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Evaluation of the MP Diagnostics HTLV Blot 2.4


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
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

Thank you

Trial Information

Evaluation of the MP Diagnostics HTLV Blot 2.4


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:

1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens

2. 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Susan Stramer, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

American Red Cross

Authority:

United States: Food and Drug Administration

Study ID:

MP-EIA-HTLV-001B

NCT ID:

NCT01467024

Start Date:

November 2011

Completion Date:

June 2012

Related Keywords:

  • 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
  • HTLV
  • Confirmatory
  • Supplemental
  • Blot
  • HTLV-I
  • HTLV-II
  • Bone Marrow Diseases
  • Spinal Cord Diseases
  • HTLV-I Infections
  • HTLV-II Infections
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Paraparesis, Tropical Spastic
  • Virus Diseases

Name

Location

California Department of Public HealthRichmond, California  94804
LABS, IncSt. Louis, Missouri  38611