This is absolutely true! In fact, the emergence of COVID-19 has once again put the spotlight on diagnostics. It has demonstrated that strong test and trace capabilities can go a long way in any infectious disease management and not just COVID-19. However, the importance of diagnostics has long been under-recognized. Around the world, access to diagnostics remains poor, with 47% of the global population having little to no access to diagnostics. The recent Lancet Commission on diagnostics estimates that deaths can be avoided each year, by reducing the diagnostic gap for six priority conditions (diabetes, hypertension, HIV, and TB in the overall population, hepatitis B virus infection and syphilis for pregnant women). In relation to COVID-19, currently only 22.9% of tests administered worldwide have been used in low- and middle-income countries, despite these countries making up half of the global population. Identifying and closing these testing gaps is critical.
In India, although the definition of essential diagnostic service delivery at the primary healthcare level is well outlined, the highly fragmented and predominantly private provider network poses implementation challenges. Despite increasing investments, India suffers from an under-resourced health system, with shortages of skilled healthcare workers, supplies, quality-assured diagnostic services and disparate data management systems. Further, the lack of disease surveillance programmes has been identified as a fundamental barrier to healthcare delivery and controlling infectious diseases.
FIND is co-leading the Diagnostics Pillar of the Access to COVID-19 Tools (ACT) Accelerator (ACT-Accelerator), a collaboration to reduce death and severe disease through development, allocation, and delivery of COVID-19 tests, treatments, and vaccines. Its members share a commitment to ensure all people have access to the tools needed to defeat COVID-19.
When the second wave hit India, FIND reached out to the hardest-hit states to assess the most acute diagnostic needs. An initial support package of USD 1.1M was put together to augment the testing needs of public sector laboratories by provisioning high-throughput COVID-19 testing machines to reduce turnaround times. Further, support included increased access to rapid tests and enhancing sequencing capacity within India’s public sector. We are taking sequencing closer to the patient by setting up sequencing labs at district level. The initiative aims to optimize and scale the capacity needed to identify SARS-CoV-2 variants of concern (VOC) and identify mutations associated with disease severity that are critical for surveillance and public health action.
Partnerships are the core of our operating model. We bridge the public and private sectors, allowing us to bring a diverse set of stakeholders together to resolve technical, financial and logistical barriers to diagnostic innovation in low-resource settings. Our many partners include public, government donors, philanthropic organizations, commercial companies, academic and research institutions, international public health organizations (including non-governmental organizations and foundations), health ministries and disease control programmes.
Currently, FIND has many ongoing partnerships in India, which are disease specific. For instance, since 2010, FIND has been a key technical and implementation partner for the National TB Elimination Program (NTEP), Ministry of Health and Family Welfare, supporting its nationwide lab network of diagnostic services for TB. Further, through our private sector engagement program – Joint Effort for Elimination of Tuberculosis (JEET) – we are partnering with physicians, pharmacists and lab personnel across 24 states of India to increase identification and notification of TB patients, facilitate early treatment and provide adherence support for improved treatment outcomes. In the area of hepatitis C, FIND is working to build a simple, decentralised test and treat model of care, targeting prison populations across Punjab and Haryana. We also partner with key civil society organisations, to bring care (literally) at the doorstep of those who need it the most.
The identification of the Omicron variant has sparked growing concerns over its unusually high number of mutations and rapid spread, across the globe. Naturally, we have diverted our attention towards scrutinizing the veracity of the existing diagnostic tests on this new variant.
Analyses so far suggest that the rapid antigen (lateral flow) and gold-standard PCR tests should still detect the variant, but more comprehensive verification efforts are ongoing. A major issue is that many countries are still struggling with testing capacity for COVID-19 which is further complicated by supply chain issues and high costs for essential test reagents and limited funding to procure diagnostics. Testing rates in some countries remain worryingly low, creating blind spots where new variants like Omicron can spread unnoticed. FIND is investing US$21 million to accelerate the development, manufacturing, and launch of affordable point-of-care molecular diagnostic platforms that can detect multiple pathogens that cause diseases including COVID-19, in low- and middle-income countries. The investment will enable advanced COVID-19 testing rates, track the evolving epidemiology of the virus, including new variants; and optimize the use of tests to control the pandemic.
We have been working with Ministries of Health, academic institutions, technology companies, and other implementing partners to generate evidence on the use of digital tools for management of infectious diseases like TB and COVID-19, so that we can understand which tools are accurate and optimal for use in different situations.
Currently, we are collaborating with the Ministry of Health and Family Welfare, on the implementation of a laboratory information management system (LIMS) – software that allows laboratories to manage samples, test results and associated data to improve laboratory capacity. The use of LIMS has enabled public sector laboratories across the country to automate workflows thereby improving efficiency. LIMS has also enabled centralized management of patients’ demographic details and their specimen profiles; and management of tests and their respective results for each specimen, with the ability to add new or modify existing tests.
We are additionally working to develop and deploy digital connectivity solutions to enable seamless transmission of diagnostic data from the NTEP’s vast network of GeneXpert® and Trunat® platforms to the central data server Nikshay to facilitate improved patient management and disease surveillance. FIND is also developing RDT (rapid diagnostic test) data capture apps to enable accurate interpretation of COVID-19 antigen and other RDT test results as well as data management.
The pandemic has brought global attention to the importance of diagnostics and testing data to drive public heath decision-making. Although the threat of a global pandemic due to a rapidly spreading, lethal respiratory pathogen had been previously documented, funding for pandemic preparedness had been reactionary and not well sustained. Diagnostics have always been the cornerstone for early warning, response and containment, yet they remain chronically inappropriate for our needs.
India must build on and leverage broad COVID-19 testing capacity to establish sustainable early-warning and response systems for known and emerging pathogens. Our response to COVID-19 has created a tremendous opportunity to bolster overall pandemic preparedness and response. It has demonstrated the importance of investing in sequencing capacity for rapid pathogen and variant identification, and the benefit of open sharing of information to track pathogen evolution and spur rapid test development. Specifically, we need to:
1. Develop and deploy diagnostic tools to enable containment and clinical management of outbreak-prone pathogens. 2. Enable testing strategies and systems for community-based testing for COVID-19, in support of a return to normality 3. Create a permanent early-warning and response system through a global network to build resiliency
In The Lancet Global Health, Alexandra Hogan and colleagues conclude that, in high-burden settings, TB, and malaria deaths over a 5-year period could increase by 20%, and 36%, respectively, due to the knock-on and/or direct impact of COVID-19. The Global Fund conducts a biweekly qualitative survey across more than 100 countries in which it invests; the latest published results suggest that 78% of TB and 73% of malaria programmes are being disrupted due to COVID-19, with 17% of TB programmes, and 19% of malaria programmes experiencing high or extremely high disruption.
Mounting an effective response to COVID-19 and mitigating the impact on TB and malaria requires significant resources, including increased funding, training and protecting health workers, reinforcing systems for health, and responding to COVID-19 itself, particularly through testing, tracing and isolation and providing treatments as they become available. Significant financial contributions have already been announced by development partners, including by the Global Fund (C19RM), the World Bank, and other multilateral and bilateral partners to mitigate the impact of COVID-19 on HIV, TB and malaria.
Integration of multiplex diagnostic platforms, community level monitoring; implementing programs in partnerships with local governments, civil society and private sector; reinforced public messaging –are some of the avenues that can be strengthened to mitigate the impact of COVID-19 on diseases such as HIV, TB and malaria. An effective response to COVID-19 is also essential to protect the gains in TB and malaria and sustaining the momentum towards ending the epidemics.
