Clinical trial · Observational
Dual Algorithm Post Market Clinical Study
Evaluation of the MP Diagnostics HTLV Blot 2.4
NCT03146013CI-TRIAL-00028084completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HTLV I Associated Myelopathies | — | UNRESOLVED | — |
| HTLV I Associated T Cell Leukemia Lymphoma | Adult T-Cell Leukemia/Lymphoma | ALIAS | 0.90 |
| HTLV-II Infections | — | UNRESOLVED | — |
| HTLV-I Infections | — | UNRESOLVED | — |
| Human T-lymphotropic Virus 1 | — | UNRESOLVED | — |
| Human T-lymphotropic Virus 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MP Diagnostics HTLV Blot 2.4 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HTLV Repeat Reactive (RR) / Non Reactive (NR)
- description
- 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
- interventionNames
- Diagnostic Test: MP Diagnostics HTLV Blot 2.4
Primary outcomes (1)
- measure
- Assess the HTLV dual algorithm testing in blood donor facilities
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMiller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11. PMID 26589659