Spots Global Cancer Trial Database for Evaluation of the MP Diagnostics HTLV Blot 2.4

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Evaluation of the MP Diagnostics HTLV Blot 2.4

Official Title: Evaluation of the MP Diagnostics HTLV Blot 2.4

Study ID: NCT01467024

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

Interventions

CDPHL Algorithm

Study Description

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.