Real-Time RT-PCR Detection of Scrub Typhus Total Nucleic Acid Assay with High Sensitivity and Specificity


Scrub typhus is a bacterial disease caused by Orientia tsutsugamushi (O. tsutsugamushi or Ots) that is spread to people through bites of infected chiggers (larval mites). The most common symptoms can include fever, headache, body aches, and sometimes rash. Severe illness can lead to organ failure and bleeding which can be fatal if left untreated. Most cases of scrub typhus occur in Asia Pacific countries, however, recent reports document establishment in the Arabian Peninsula, Chile, and possibly Kenya. Anyone living in or traveling to areas where scrub typhus is found could get infected if they come in contact with infected mites. Currently available DNA molecular tests lack sensitivity to reproducibly detect the low level of scrub typhus bacteria circulating in blood.

CDC scientists developed a real-time reverse transcriptase PCR (real-time RT PCR) assay targeting both ribosomal RNA (rRNA) and ribosomal DNA (rDNA) in total nucleic acid (TNA) to detect Ots. Analytical specificity was tested with 17 Ots strains for inclusivity, and exclusivity with 7 near neighbors and 9 background clinical and environmental Ots DNAs. Initial tests on patient samples show high specificity and sensitivity. CDC’s assay improves diagnostic accuracy by increasing Ots detection sensitivity 10 to 100 times over current molecular DNA tests. CDC technology uses uncomplicated steps so that early acute stage diagnosis of scrub typhus now becomes feasible.

Potential Commercial Applications: Competitive Advantages:
  • Real-time RT PCR kits for scrub typhus infections
  • Potential development into point-of-care diagnostic assays
  • Quality assurance/quality control (QA/QC) testing for vaccine candidate development
  • Licensee may potentially distribute assay technology to CDC laboratory response network (LRN) partners
  • Technology may be used in human and veterinary tick-borne disease differential testing (as tick-borne illnesses and scrub typhus may present with similar symptoms)
  • Public health monitoring and surveillance
 
  • Requires uncomplicated steps and enables early, acute stage diagnosis not previously possible
  • Initial data shows new scrub typhus assay offers 10 to 100 times greater detection sensitivity v. standard PCR assays
  • CDC’s scrub typhus assay has high specificity to 17 Ots strains tested for inclusivity


Related Invention(s):



Inventors:

Cecilia Kato (CDC)  ➽ more inventions...

Ida Chung (CDC)  ➽ more inventions...


Intellectual Property:
PCT Application No. PCT/US2019/018039

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize: Real-Time RT-PCR Detection of Scrub Typhus Total Nucleic Acid Assay with High Sensitivity and Specificity. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 1-404-639-1330.


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

OTT Reference No: E-230-2017-1
Updated: Apr 8, 2019