EIU
November, 2021
Executive summary
Diagnostics have played and continue to play a fundamental role in combatting the covid-19 pandemic globally — from identifying the causative pathogen, to tracking and interrupting the spread of disease, from informing vaccine design and research to monitoring variants of concern.
Progress in covid-19 diagnostics has happened at a rate that was previously unthinkable.
In less than a year from identification of the causative organism at the start of 2020, all 194 World Health Organization (WHO) member states were reported to have the capability to test for SARS-CoV-2.
Despite this, the covid-19 pandemic has also shed light on long-standing gaps in diagnostic preparedness and equitable access to diagnostics.
The importance of diagnostics has historically been under-appreciated, and therefore its provision under-resourced.
In order to prevent future pandemics it is likely that even more rapid development, evaluation and implementation of accurate in vitro diagnostics will be necessary, all the more so for novel diseases that can be spread by asymptomatic or pre-symptomatic individuals, as with covid-19.
A number of key actions are required to strengthen diagnostic preparedness and response. These include:
- Continuing and improving disease surveillance
- Investing in diagnostic research and development (R&D)
- Formalising flexible but rigorous regulation pathways to allow rapid diagnostic authorisation
- Diversifying diagnostic technologies, suppliers and manufacturers.
- Expanding laboratory capabilities and capacity worldwide
- Making improvements to computational systems and data sharing.
- Facilitating combined purchasing and improving financing mechanisms.
- Continuing and improving disease surveillance. The surveillance systems put in place after the SARS outbreak facilitated the rapid detection of the first cases of covid-19 in China. The availability of advanced sequencing techniques allowed identification of the novel pathogen and development of diagnostic tests within weeks of its emergence. Unfortunately, this was still not sufficient to curtail its spread on a global scale, hence the need for strengthening protocols for detection of novel threats and testing in outbreak areas in the future. Current surveillance systems tend to focus on known pathogens and known disease presentations; they must become more active and comprehensive, and encompass regular monitoring of potential emerging zoonotic diseases among wild animals and livestock.
- Investing in diagnostic research and development (R&D). For infectious diseases such as tuberculosis (TB) and many neglected tropical diseases that have been known for centuries there are still few simple, rapid, accurate point-of-care (POC) in vitro diagnostic tests. The rapid and successful development of a wide array of covid-19 diagnostics demonstrates what should be possible for other diseases. Progress is being made but it could be accelerated through greater prioritisation and investment. In addition to high-throughput laboratory-based methods, innovations that allow decentralised testing, and that do not require expensive laboratory facilities and equipment or highly trained staff, will be very beneficial for low- and middle-income countries (LMICs) and even hard-to-reach communities in high-income countries. Priority should also be given to platform technologies that can be rapidly adapted to new pathogens. Given the sheer volume of tests carried out worldwide during the pandemic, more sustainable and environmentally friendly diagnostic solutions should be factored in.
- Formalising flexible but rigorous regulation pathways to allow rapid diagnostic authorisation. The pandemic forced regulatory authorities to use streamlined versions of their usual approval processes, allowing diagnostic tests to be brought onto the market quickly. These processes may still be needed if new SARS-CoV-2 variants emerge that cannot be detected by the existing tests. They should incorporate mechanisms to assess emerging evidence on tests, so that authorisations can be rapidly revoked or altered as required. Formalising these pathways will enable better responses to future pandemic threats.
- Diversifying diagnostic technologies, suppliers and manufacturers. The bottlenecks seen in the diagnostic supply chain during covid-19 illustrate the need for a broader range of technologies, including those that are less reliant on proprietary reagents. Diversification of manufacturing centres and supply sources could also help alleviate bottlenecks, and contribute to reducing inequity of access to testing in regions where such facilities are currently limited.
- Expanding laboratory capabilities and capacity worldwide. Countries have struggled to reach the unprecedented levels of testing needed to control the pandemic. As a result, many have expanded their laboratory capabilities and capacity, which could leave a long-term legacy of strengthened health systems that are better able to detect and deal with current and future health threats (both communicable and non-communicable) and move us closer towards universal healthcare. Improvements must address not only laboratory facilities, but also the wider infrastructures needed to support them, such as staff training, quality assurance systems, IT systems and equipment maintenance.
