Dual Algorithm Post Market Clinical Study

HTLV-I Infections Clinical Trial

Official title: Evaluation of the MP Diagnostics HTLV Blot 2.4

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• HTLV I Associated Myelopathies
• HTLV I Associated T Cell Leukemia Lymphoma
• HTLV-I Infections
• HTLV-II Infections
• Human T-lymphotropic Virus 1
• Human T-lymphotropic Virus 2
• Infection
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Spinal Cord Diseases

• NCT number: NCT03146013
• Study type: Observational
• Source: MP Biomedicals, LLC
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Completion date: May 31, 2017