Novel One-Well Limiting-Antigen Avidity Enzyme Immunoassay to Detect Recent HIV-1 Infection Using a Multi-subtype Recombinant Protein


This CDC developed Limiting-Antigen avidity Enzyme Immunoassay (LAg-avidity-EIA) provides an easy way to measure increasing binding strength (avidity) of HIV antibodies as part of maturation HIV antibodies after seroconversion, providing a method to distinguish early-stage from long-term HIV-1 infection. Surveillance of HIV-1 provides information on prevalence rates of the disease, but determination of new infection rates (HIV-1 incidence) is difficult to deduce. Longitudinal follow up is expensive and can be biased.

Unlike assays which use antigens derived from only one subtype and use two wells, this new approach employs a multi-subtype recombinant protein, rIDR-M, to permit equivalent detection of antibody avidity among different subtypes, and measures binding strength of antibody in one well. This assay will allow the simultaneous testing of more specimens and better overall reproducibility due to its design. Further, the approach is likely to be more robust and provide more accurate results. The assay may be used for individual diagnosis of recent or long-term infection, but may also act as an important tool for worldwide HIV-1 surveillance, assessing new trends of infections, and monitoring success of varied and comparable prevention efforts implemented by major public health agencies.

Potential Commercial Applications: Competitive Advantages:
  • Population surveillance: estimation of HIV-1 incidence in cross-sectional specimens
  • Identifying recent infection risk factors
  • Following antibody avidity maturation over time
 
  • Assay permits equivalent detection of HIV antibody avidity among different subtypes
  • Design of LAg avidity-EIA allows for testing more samples and better reproducibility when compared to two-well avidity index EIA


Development Stage:
In vitro data available

Inventors:


Intellectual Property:
Research Tool – Patent protection is not being pursued for this technology.

Publications:
Duong YT, et al. PMID 22479384
Wei X, et al. [PMID 20063992

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a system to monitor water supplies for a variety of pathogens. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 1-404-639-1330.


Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-522-2013-0
Updated: Jul 9, 2020