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. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y

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© The Author(s) 2021

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Pre-study validation normal healthy (NH) and in-study disease state (DS) screening sample RLU/NC RLU ratios with the means significantly different and variances not significantly different. Applying the validation screening cut point factor (SCPF) of 1.09 results in the in-study false positive rate of 10%. As this is within a 2 to 11% criteria, the validation SCPF can be used for testing the in-study samples. RLU indicates relative light unit. NC indicates negative control