- Making improvements to computational systems and data sharing. Timely sharing of genomic sequencing data for SARS-CoV-2 facilitated the development of diagnostic tests and vaccines, as well as epidemiological tracking. For the first time, data sharing enabled an almost real-time perspective on progress of the disease, usage of tests and demand. This has strengthened global efforts to contain covid-19, and it could do the same for other diseases. Robust data collection allows monitoring and linkage of diagnostic data to public health measures, such as contact tracing, localised testing and lockdown measures. Alongside expanding genomic sequencing capability globally, strengthened computational capabilities are needed to analyse the data generated and identify new variants as they arise. A well-governed network of biobanks for the collection and sharing of samples of these new variants is also important for the rapid development and evaluation of diagnostic tests. Some of these systems are being developed, but it is important that they are maintained in the long term.
- Facilitating combined purchasing and improving financing mechanisms. Pooled procurement through the multilateral Covid-19 Supply Chain System (CSCS) enabled LMICs to obtain lower prices and purchase an average of 55% of their covid-19 diagnostic supplies. Similar mechanisms should be explored in the longer term, with better financing mechanisms for capital-intensive activities like building laboratories and purchasing equipment. These steps are crucial for addressing inequitable access to testing.
While the pandemic has had a devastating impact, it may yet prove to be a catalyst for positive change if some of the systems being put into place to combat it are maintained, and these lessons learned.
Holistic systems that integrate diagnostics and diagnostic data with appropriate public health measures and access to vaccines and therapeutics are crucial going forward to bring an end to this pandemic — and for application to future pandemics.
It is in the interest of the health of all nations to ensure equitable access to pathogen surveillance and diagnostics globally, as well as vaccines, to ensure protection against such threats.
About this report
“The role of diagnostics in covid-19 and future pandemics” is a report by Economist Impact produced as part of The Economist Group’s Vaccine Ecosystem Initiative.
This Initiative examines what we have learnt from the herculean efforts and collaboration that has taken place between sectors and governments during the pandemic caused by SARS-CoV-2.
The Vaccine Ecosystem Initiative will explore avenues for building resilience and enabling equitable global access to vaccines, and to safeguard against future vaccine-preventable illnesses.
Our focus is on the five pillars that support the ecosystem:
- Research & Development;
- Manufacturing;
- Procurement,
- Pricing & Finance;
- Distribution,
- Logistics & Supply Chain Management; and
- User Acceptance & Uptake.
In addition, we will be looking at key cross-cutting issues that are crucial to the ecosystem, such as diagnostics.
In this report we look at the role that in vitro diagnostics (IVD) have played in the covid-19 pandemic.
We examine how that role has evolved, as well as the challenges and lessons learnt that may help us tackle future pandemics and other vaccine-preventable illnesses.
Our report focuses on two types of covid-19-related IVD methods:
- Diagnostic tests: These detect specific components of the SARS-CoV-2 virus and can be used to diagnose an infection. They include molecular tests (which detect viral genetic material) and antigen tests (which detect viral surface proteins).
- Serology/antibody and other acquired immune response tests: These detect antibodies to SARS-CoV-2 (such as IgM or IgG antibodies) or measure different types of immune response to the virus (such as the T cell response).
This report is based on a review of published literature and data, as well as insights gained from interviews with experts in the field. We would like to express our sincere thanks the following experts for sharing their knowledge and experience (in alphabetical order):
- Dr Kenneth Fleming, Chair of the Lancet Commission on diagnostics and Emeritus Fellow, Green Templeton College, University of Oxford, UK
- Dr Laura Kahn, Co-founder of the One Health Initiative, US, and Advisory Council Member of The Vaccine Ecosystem Initiative
- Professor Madhukar Pai, Canada Research Chair in Epidemiology & Global Health, and Associate Director, McGill International Tuberculosis Centre, Canada
- Dr Bill Rodriguez, Chief Executive Officer, FIND, Switzerland
The Vaccine Ecosystem Initiative is led by Dr Mary Bussell, who oversaw and edited this report.
The report was written by Dr Alicia White and Dr Rosie Martin with contributions and assistance from Bettina Redway, Elly Vaughan and Janet Clapton, and copy-edited by Maria Carter.
We are grateful for collaborative discussions with our Economist Intelligence colleagues, Dr Mark Whitten and Angela Kustas.
The Vaccine Ecosystem Initiative is supported by our founding sponsors MSD, a research-intensive biopharmaceutical company and leader in vaccines, and BD (Becton, Dickinson and Company), a leading global medical technology company, along with our silver sponsor, Siemens Healthineers.
The findings and views expressed in this report do not necessarily reflect the views of the sponsors or the experts we interviewed. Economist Impact bears sole responsibility for the content of this report.
Originally published at https://vaccineecosystem.economist.com/
