 |
LIAISON XL | 96.7e | 93.3–98.4 | 0.897 | 0.828–0.967 | 96.7 | 93.3–98.4 | 0.897 | 0.828–0.967 |
Microimmune | 96.2 | 92.7–98.2 | 0.890 | 0.820–0.960 | 97.5e | 94.4–99.0 | 0.928 | 0.872–0.985 |
NovaLisa | 90.0 | 85.3–93.3 | 0.738 | 0.641–0.835 | 90.0e | 85.3–93.3 | 0.738 | 0.641–0.835 |
Serion (activity calculator)d | 90.8 | 86.2–94.0 | 0.763 | 0.670–0.855 | 90.8e | 86.2–94.0 | 0.763 | 0.670–0.855 |
Serion (OD range)d | 91.2 | 86.7–94.3 | 0.772 | 0.681–0.863 | 91.2e | 86.7–94.3 | 0.772 | 0.681–0.863 |
Serion (special case formula)d | 89.1e | 84.3–92.6 | 0.726 | 0.630–0.822 | 89.1e | 84.3–92.6 | 0.726 | 0.630–0.822 |
Measles samples with equivocal results were counted as both negative and positive. Non-measles samples with equivocal results were always counted as positive.
Specimens in the measles sera panel with equivocal results were counted as negative, and specimens in the non-measles sera panel with equivocal results were counted as positive. In this scenario, equivocal results are considered to be “always wrong.”
All specimens (measles and non-measles) with equivocal results were counted as positive. In this scenario, equivocal results for the measles sera panel were considered correct and incorrect for the non-measles sera panel.
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 accurate and the least accurate method(s) based on nonoverlapping 95% confidence intervals. When equivocal results were considered to be “always wrong,” the most accurate method, LIAISON XL, was significantly (P < 0.05) better than the Serion kit using the special case formula result determination method. When equivocal results were counted as positive, the most accurate method, Microimmune, was significantly (P < 0.05) better than NovaLisa and Serion (all three result determination methods).