Dual Algorithm Post Market Clinical Study

Completed

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT03146013

Run by

MP Biomedicals, LLC

People needed

100

Starts

2017-03-01

Expected to finish

2017-05-31

Last updated by the study team

2017-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• American Red Cross - National Testing Laboratory — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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