Patients Blood Donors Total Subjects Estimated Value 95% Confidence Interval Estimated Value 95% Confidence Interval Estimated Value 95% Confidence Interval Lower Limit Upper Limit Lower Limit Upper Limit Lower Limit Upper Limit Prevalence 25.74 20.4 31.88 2.72 1.52 4.73 10.39 8.3 12.93 Sensitivity 98.36 90.02 99.91 100 71.66 100 98.65 91.68 99.93 Specificity 96.02 91.65 98.25 99.35 97.96 99.83 98.43 97.04 99.2 Positive 28.27 22.72 34.53 3.35 1.99 5.49 11.66 9.44 14.3 Negative 71.73 65.47 77.28 96.65 94.5 98.01 88.34 85.7 90.56 Positive Predictive Value (True Positive) 89.55 79.06 95.34 81.25 53.69 95.03 87.96 78.51 93.76 False Positive 10.45 4.66 20.94 18.75 4.97 46.31 12.05 6.24 21.49 Negative Predictive Value (True Negative) 99.41 96.27 99.97 100 98.97 100 99.84 98.97 99.99 False Negative 0.59 0.03 3.73 0 0 1.03 0.16 0.01 1.03 likelihood Ratios:                 Positive [C] 24.73 11.958 51.146 155 50.174 478.833 62.938 34.01 116.471 Negative [C] 0.017 0.002 0.119 0 0 NaN* 0.014 0.001 0.096 Positive [W] 8.571 4.232 17.361 4.333 1.521 12.344 7.3 4.06 13.126 Negative [W] 0.006 0.0008 0.042 0 0 NaN* 0.002 0.0002 0.011 [C] = conventional [W] = weighted by prevalence *'NaN' in any of the above cells means that the calculation cannot be performed because the values entered include one or more instances of zero.

Table 2: Diagnostic Performance of OptiMAL-IT in patients, blood donors, and total subjects calculated on the basis of confirmed microscopy results.