Last Updated:  24/09/2020

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Project Pitch By: Foundation for Innovative New Diagnostics India

 

Proposed Project Title


Tackling the dual challenge of TB and COVID: an integrated, multi-disease screening model

 

Thematic Area

Eradicating hunger, poverty and malnutrition, promoting health care, sanitation & safe drinking water

Sub Thematic Area

Healthcare Donations (Ambulance, Equipments, Money Etc.)

Project Synopsis

The COVID-19 pandemic needs rapid response from health systems especially in high-density, urban areas. The pandemic has severely affected health programs like TB severely impacting case detection. India, which has the highest number of TB cases in the World, has reported ~46% fewer TB cases between March-June 2020 compared to last year. There are many overlaps between TB and COVID-19 related to disease presentation, transmission and control strategy. Studies have shown that TB is a major risk factor for COVID-19 and ~5%9 of the COVID-19 patients are coinfected with TB. Based on this the MOHFW has now issued bidirectional TB-COVID screening guidelines. FIND proposes strategically placed testing labs, in consultation with local authorities, for COVID-TB testing and equipped with a “Made in India” rapid RT-PCR platform approved for both COVID-19 and TB testing. These sites will conduct bi-directional screening and further link to MOHFW for further action.
 
 
 

Overview of the Proposed Project

Estimated Budget
INR 1.0 Cr - INR 5.0 Cr
Proposed Location
Delhi, Hyderabad

Key Project Partners
Government,Municipal Corporation

Project Status
Proposed
 

Facts

Beneficiary Type (Primary): General
Beneficiary Type (Secondary): General
Estimated No. of Beneficiaries: above 10000 Individuals
Status of Baseline Survey: Yet To Be Done
 
 
 

Proposed Project Description

The ongoing COVID-19 pandemic requires health systems to move at a rapid pace to contain the transmission and caseload. This is even more pertinent for potentially high transmission areas such as those with high population densities where social distancing is difficult to implement. Indian metropolitan cities like New Delhi and Hyderabad have high population densities (nationally and globally) at 11,320/sq. km and 18,170/sq. km respectively. These two cities have been severely affected by the COVID-19 pandemic accounting for more than 5% of India’s case load (~280,000) as per official reports as of 24th September 2020. While Indian cities demonstrated initial successes in curbing new cases, they have since seen a resurgence with much higher numbers. Overall, these cities face a major challenge in containing COVID-19 in a sustained manner, which needs to be addressed through increasing access to rapid diagnosis of disease leading to early isolation and appropriate clinical management.


COVID-19 pandemic has also had a cascading and catastrophic effect on other health programs especially tuberculosis (TB). As per a recent report due to COVID-19, TB related deaths over 5 years may increase by ~20% compared to if there were no pandemic. The world will likely see 6.3 million additional cases of TB and 1.4 million additional TB deaths between 2020-25. This is especially detrimental for India which accounts for the highest number of TB cases in the World, with an estimated 2.7 million people suspected of TB in India – as per WHO’s Global TB report 2019. Similar to global trends, the number of TB cases notified in India between March and June 2020 were ~46% fewer than during the same months last year. The reasons for this drop may include reluctance of the symptomatics to seek medical help due to stigma, movement restriction, fear of infection at health facilities, re-direction of health facilities/ TB lab capacities towards Covid-19 screening and testing as well as overall interruption in TB health programs.


For diagnosis of both TB and COVID-19, RT-PCR tests remain the gold standard with its high sensitivity and specificity for both diagnosis.  For COVID-19 testing, recently rapid antigen tests have been introduced which have enhanced the testing capacity. However, since these tests miss ~30% cases (false negatives) samples which still need retesting with RT-PCR. Since RT-PCR laboratories are few in number, centralized, with limited capacity and are subsequently overwhelmed, the COVID-19 suspects currently face delayed testing and communication of results.  This not only delays the diagnosis but also the subsequent isolation and clinical management of the COVID-19 patients and containment of the area as required. In addition, the patients suspected to have COVID may be suffering from TB as well. Considering that there are common diagnostic platforms (rapid RT-PCR) for both TB and COVID, there is a potential opportunity to screen the patients for TB and COVID simultaneously on site thus rationalizing resources. This approach can help identify and manage COVID-19 and TB patients early and appropriately, identify potential hotspots for COVID-19) and allow rapid demarcation of containment and quarantined areas, and prevent further transmission.


To combat this dual challenge, FIND India proposes to introduce labs (either mobile or health facility based), in each of the two metro cities equipped with a rapid RT-PCR platform, the Truenat™ which is approved for diagnosis of COVID-19 (Truenat Beta CoV approved by ICMR) and TB (Truenat MTB Plus). The Truenat™ platform is a chip-based RT-PCR test approved by the Indian Council of Medical Research (ICMR) for COVID testing. It is also widely used by the National TB Elimination Program (NTEP)  for diagnosis of TB and drug resistant TB. The Truenat™ is a locally developed technology that is highly attractive due to its portable (battery operated) nature, lack of need of temperature-controlled environment and rugged design. This point-of-care device can be deployed in a de-centralized manner for diagnosing COVID-19 and TB patients with results available in ~1.5 hours.


In partnership and consultation with the local authorities, strategic locations for operating the lab would be decided (eg: proximal to drive-through antigen testing centres or COVID-19 testing camps) with agile change of location as per changing testing needs. At these sites, the project team will assist city authorities in conducting retesting of symptomatic antigen negative suspects  as well as assessing COVID-19 suspects for TB symptoms through a verbal questionnaire and as per the algorithm defined by the MOHFW. If a suspect displays or reports symptoms of TB, the project would facilitate collection and testing of the sputum sample either at the project lab or at the nearest NTEP diagnostic facility. Post diagnosis, the project will ensure linkage of TB patients to the city’s TB program for treatment initiation with reporting of TB results on the NTEP’s web-portal Nikshay while COVID-19 patients will be linked as per clinical algorithm recommended by ICMR.

 
 

Salient Features

  1. Bi-directional testing of TB/COVID-19 within an innovative integrated testing laboratory in line with Govt of India’s directive
  2. Decentralised RT-PCR testing resulting in rapid public health action for both COVID-19 and TB thus rationalising resources and saving out of pocket costs for the patients who may otherwise opt for private sector testing facilities due to delayed results at public sector labs
  3. Last-mile connectivity of testing in urban hotspots
 

About Foundation for Innovative New Diagnostics India

The Foundation for Innovative New Diagnostics or FIND is a global, non-profit organization based in Geneva and dedicated to accelerating development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases. FIND is a World Health Organization (WHO) Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. Since 2003, FIND has been instrumental in development of 24 new diagnostic tools. Over 50 million FIND-supported products have been provided to 150 low- and middle-income countries since the start of 2015.


FIND India is registered as a Section 8 company since 2015 with an independent board of directors, pan-India presence, strong financial and programmatic track records. From 2010 onwards, FIND has been a key technical and implementing partner of the Ministry of Health and Family Welfare, Government of India for sustenance and expansion of its nationwide laboratory network for drug-resistant Tuberculosis (TB) diagnostic services, pandemic and outbreak preparedness, viral hepatitis, anti-microbial resistance and fever-causing disease such as malaria. Recently, in response to the COVID-19 pandemic, FIND India has mobilized a spectrum of activities from conducting of independent evaluations of prioritized COVID-19 tests to driving availability of diagnostic capacity via supply of testing equipment , over 38,000 tests and related consumables.

 
 

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