Simple and Rapid Assay to Detect Acute Subtype B and Group M HIV-1 Infections

Within recent years, point-of-care (POC) testing has allowed for many individuals to be screened for and provided with HIV test results. It is critical to be able to accurately detect acute HIV infections as this is a stage where the risk of transmission is great. Additionally, early HIV detection could lead to less high-risk behavior, thereby reducing transmission. Currently, there are no rapid, cost-effective diagnostic tests sensitive enough to detect acute HIV-1 infections for the POC setting.

Researchers at the CDC have developed an HIV-1 detection assay using reverse-transcription loop-mediated isothermal amplification (RT-LAMP) that is quick, easy to perform, and does not require complex, dedicated equipment or laboratory space. These features are ideal for POC and could increase the percentage of individuals who receive their HIV status, while immediately linking them to counseling and medical care. Also, the early knowledge of their HIV status could lead to reduced high-risk behavior at a time when individuals exhibit a greater risk for transmitting the virus.

Potential Commercial Applications: Competitive Advantages:
  • Diagnosis of acute HIV-1 infection.
  • Diagnosis of infants from HIV-1 infected mothers.
  • Test methods are ideal for use in POC or resource-limited settings.
  • Rapid, easy to perform, cost-effective and can be portable - ideal for POC.
  • Sample versatility: isolated DNA/RNA, blood, urine, saliva, tissue biopsy, fine needle aspirate, surgical specimen.
  • Detection of HIV-1 RNA/DNA in the same reaction.
  • Primers designed based on highly conserved regions within the HIV-1 integrase gene for detection of subtype B infections and of all group M isolates.

Related Invention(s):


Sherry Owen (CDC)  ➽ more inventions...

Kelly Curtis (CDC)  ➽ more inventions...

Donna Rudolph (CDC)  ➽ more inventions...

Philip Niedzwiedz (CDC)  ➽ more inventions...

Intellectual Property:
US Application No. 62/076,334
PCT Application No. PCT/US2015/057861
US Application No. 15/524,209

Curtis KA, et al. PMID 22384022

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

OTT Reference No: E-014-2015/0
Updated: Mar 15, 2017