Diagnostic Preparedness for Pandemics

Despite years of warnings of such a pandemic occurring from public health authorities and researchers, the world was caught off guard by the novel coronavirus, SARS-CoV-2. Diagnostic testing to track the spread of the virus has lagged behind in most countries, leading to delays in putting critical measures, such as social distancing, in place.

Unfortunately, this likely won’t be the last pathogen to pose such a challenge to health care systems. What needs to be done to ensure labs are prepared for the next pandemic? Which pathogens are likely to cause the next outbreak? What diagnostic options currently exist for such pathogens, if any?

Citing the World Health Organization’s R&D Blue-print for Epidemic Preparedness, an analysis published last year in BMJ Global Health outlines 10 diseases and pathogens likely to cause future epidemics. Of those, six have “significant diagnostic gaps,” according to the article.¹ Since the novel coronavirus outbreak, COV-ID-19 has now been added to that list (see the table on the previous page for the diseases currently included in the list).

The WHO also lists “Disease X” as a threat which, according to its website, “represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease. The R&D Blueprint explicitly seeks to enable early cross-cutting R&D preparedness that is also relevant for an unknown Disease X.’”

Why diagnostic gaps exist

According to the BMJ Global Health article, none of the six WHO priority diseases with significant diagnostic gaps (CCHF, Lassa fever, Nipah disease, Henipavirus disease, Rift Valley fever, and Zika) have WHO-approved diagnostics. The remaining priority diseases face diagnostic challenges of their own, including limited availability of tests. We have already seen a significant diagnostic gap with COVID-19, which health authorities and diagnostics companies are quickly trying to close. 

There are several reasons why such large gaps exist in the creation of diagnostic tests for these diseases and pathogens. The key challenges to diagnostic preparedness that the authors outline are: fragmented and unreliable funding pathways; limited access to specimens and reagents; inadequate diagnostic testing capacity at both national and community levels of health care; and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods.¹ 

Funding issues 

 

Lack of funding for diagnostics research and laboratories has been shown to be a key problem in recent outbreaks, as pointed out by Seth Berkley, chief executive officer of Gavi, the Vaccine Alliance, in a 2018 Science editorial. Without accurate, fast, and reliable tests in developing countries, confirming and even properly diagnosing cases of Ebola during the beginning of the 2014 outbreak and of yellow fever in 2016 and 2017 was difficult and allowed those diseases to spread.²

Even in wealthier countries, properly funding diagnostics in preparation for future pandemics is an issue. Governments worldwide have not made pandemic preparedness a financial priority, according to a 2019 report by the World Bank Group.³ While the report said there was “increasing momentum” in many countries to create pandemic preparedness plans and identify weak points, it also pointed out that “little progress has been made in paying for these plans and integrating them into national budgets.”

Inadequate testing capacity

Lab capacity is already limited in developing countries, which often don’t have enough trained staff and supplies, and also lack adequate testing labs. Coupled with the lack of rapid diagnostic test kits that can be used in the field without training, delays in testing that allow disease to spread are inevitable. A deficiency of supplies and key reagents for testing kits was an issue during the outbreak of yellow fever in Nigeria in 2016-17.²

Developed countries also suffer from insufficient testing capacity, as we’ve seen in both the US and Canada during the current COVID-19 outbreak. A lack of supplies and key reagents for testing kits has been a critical problem in the US and other countries dealing with COVID-19, with the US only having 23 test kits per million people at one point and continually struggling with test backlogs.^4,5

Lack of incentives for R&D between outbreaks

Now that COVID-19 has turned into a pandemic, governments around the world are pouring money into developing diagnostic tests for the coronavirus. But prior to the outbreak, overall funding in R&D relating to pandemic preparedness left something to be desired, according to the World Bank report. The report gave governments a yellow “traffic light” ranking when it came to “Mobilizing funding for R&D for new product development and to strengthen clinical research capacities” stating that “Global, regional, and national preparedness R&D is insufficient; innovative financing approaches are needed.”³

Solutions for better diagnostic pandemic preparedness

The authors of the BMJ Global Health article say that solving these diagnostic challenges will involve many people in both public and private health care coordinating to implement “a holistic approach to diagnostics preparedness.” Their key recommendations include:

• Boosting diagnostic capacity, including health care worker education and surveillance of priority pathogens
• Developing diagnostics that require minimal sample preparation and training, and developing platforms that can rapidly adopt new assays
• Establishing a coordinating body for diagnostic funding
• Creating business models that incentivize manufacturers by offsetting losses during non-outbreak years
• Providing funding for stockpiling of tests
• Expanding the network of expert personnel and labs to enable knowledge sharing and a rapid response during outbreaks
• Pre-selecting suppliers of diagnostic materials for outbreak situations
• Implementing surveillance laboratory networks
• Educating health care workers on the importance of real-time reporting
• Looking into how solutions to similar challenges in vaccine development could be expanded to cover diagnostics

Despite these recommendations being published over a year ago, it is clear, based on the current coronavirus pandemic, that there is still work to do in the area of diagnostic preparedness for pandemics. The best efforts of WHO and other health authorities seem to have fallen on deaf ears when it comes to encouraging governments to invest in diagnostics R&D.

At the same time, there are encouraging signs, based on how these public health groups and others are coordinating efforts to handle the challenges of COVID-19 so far. For example, the Foundation for Innovative New Diagnostics (FIND), WHO, and their partners are working together to help low- and middle-income countries with “training, technical assistance, and capacity building to ensure access to accurate and high-quality diagnostic testing for SARS-CoV-2. ⁶ The Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), an international network of 28 major research funding organizations that helps ensure a quick response to outbreaks of infectious disease, is also coordinating with WHO to support the creation of better COVID-19 diagnostics.

Hopefully, once the COVID-19 pandemic has subsided, governments will recognize the critical need to fund rapid diagnostics and act accordingly to support the efforts of public health and research groups world-wide in preparing for the next pandemic.

References: 

1. Kelly-Cirino, CD, et al. “Importance of diagnostics inepidemic and pandemic preparedness.” BMJ Global Health. 2019;4:e001179.

2. Berkley, Seth. “Health security's blind spot.” Science. 359. 6380(2018): 1075.

3. World Bank Group. Pandemic preparedness financing: status update. 2019. https://apps.who.int/gpmb/assets/thematic_papers/tr-4.pdf

4. Muenz, Rachel. “Recent developments in COVID-19 diagnostic testing.” Lab Manager. 2020.

5. Ratanghayra, Neeta. “What led to reagent shortages for coronavirus testing in the US?” Clinical Lab Manager. 2020.

6. Foundation for Innovative New Diagnostics (FIND). “COVID-19 Diagnostics Resource Centre.” 2020. https://www.finddx.org/covid-19/.