CompletedNot Applicable

Dual Algorithm Post Market Clinical Study

United States100 participantsStarted 2017-03-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Assess the HTLV dual algorithm testing in blood donor facilities

Timeframe: 3 months

Trial details

NCT IDNCT03146013

SponsorMP Biomedicals, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-05-31

View on ClinicalTrials.gov More HTLV-I Infections trials