Dual Algorithm Post Market Clinical Study

HTLV-I Infections Clinical Trial

Official title:

Evaluation of the MP Diagnostics HTLV Blot 2.4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146013
• Other study ID #: MP EIA-HTLV-001B Amendment 6.0
• Status: Completed
• Phase: N/A
• First received: May 5, 2017
• Last updated: June 9, 2017
• Start date: March 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2017
• Source: MP Biomedicals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HTLV I Associated Myelopathies
• HTLV I Associated T Cell Leukemia Lymphoma
• HTLV-I Infections
• HTLV-II Infections
• Human T-lymphotropic Virus 1
• Human T-lymphotropic Virus 2
• Infection
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Spinal Cord Diseases

Intervention

Diagnostic Test:
• MP Diagnostics HTLV Blot 2.4
HTLV I/II Confirmation and Differentiation

Locations

Country	Name	City	State
United States	American Red Cross - National Testing Laboratory	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
MP Biomedicals, LLC	MP Biomedicals Asia Pacific Pte. Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller 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. Review. — View Citation

Outcome

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