On-site in vitro Diagnostic: Real-time Loop-Mediated Isothermal Amplification Detection of HIV-2 Groups A and B


This CDC-developed technology entails a nucleic acid-based HIV-2 in vitro diagnostic assay that is well-suited for use in mobile testing units/vehicles or resource-limited settings, for example, many areas of West Africa. Because HIV-2 requires unique treatment regimens, accurate, early diagnosis is crucial for effective care and directing treatment. Recently, new HIV testing recommendations have been proposed for laboratory settings, which include the use of a HIV-1/HIV-2 discriminatory assay. The use of a discriminatory assay will aid clinicians in the detection of HIV-2 infection; however, current HIV screening tests are antibody-based and frequently yield a false-negative result if a patient is tested during early infection, prior to seroconversion.

In this technology, RT-LAMP (Reverse Transcription-Loop-mediated Isothermal Amplification) provides a rapid, portable, easy to perform assay that can be used for early-stage HIV confirmation, bypassing the risk of false-negative results. The HIV-2 RT-LAMP assay can detect both HIV-2 RNA and DNA in the same reaction, and greatly narrows the window from infection to detection through observation of peak levels of virus replication that are a characteristic of early infection. Further, the assay as developed can also detect sequences from both circulating HIV-2 groups, A and B. This assay brings the potential for viral nucleic acid-based HIV diagnosis to millions of people living in low-resource settings, and may be quite useful for mobilized HIV/AIDS testing and control units operating around the world.

Potential Commercial Applications: Competitive Advantages:
  • HIV/AIDS screening and control programs in low-resource settings
  • Nucleic acid-based, early-stage diagnosis of HIV-2 infection (both groups A and B) in locales where thermocyclers are not available
  • Screening blood donations in emergency transfusion scenarios
 
  • Extraordinary flexibility for testing settings; assay is well-suited for use at the point-of-care or in resource-limited regions
  • Detects both HIV-2 RNA and DNA in the same reaction
  • Easy to perform, and can be incorporated into a portable kit format
  • Can provide rapid on-the-spot diagnosis


Development Stage:
  • In vitro data available
  • In situ data available (on-site)


Related Invention(s):
E-128-2013/0
E-173-2013/0
E-273-2013/0
E-625-2013/0


Inventors:

Sherry Owen (CDC)  ➽ more inventions...

Kelly Curtis (CDC)  ➽ more inventions...

Donna Rudolph (CDC)  ➽ more inventions...

Philip Niedwiedz (CDC)  ➽ more inventions...

Timothy Granade (CDC)  ➽ more inventions...

Ae Saekhou Youngpairoj (CDC)  ➽ more inventions...

Chou-Pong Pau (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 15/120,270
US Application No. 61/943,001
PCT Application No. PCT/US2015/016814

Publications:
Curtis KA, et al. PMID 24789187
Curtis KA, et al. PMID 22384022
Curtis KA, et al. PMID 19382260
Curtis KA, et al. PMID 18524393

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

OTT Reference No: E-020-2014/0
Updated: Jun 2, 2014