Clinical trial NCT01467024: Evaluation of the MP Diagnostics HTLV Blot 2.4
Official title: Evaluation of the MP Diagnostics HTLV Blot 2.4
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: HTLV
Confirmatory
Supplemental
Blot
HTLV-I
HTLV-II
Lead sponsor: MP Biomedicals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Vital Systems Inc.
First posted: 2011-11-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All populations are from whole blood donors.

Brief summary: The purpose of this study is:

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

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:

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: California Department of Public Health
state: California
city: St. Louis
country: United States
facility: LABS, Inc
state: Missouri
Study officials:
affiliation: American National Red Cross
name: Susan Stramer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: