Dual Algorithm Post Market Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-05-31

Brief Summary

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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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Detailed Description

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HTLV Repeat Reactive (RR) / Non Reactive (NR)

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

MP Diagnostics HTLV Blot 2.4

Intervention Type DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Interventions

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MP Diagnostics HTLV Blot 2.4

HTLV I/II Confirmation and Differentiation

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HTLV I/II Western Blot Assay

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No