Technology ID

Monoclonal Antibody to Detect the Antiretroviral Drug Emtricitabine – for HIV Drug Adherence Monitoring

Lead Inventor
Granade, Timothy (CDC)
Youngpairoj, Ae Saekhou (CDC)
Switzer, William (CDC)
Heneine, Walid (CDC)
Pau, Chou-Pong (CDC)
Zheng, HaoQiang (CDC)
Pohl, Jan (CDC)
Research Materials
Occupational Safety and Health
Consumer Products
Therapeutic Areas
Infectious Disease
Development Stages
Research Products
Lead IC
The U.S. Food and Drug Administration and World Health Organization (WHO) approved the antiretroviral drug emtricitabine (FTC)/ tenofovir disoproxil fumurate (TDF) combination for HIV pre-exposure prophylaxis (PrEP) in high risk populations. Efficacy of PrEP depends strongly on adherence to taking the FTC/TDF pill daily. In the US, the Centers for Disease Control and Prevention (CDC) estimates that 1.2 million Americans will benefit from PrEP. FTC is also a key component of antiretroviral therapy (ART) regimens of HIV-infected persons and significantly associated with adherence. According to reports from the WHO, 21.7 million HIV-infected persons worldwide were receiving ART by the end of 2017. Currently, laboratories use costly, complex, and time- consuming mass-spectrometry blood tests to monitor compliance in patients receiving PrEP and ART treatment.

CDC recently developed a monoclonal antibody (mAb) that specifically reacts with FTC. An enzyme immunoassay (EIA) test developed from the mAb could potentially maximize efficacy in PrEP users. The competitive EIA has clinically relevant sensitivity and specificity to FTC in urine. The mAb is also able to detect FTC in a lateral flow assay. These FTC assays may also aid ART management in HIV-infected persons to optimize treatment efficacy and maximize viral suppression.
Commercial Applications
  • Development of plate-based enzyme immunoassays (EIAs) for a manufactured diagnostic kit and lateral flow assays for Point-of-care (POC) rapid diagnostics for antiretroviral drug emtricitabine (FTC) treatment adherence
  • Testing to monitor at-risk populations for HIV on PrEP
  • Testing to monitor HIV-infected populations on ART
  • Testing in surveillance programs and clinical research (e.g., clinical trials)
  • Use of assays and monoclonal antibody in laboratory research, in vitro and in vivo (e.g., animal models)
Competitive Advantages
  • The mAb has high sensitivity and specificity to FTC – does not react with naturally occurring similar molecules in humans
  • Does not require costly mass spectrometry equipment and complex processing
  • The technology can be used by a variety of healthcare providers
  • Rapid results vs. a few weeks for standard lab results
  • No need for blood collection or finger stick by healthcare workers – reducing risk of HIV exposure
  • Pain-free, non-invasive testing of urine specimens
Licensing Contact:
Mitzelfelt, Jeremiah