The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).
This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.
Study Type
OBSERVATIONAL
Enrollment
100
HTLV I/II Confirmation and Differentiation
American Red Cross - National Testing Laboratory
Charlotte, North Carolina, United States
Assess the HTLV dual algorithm testing in blood donor facilities
HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.
Time frame: 3 months
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