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. 2017 Feb 1;15(1):70–80. doi: 10.1089/hs.2016.0043

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© Richard M. Ozanich et al., 2017; Published by Mary Ann Liebert, Inc.

This Open Access article is distributed under the terms of the Creative Commons Attribution Noncommercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

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Figure 1. — Number of independent tests required to meet the performance criterion of 0.95 LCB and 95% confidence at the sample test concentration. If the number of failed results is 0 out of 47 tested samples, 1 out of 79 samples, or 2 out of 107 samples, then a device meets the lower confidence bound of the probability of detection of 0.95 (indicated as the horizontal line) at the sample concentration with 95% confidence. The vertical lines matching the curves bound the regions, in number of samples tested, where the lower confidence bound for a 1-sided 95% confidence interval is equal to 0.95 to 2 decimal places for the cases where 0, 1, or 2 failed tests are observed. For example, the 2 dashed vertical lines indicate that a lower confidence bound estimate of 0.95 (to 2 decimal places) will be observed with 0 failed tests and between 47 and 57 samples tested.