Dual Algorithm Post Market Clinical Study

Evaluation of the MP Diagnostics HTLV Blot 2.4

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03146013

Enrollment

100

Registered

2017-05-09

Start date

2017-03-01

Completion date

2017-05-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, HTLV-II Infections, HTLV-I Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2

Keywords

HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II

Brief 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).

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMP Diagnostics HTLV Blot 2.4

HTLV I/II Confirmation and Differentiation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assess the HTLV dual algorithm testing in blood donor facilities	3 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026