NCT01467024

Evaluation of the MP Diagnostics HTLV Blot 2.4

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: MP Biomedicals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
OTHER	CDPHL Algorithm	Supplemental testing algorithm performed by the CDPHL.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2011-11-08
• Last updated: 2011-11-08

Locations

2 sites across 1 country: United States