Dual Algorithm Post Market Clinical Study

MP Biomedicals

Status: Completed

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

Treatments: Diagnostic Test: MP Diagnostics HTLV Blot 2.4

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03146013

MP EIA-HTLV-001B Amendment 6.0

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

100 participants in 1 patient group

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

Treatment:

Diagnostic Test: MP Diagnostics HTLV Blot 2.4