Spots Global Cancer Trial Database for Dual Algorithm Post Market Clinical Study
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Trial Identification
Brief Title: Dual Algorithm Post Market Clinical Study
Official Title: Evaluation of the MP Diagnostics HTLV Blot 2.4
Study ID: NCT03146013
Interventions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
American Red Cross - National Testing Laboratory, Charlotte, North Carolina, United States
Contact Details
Name: Susan Stramer, Ph.D
Affiliation: American National Red Cross
Role: PRINCIPAL_INVESTIGATOR
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