HTLV-I Infections Clinical Trial
Official title:
Evaluation of the MP Diagnostics HTLV Blot 2.4
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.
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.
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