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.
Observational Model: Cohort, Time Perspective: Retrospective
Susan Stramer, Ph.D
American Red Cross
United States: Food and Drug Administration
|California Department of Public Health||Richmond, California 94804|
|LABS, Inc||St. Louis, Missouri 38611|