Technology Bundle ID
TAB-3251

Real-Time RT-PCR Detection of Rickettsia species -- PanR6/Total Nucleic Acid Assay with High Sensitivity and Specificity

Linked ID
E-230-2017-0
Lead Inventors
Cecilia Kato (CDC)
Co-Inventors
Ida Chung (CDC)
Development Stages
Pre-clinical (in vivo)
ICs
CDC
Rickettsial infections are caused by bacteria from the Rickettsia genus which are often spread by biting ticks, fleas, mites or lice. Rickettsia can cause mild to severe illness and Rickettsia species can be found worldwide. Early stage, nonspecific symptoms of infections can make clinical diagnosis difficult. Rickettsial infection symptoms, if present, typically develop within 1 -2 weeks of exposure and include fever, headache, malaise, rash, nausea, and vomiting. Some rickettsial diseases such as Rocky Mountain spotted fever (RMSF), Mediterranean spotted fever, and typhus fever, can be life threatening and even fatal in 20% - 60% of untreated cases. Prompt identification of rickettsioses and treatment are essential. No vaccine is available for preventing rickettsial infections.

CDC scientists have developed a Pan-Rickettsia genus (PanR6) real-time reverse transcriptase PCR (real-time RT PCR) assay targeting both rRNA and rDNA in total nucleic acid (TNA). With high specificity, PanR6 detects 16 Rickettsia species and excludes 15 near neighbors (similar species). Increased sensitivity and accuracy of Rickettsia genus real-time RT PCR detection in clinical samples provides an important step towards early and more effective diagnosis of rickettsial infections. In patient sample testing, the sensitivity of the new PanR6/TNA assay increases diagnostic accuracy by increasing detection sensitivity 100 to 1000 times over current molecular DNA, southern blot, and serological tests which depend upon the specimen collected. A mock clinical specimen panel is being assembled for additional PanR6/TNA assay precision and accuracy validation.

Commercial Applications
  • Human and animal diagnosis of rickettsial infections
  • Real-time RT PCR kit
  • Potential for development into point-of-care diagnostic assay
  • Can be used for outbreak testing and cases of unknown febrile illnesses
  • Quality assurance/quality control (QA/QC) testing for vaccine candidate development
  • Licensee may potentially distribute assay to CDC laboratory response network (LRN) partners
Competitive Advantages
  • High sensitivity and specificity for Rickettsia
  • Enables early, acute stage diagnosis not previously possible
  • Initial data shows new PanR6/TNA assay offers 100 to 1000 times greater detection v. standard assays

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