Dual Algorithm Post Market Clinical Study

Completed

• Conditions: Human T-lymphotropic Virus 2; Human T-lymphotropic Virus 1; HTLV I Associated T Cell Leukemia Lymphoma; HTLV-I Infections; HTLV-II Infections; HTLV I Associated Myelopathies
• Interventions: Diagnostic Test: MP Diagnostics HTLV Blot 2.4

• Registration Number: NCT03146013
• Lead Sponsor: MP Biomedicals, LLC

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female
2. Completion of a health history evaluation for routine donor screening
3. Provided a routine blood donation
4. Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay

Exclusion Criteria

1. Unwilling or unable to provide informed consent to blood donation
2. Inadequate sample volume for testing
3. Unable to provide samples that meet the suitability requirements for testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HTLV Repeat Reactive (RR) / Non Reactive (NR)	MP Diagnostics HTLV Blot 2.4	Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay

Primary Outcome Measures

Name	Time	Method
Assess the HTLV dual algorithm testing in blood donor facilities	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.

Trial Locations

Locations (1)

American Red Cross - National Testing Laboratory; 🇺🇸 Charlotte, North Carolina, United States