Evaluation of the MP Diagnostics HTLV Blot 2.4 - Full Text View

Purpose

The purpose of this study is:

To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.

Condition	Intervention
HTLV-I Infections HTLV-II Infections Human T-lymphotropic Virus 1 Human T-lymphotropic Virus 2 HTLV I Associated T Cell Leukemia Lymphoma HTLV I Associated Myelopathies	Other: CDPHL Algorithm


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Evaluation of the MP Diagnostics HTLV Blot 2.4

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Human T-cell Leukemia Virus Type 1 Human T-cell Leukemia Virus Type 2 Myelitis

U.S. FDA Resources

Further study details as provided by MP Biomedicals, LLC:


Estimated Enrollment:	600
Study Start Date:	November 2011
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
EIA Negative Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.	Other: CDPHL Algorithm Supplemental testing algorithm performed by the CDPHL.
EIA Repeat Reactive Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.	Other: CDPHL Algorithm Supplemental testing algorithm performed by the CDPHL.
Known Positive Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.	Other: CDPHL Algorithm Supplemental testing algorithm performed by the CDPHL.

Detailed Description:

This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at three geographical distinct locations.

The validity of the MP Blot will be assessed by calculating the following:

Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens

The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.

The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All populations are from whole blood donors.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467024

Locations


United States, California
California Department of Public Health
Richmond, California, United States, 94804
United States, Missouri
LABS, Inc
St. Louis, Missouri, United States, 38611

Sponsors and Collaborators

MP Biomedicals, LLC

Vital Systems Inc.

Investigators


Principal Investigator:	Susan Stramer, Ph.D	American National Red Cross

More Information


Responsible Party:	MP Biomedicals, LLC
ClinicalTrials.gov Identifier:	NCT01467024 History of Changes
Other Study ID Numbers:	MP-EIA-HTLV-001B
Study First Received:	October 31, 2011
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by MP Biomedicals, LLC:


HTLV Confirmatory Supplemental	Blot HTLV-I HTLV-II

Additional relevant MeSH terms:


Paraparesis, Tropical Spastic Infection Communicable Diseases Leukemia, T-Cell Spinal Cord Diseases HTLV-I Infections Leukemia-Lymphoma, Adult T-Cell HTLV-II Infections Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders	Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Central Nervous System Diseases Nervous System Diseases Deltaretrovirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Myelitis Central Nervous System Infections Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 30, 2016