Technology ID
TAB-4621

HIV-2 Plasmid DNA Library for Diagnostic Assay Development

E-Numbers
E-025-2014-0
Lead Inventor
Youngpairoj, Ae Saekhou
Lead IC
CDC
Co-Inventors
Curtis, Kelly
Pau, Chou-Pong
Owen, Sherry
Granade, Timothy
ICs
CDC
Applications
Diagnostics
Therapeutic Areas
Infectious Disease
Development Stages
Pre-Clinical (in vitro)
Research Products
Plasmids/Vectors

This technology includes a HIV-2 plasmid library for use in diagnostic assay development. In December of 2012, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) proposed a new US laboratory testing algorithm for the diagnosis of HIV infections. This new algorithm recommends additional testing for confirmation of HIV infection using a nucleic acid amplification test (NAAT) in the event of discordant serological test results. This invention is significant because there are few HIV-2 specimens available for use in assay development and optimization. Additionally, there is limited availability of material for use as assay controls and for the monitoring of laboratory quality and operator proficiency.

Commercial Applications
The plasmid library described here would be useful for HIV-2 diagnostic assay development and for quality control or proficiency testing reagents in existing or new diagnostic assays.

Competitive Advantages
At present, there is no FDA-approved NAAT for the diagnosis of HIV-2 infections, and, due to the low prevalence of HIV-2 in the US, HIV-2 specimens are not readily available for optimization and validation of new procedures or technologies.
Licensing Contact:
Motley, Jonathan
jonathan.motley@nih.gov