NCT03146013

Dual Algorithm Post Market Clinical Study

Evaluation of the MP Diagnostics HTLV Blot 2.4

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: MP Biomedicals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HTLV-I Infections
• HTLV-II Infections
• Human T-lymphotropic Virus 1
• Human T-lymphotropic Virus 2
• HTLV I Associated T Cell Leukemia Lymphoma
• HTLV I Associated Myelopathies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MP Diagnostics HTLV Blot 2.4	HTLV I/II Confirmation and Differentiation

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2017-05-09
• Last updated: 2017-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study