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Zhen Jiang

FDA



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693 – Evaluation of In Vitro Diagnostics

Statistical Considerations in Clinical Studies Supporting Blood Donor Screening Assays

Sponsor: Section on Medical Devices and Diagnostics
Keywords: Donor screening assay, Sensitivity, Specificity

Zhen Jiang

FDA

21 CFR § 610.40 requires using donor screening assays to control transfusion-transmitted infectious diseases. The implementation of donor screening assays along with donor selection has dramatically reduced disease transmissions risk from blood transfusion. In this paper, we will discuss the unique features of donor screening assays (e.g. intended population, technical characteristics) comparing to diagnostic assays. Some of these features lead to the particular study designs we see and several issues in the clinical sensitivity and specificity studies, which we will illustrate and discuss in detail.

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