Simple and Rapid Loop-Mediated Isothermal Amplification (LAMP)-based Assay for Mycoplasma pneumoniae Detection

Mycoplasma pneumoniae (M. pneumonia) can cause several different types of infection including chest colds and pneumonia. M. pneumoniae is a leading cause of community-acquired pneumonia. People of all ages are at risk for getting M. pneumonia infection, but it is most common among young adults and school-aged children. Current methods of detecting this agent are laborious and time consuming, so testing is not usually performed. However, knowing whether someone has M. pneumoniae infection is important for choosing the right antibiotic for treatment. Although real-time PCR assays exist for detecting this pathogen, they require sophisticated and expensive machinery as well as specialized technical expertise. CDC researchers have developed a simple loop-mediated isothermal amplification (LAMP)-based assay to detect this pathogen. This method only requires a simple heat block and is an easy-to-read colorimetric assay. The technology is simple to perform and can be a rapid point-of-care kit. It is ideal for use in resource-limited laboratories, hospitals, clinics, and community settings.

Potential Commercial Applications:		Competitive Advantages:
Detection of Mycoplasma pneumoniae from nucleic acid extracts and clinical specimens Rapid point-of-care testing (POCT) device or kit Research or clinical tool in fields of medicine, pharmacy, environmental hygiene, etc. Government or regional surveillance programs Quality control/quality assurance testing for Mycoplasma vaccine candidates		Rapid and simple diagnostic tool - Test development time is under 1 hour; newer reagents and enzymes may even improve time to results Similar sensitivity and specificity as compared to current commercially available kits for detecting M. pneumoniae in primary specimens Inexpensive and can be used in clinics or developing countries with little to no training Colorimetric assay is easy to read; no sophisticated instrumentation is required for performing or read-out Rapid and inexpensive diagnosis will facilitate proper use of antibiotics in pneumonia patients Can be used to improve currently available M. pneumoniae detection kits primarily used in hospitals and reference labs and approved for only throat swab testing - Works on many respiratory specimen types, can be performed directly on un-extracted specimens, is incredibly low cost at unde 50 cents per reaction, and can be performed and interpreted by technicians

Related Invention(s):
E-108-1989-0
E-125-1992-0
E-300-2013-0


Inventors:

Jonas Winchell (CDC)  ➽ more inventions...

Brianna Petrone (CDC)  ➽ more inventions...

Maureen Diaz (CDC)  ➽ more inventions...

Bernard Wolff (CDC)  ➽ more inventions...

Alexandra DeLaney (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 10,233,504 issued 2019-03-19
US Application No. 15/043,194

Publications:
Petrone BL, et al. PMID 26179304

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: Simple and Rapid Loop-Mediated Isothermal Amplification (LAMP)-based Assay for Mycoplasma pneumoniae Detection. For collaboration opportunities, please contact CDC TTO at tto@cdc.govor 1-404-639-1330.


Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-269-2014-0
Updated: Jun 22, 2018