Project Lead(s): Ruchika Raghuvanshi
Tuberculosis (TB) causes millions of deaths annually, worldwide. In 2011, there were 8.7 million new TB cases and 1.4 million TB deaths.
The current gold standard for diagnosis by cell culture is slow and may result in further progression; molecular diagnostic techniques are promising but not widely used.
There is a need for a rapid and effective diagnostic tool that is suitable for use in low-income settings.
The project team proposed to develop a rapid, sensitive and specific diagnostic test (lipid antigen detection kit) for pulmonary and extra-pulmonary tuberculosis.
The project involved a number of steps:
· identification of sero-reactive lipid antigens of tuberculosis
· development of polyclonal antibodies against lipid antigens
· development of monoclonal antibodies against lipid antigens
· purification of monoclonal antibodies
· development of a biosensor diagnostic platform.
A lipid-based liposomal diagnostic technology has been developed for the first time for TB detection.
The technology does not require any specific instrument, either to perform or to evaluate the result, and also does not require any specialized technical expertise for evaluation.
The time required to perform the test is less than five minutes.
The test could prove to be an effective and rapid tool for the screening and diagnosis of tuberculosis. The plan is to develop a biochip using the isolated monoclonal antibodies IgG and IgM.
A patent application is pending for the technology.
The project team plans to apply for Phase II Transition To Scale funding, to scale the large-scale monoclonal antibody production against the desired lipid antigens of Mycobacterium tuberculosis, followed by screening of the monoclonal antibodies for diagnostic efficacy in a large population.