Real-Time PCR Assay for HIV-1 Subtype Diagnosis and Global Surveillance of Drug Resistance

CDC researchers have developed a patented set of RT-PCR and sequencing primers based on HIV-1 group M sequences. Evaluation of the primers using samples collected around the world demonstrated broad detection capacity for multiple HIV-1 group subtypes and predominant circulating recombinant forms. Commercially available HIV-1 drug resistance (HIVDR) genotyping assays are expensive and have limited ability to detect non-B subtypes. This optimized assay is broadly sensitive in genotyping HIV-1 group M viral strains and more sensitive than other assays in detecting mixed viral populations. This technology can be used in resource-limited settings where HIVDR surveillance is recommended to minimize the development and transmission of HIVDR.

  • Utility for HIV-1 sub-typing detection, evaluation of anti-HIV therapeutic efficacy, and HIV drug resistance (HIVDR) surveillance and monitoring
  • Rapid, accurate, and cost-effective technology easily adapted as a kit

  • Potential Commercial Applications: Competitive Advantages:
    • HIV-1 sub-typing diagnostic
    • Evaluation of efficacy of anti-HIV therapeutics
    • HIV drug resistance (HIVDR) surveillance and monitoring
    • Cost-effective
    • Simple to implement
    • Rapid, accurate and objectively conclusive
    • Easily implemented as a kit
    • Assay could be applicable to HIVDR genotyping in both ART-naive and ART-experienced populations


    Chunfu Yang (CDC)  ➽ more inventions...

    Nicholas Wagar (CDC)  ➽ more inventions...

    Joshua Devos (CDC)  ➽ more inventions...

    Zhiyong Zhou (CDC)  ➽ more inventions...

    Intellectual Property:
    U.S. Pat: 10,053,741 issued 2018-08-21
    U.S. Pat: 9,040,244 issued 2015-05-26
    PCT Application No. PCT/US2012/045523
    US Application No. 61/504,522

    Zhou Z, et. al. PMID 22132237
    Yang C, et al. PMID 20660209

    Collaboration Opportunity:

    The Centers for Disease Control and Prevention (CDC) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Real-time PCR Assay for HIV-1 Subtype Diagnosis and Global Surveillance of Drug Resistance. For collaboration opportunities, please contact CDC TTO at or 1-404-639-1330.

    Licensing Contact:
    Jeremiah Mitzelfelt,
    Phone: 301-443-8518

    OTT Reference No: E-259-2013-0
    Updated: Sep 16, 2019