It is important to recognize that all COVID-19 tests approved through the EUA process were validated in relatively small patient populations when compared to traditional testing standards. Current EUA approval requires all antibody tests to accurately identify at least 90% of positive cases (sensitivity) and 95% of negative cases (specificity). Estimates of sensitivity and specificity are just that, estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test's sensitivity and specificity will fall within, given how many samples were used in the performance validation. The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

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