Rapid Detection of Multi-Drug-Resistant Mycobacterium tuberculosis Using Real-Time PCR and High-Resolution Melt Analysis

CDC scientists have developed a rapid, sensitive, and specific real-time PCR assay that is capable of detecting the presence of Mycobacterium tuberculosis and determining its resistance profile to antibiotics, such as rifampicin and isoniazid. Currently, there are few assays available that are capable of both detecting M. tuberculosis and determining the bacteria's drug resistance. This assay incorporates multiple fluorescent chemistries, providing a simple and cost-effective method of determining the bacteria's drug resistance. Additionally, this assay may be used to quickly discriminate Mycobacterium tuberculosis complex (MTBC) strains from non-MTBC strains.

Potential Commercial Applications: Competitive Advantages:
  • Rapid screening of potential multi-drug-resistant M. tuberculosis
  • Kits for diagnosis of M. tuberculosis
  • Public health programs combating emerging drug-resistance in M. tuberculosis; clinics working with at-risk populations
  • Robust and inexpensive way to detect dominant M. tuberculosis mutations
  • Rapid results within 5 hours of obtaining DNA
  • More cost-efficient and less complex than culturing and sequencing methods of determining drug-resistant status

Development Stage:
  • Early-stage
  • In vitro data available


James Posey (CDC)  ➽ more inventions...

Jonas Winchell (CDC)  ➽ more inventions...

Kelley Cowart (CDC)  ➽ more inventions...

Melissa Ramirez (CDC)  ➽ more inventions...

Intellectual Property:
PCT Application No. PCT/US2011/035217
US Application No. 61/331,189
US Application No. 13/695,935
US Application No. 14/703,019

Ramirez MV, et al. PMID 20810777

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

OTT Reference No: E-160-2013-0
Updated: Dec 5, 2013