SBIR Phase I: Specimen Suitability for Tuberculosis Testing

This Small Business Innovation Research (SBIR) Phase I project is for the development of a novel approach to standardize the diagnostic quality of clinical tuberculosis specimens and establish a clinical standard, a currently unmet clinical need. Accurate diagnosis of the disease cannot be obtained from poor quality samples irrespective of the method used. Clinical measurements have shown that as many as one out of four TB specimens collected have limited diagnostic value. Currently, there is no mechanism in place to identify these samples and consequently, they are a source for false-negative results. A novel technical approach is proposed to monitor the specimen quality of clinical samples directly and non-invasively at the point of collection and in real-time with a simple and easy-to-use device that is cost effective for widespread use. The availability of such a device would significantly impact the World Health Organization global strategy for the treatment and control of TB, both clinically and economically, by reducing the number of false negative results and affecting large savings from the efficient diagnostic testing and lessened spreading of the disease.