Deployment of iMC2 - point of care TB Device

Name of the Grantee:
Valetude Primus Healthcare (VPH)

Summary:
Valetude Primus Healthcare Pvt. Ltd. has developed the immuno-magnetic cell capture technology (iMC2) that can be used at the community level to replace sputum smear microscopy for diagnosing tuberculosis (TB).

The point-of-care iMC2 TB device has novelty in the design (including sample collection), technological (immuno-magnetic cell capture) and operational (no sample exposure to health worker) aspects along with high sensitivity and specificity of disease diagnosis. Desired specificity and sensitivity of Mycobacterium TB detection is achieved by using highly specific antibody against 19 kDA surface antigen and a novel enrichment technology (Indian Patent:485/DEL/2015), respectively with inbuilt fluorescence detector. Using 100 nm multicore super paramagnetic dextran coated nanoparticles they are able to increase the efficiency of binding and using unique collection technology we are able to enrich the cells by 100X to a final volume of 10 µL with >80% efficiency within 1 hour of results time. 

iMC2 -TB also eliminates the need for collection of sputum samples by healthcare workers as patients can directly spit the sputum in their specially designed capture bottles. Healthcare workers won’t be exposed to extremely contagious pathogen, Mycobacterium tuberculosis.

Impact Factor:
iMC2 -TB has an integrated IoT sensor using which results would be available at the central server and will be directly accessible by healthcare organizations (such as the WHO) and state-run TB control initiatives like the RNTCP (Revised National Tuberculosis Control Program) to detect outbreaks of TB.

Problem Statement:
India has the highest burden of TB in the world. 2.8 million new cases and more than 480,000 deaths in 2016 are a poignant reminder of the threat that this epidemic continues to pose despite concerted efforts by the Indian government to curb it. Although the Indian government has chalked out an ambitious plan to eliminate TB by 2025, it is able to notify only 58% of TB patients. A person infected with TB, if left undiagnosed, can infect 10-15 healthy individuals in a single year. Sputum smear microscopy is the most commonly used test for diagnosing TB. It is performed manually and is time consuming; a laboratory technician is expected to spend at least 15 minutes per slide, limiting the number of slides that can be screened. Medical specialties that are commonly solicited in TB diagnosis, such as imaging and microbiology, depend heavily upon the interpretation of bacterial morphology by healthcare workers. Due to the stress of heavy workload in microscopy centers in high burden countries like India, healthcare workers often fail to detect all TB cases. Lack of coordination and inconsistent follow-up by frontline healthcare workers has necessitated the minimization of human intervention for effective diagnosis of TB at the community level

Outcome: 
Use of iMC2 will ensure No sample exposure to health worker; Easy to use portable battery- operated device; with short turn-around time per assay ~1 hour and it can connected to real-time surveillance (NIKSHAY) and patient monitoring with no need for additional investment into manpower and infrastructure