Executive Summary : | The prospective research project aims to develop a point of care diagnostic tool that can offer a rapid, sensitive, and cost-effective detection of tuberculosis (TB) among the Indian mass to enhance reporting of the TB cases and connect the missing millions with the National TB Elimination Programme (NTEP). The proposed sensor will be a chemiresistive-based platform equipped with all features, i.e., receiving the direct sample, sensing the presence or absence of respective targets, and displaying a confirmatory positive/negative report on an android based mobile phone. The gradual development of the research will be based on real sample tests provided by the partnered hospital, a heuristic approach for the determination of data patterns, optimized protocols and algorithms, and a design of a relevant low-powered read-out circuit.
TB is one of the most ancient diseases of mankind. It is among the top ten diseases in the world having the highest fatality rate, next only to HIV. As mentioned in India TB report 2020, India is the highest TB burden country globally with 24.04 lakh tuberculosis notifications in 2019 against 26.90 lakh cases estimated by WHO, indicating that almost 3 lakh patients missed out because of lower reporting of the national TB program. Even after being notified the surveillance of the patients is an issue of concern since 0.54 million cases are still missing in India. The report also tells that in the same year 27.74 crore population were screened across 337 districts in 23 states. The Most affected states which contribute to half of the total notifications are Uttar Pradesh (20%) Maharashtra (9%), Madhya Pradesh (8%), Rajasthan (7%), and Bihar (7%). The existing diagnostic technology which is mostly concerned with the microscopic detection of acid-fast bacilli (AFB) has poor sensitivity since AFB test requires at least 10,000 bacilli/ml of sputum to give a positive result below which the chance of giving positive results falls to 10%. Though sputum culture has better sensitivity than AFB test but its turnaround time goes to few weeks and further it requires biosafety level 3 facilities which are seldom available across TV endemic areas. Recently developed PCR techniques have much better performance since they have high sensitivity (97%) but they have poor specificity (49 % to 72%) because they detect total DNA present in the sample regardless of live or dead bacilli. Also, they can only detect active pulmonary TB (PTB) not latent pulmonary TB (LPTB). Moreover, all the sputum-based diagnoses rarely detect extrapulmonary TB (EPTB) which is mostly tested by sampling site-specific tissue. Thus, there is an indispensable need for a diagnostic technology that can tell us about the different stages and progression of TB in patients. It should be able to differentiate between the patients having an actual clinical TB, its latent form, and those who are cured of it. |