Setting Bias Specifications Based on Qualitative Assays With a Quantitative Cutoff Using COVID-19 as a Disease Model

Abstract Objectives Automated qualitative serology assays often measure quantitative signals that are compared against a manufacturer-defined cutoff for qualitative (positive/negative) interpretation. The current general practice of assessing serology assay performance by overall concordance in a qu...

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Veröffentlicht in:American journal of clinical pathology 2022-10, Vol.158 (4), p.480-487
Hauptverfasser: Lim, Chun Yee, Chang, Wei Zhi, Markus, Corey, Horvath, Andrea Rita, Loh, Tze Ping
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Sprache:eng
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