Clinical trial · Observational
Evaluation of the MP Diagnostics HTLV Blot 2.4
NCT01467024CI-TRIAL-00005748unknownClinicalTrials.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: 1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4. 2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.
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 |
|---|---|---|---|
| CDPHL Algorithm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- EIA Negative
- description
- Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.
- interventionNames
- Other: CDPHL Algorithm
- label
- EIA Repeat Reactive
- description
- Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.
- interventionNames
- Other: CDPHL Algorithm
- label
- Known Positive
- description
- Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.
- interventionNames
- Other: CDPHL Algorithm
Primary outcomes (0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * EIA Negative Population 1. Male or female 2. Completion of a health history evaluation for routine donor screening 3. Willing and able to provide informed consent 4. Negative screening assay results for all ARC screening assays * EIA Repeat Reactive Population 1. Male or female 2. Completion of a health history evaluation for routine donor screening 3. Willing and able to provide informed consent 4. Previous RR result by bioMerieux ELISA, Abbott EIA, and / or Abbott ChLIA PRISM * Known Positive Population 1. Male or female 2. Willing and able to provide informed consent 3. Previous reactive screening test using either the bioMerieux ELISA, the Abbott EIA or the Abbott ChLIA PRISM, followed by supplemental testing Exclusion Criteria: * EIA Negative Population 1. Inadequate sample volume for testing 2. Unable to provide samples that meet the sample suitability requirements for testing 3. Positive screening result for any infectious disease tested by ARC * EIA Repeat Reactive Population 1. Inadequate sample volume for testing 2. Unable to provide samples that meet the sample suitability requirements for testing 3. Positive result for HIV, HBV, HCV, or any other infectious disease * Known Positive Population 1. Unwilling or unable to provide informed consent 2. Unable to provide adequate sample volume for testing 3. Unable to provide samples that meet the sample suitability requirements for testing 4. Positive result for HIV
References
Publications (0)
Data not yet available
No reference posted for this study.