Clinical Trial: Dual Algorithm Post Market Clinical Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Evaluation of the MP Diagnostics HTLV Blot 2.4

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 Summary: 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.
Sponsor: MP Biomedicals, LLC

Current Primary Outcome: Assess the HTLV dual algorithm testing in blood donor facilities [ Time Frame: 3 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: MP Biomedicals, LLC

Dates:
Date Received: May 5, 2017
Date Started: March 1, 2017
Date Completion: June 1, 2017
Last Updated: May 5, 2017
Last Verified: May 2017