Research Project
9046418
DESCRIPTION (provided by applicant): Tuberculosis (TB) presents a major threat to global public health with 8.6M new active cases and over 1.3M deaths each year. The epidemic continues despite the fact that, once properly diagnosed, TB is curable. Over 100 years ago, Robert Koch demonstrated that Mycobacteria tuberculosis can be cultured from sputum of TB patients. Since then, sputum has been used as, and remains, the primary sample to diagnose active TB. However, three major challenges make sputum collection non-ideal for analysis. First, sputum has limited patient reach due to the inability to collect from children and adults wh are unable to expectorate. Second, sputum has limited diagnostic sensitivity due to poor sample quality. Finally, sample pre-processing necessitates adequate laboratory infrastructure and requires signi?cant safety precautions. Deton's patent-pending Coughlector? replaces sputum samples by capturing airborne bacteria directly from cough for subsequent diagnosis. The Coughlector? collects sample from potentially all patients, including children and patients who are unable to expectorate sputum. Furthermore, cough sample does not require pre-processing liquefaction and can be concentrated, boosting sensitivity. A preliminary small patient study pairs the Coughlector? with a CE-marked diagnostic. The results suggest cough may be more sensitive than sputum, though a larger study is required for a statistically signi?cant result. Te proposed work aims to evaluate the performance of cough samples with multiple FDA-cleared diagnostics, and to show that cough samples are at least as sensitive as sputum samples using one of the diagnostics. Speci?cally, the Phase I aims are to: (1) evaluate the performance of two FDA-cleared TB diagnostics with Coughlector? samples and (2) show the sensitivity of an FDA-cleared TB diagnostic with cough samples is equivalent to or better than its performance with sputum samples.
