Author: Andrew C Nelson; Benjamin Auch; Matthew Schomaker; Daryl M Gohl; Patrick Grady; Darrell Johnson; Robyn Kincaid; Kylene E Karnuth; Jerry Daniel; Jessica K Fiege; Elizabeth J Fay; Tyler Bold; Ryan A Langlois; Kenneth B Beckman; Sophia Yohe
Title: Analytical Validation of a COVID-19 qRT-PCR Detection Assay Using a 384-well Format and Three Extraction Methods Document date: 2020_4_5
ID: ec3egn8o_24
Snippet: To calculate the confidence interval for the analytic accuracy of the assay, we counted every unique extraction of a clinical sample or of a synthetic positive extraction control once. We also counted each biologically unique nucleic acid source once. Based on this accounting, we had 47 true positive and 33 true negative results (Table 7) , yielding 100% analytical sensitivity (95% CI: 0.9244-1) and 100% analytical specificity (95% CI: 0.8957-1)......
Document: To calculate the confidence interval for the analytic accuracy of the assay, we counted every unique extraction of a clinical sample or of a synthetic positive extraction control once. We also counted each biologically unique nucleic acid source once. Based on this accounting, we had 47 true positive and 33 true negative results (Table 7) , yielding 100% analytical sensitivity (95% CI: 0.9244-1) and 100% analytical specificity (95% CI: 0.8957-1).
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