Evaluation of the MP Diagnostics HTLV Blot 2.4
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01467024 |
Recruitment Status
: Unknown
Verified November 2011 by MP Biomedicals, LLC.
Recruitment status was: Enrolling by invitation
First Posted
: November 8, 2011
Last Update Posted
: November 8, 2011
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment |
---|---|
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 |
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.
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Evaluation of the MP Diagnostics HTLV Blot 2.4 |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | January 2012 |
Estimated Study Completion Date : | June 2012 |

Group/Cohort | Intervention/treatment |
---|---|
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.
|

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
-
EIA Negative Population
- Male or female
- Completion of a health history evaluation for routine donor screening
- Willing and able to provide informed consent
- Negative screening assay results for all ARC screening assays
-
EIA Repeat Reactive Population
- Male or female
- Completion of a health history evaluation for routine donor screening
- Willing and able to provide informed consent
- Previous RR result by bioMerieux ELISA, Abbott EIA, and / or Abbott ChLIA PRISM
-
Known Positive Population
- Male or female
- Willing and able to provide informed consent
- 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
- Inadequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive screening result for any infectious disease tested by ARC
-
EIA Repeat Reactive Population
- Inadequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive result for HIV, HBV, HCV, or any other infectious disease
-
Known Positive Population
- Unwilling or unable to provide informed consent
- Unable to provide adequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive result for HIV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467024
United States, California | |
California Department of Public Health | |
Richmond, California, United States, 94804 | |
United States, Missouri | |
LABS, Inc | |
St. Louis, Missouri, United States, 38611 |
Principal Investigator: | Susan Stramer, Ph.D | American National Red Cross |
Responsible Party: | MP Biomedicals, LLC |
ClinicalTrials.gov Identifier: | NCT01467024 History of Changes |
Other Study ID Numbers: |
MP-EIA-HTLV-001B |
First Posted: | November 8, 2011 Key Record Dates |
Last Update Posted: | November 8, 2011 |
Last Verified: | November 2011 |
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 |