Dual Algorithm Post Market Clinical Study

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).

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Key information

Conditions

HTLV-I Infections Central Nervous System Diseases Central Nervous System Infections Deltaretrovirus Infections HTLV I Associated Myelopathies HTLV I Associated T Cell Leukemia Lymphoma HTLV-II Infections Hematologic Diseases Hemic and Lymphatic Diseases Human T-lymphotropic Virus 1 Human T-lymphotropic Virus 2 Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoproliferative Disorders Myelitis Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neuroinflammatory Diseases Paraparesis, Tropical Spastic RNA Virus Infections Retroviridae Infections Spinal Cord Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

American Red Cross - National Testing Laboratory

Charlotte, North Carolina, 28273, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MP Diagnostics HTLV Blot 2.4

Diagnostic Test

HTLV I/II Confirmation and Differentiation

Other names: HTLV I/II Western Blot Assay

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

MP Biomedicals, LLC

Industry

Collaborators

MP Biomedicals Asia Pacific Pte. Ltd.

Registry information

Official study title

Evaluation of the MP Diagnostics HTLV Blot 2.4

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 9, 2017
Registry last updated: Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed