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The world is woefully short of the diagnostic tests needed to respond to serious outbreaks of infectious disease, according to a new “readiness index” from FIND, the global non-profit organisation focused on building diagnostic infrastructure.
Although diagnostic technology is advancing rapidly, the only pathogen for which FIND experts found adequate availability of tests at all levels of healthcare was Sars-Cov-2, the virus responsible for Covid-19. For 20 other viruses and bacteria on the World Health Organization’s priority pathogen list, from mpox and Ebola to cholera and salmonella, preparedness “is severely lacking, putting lives and global security at risk”, says Geneva-based FIND.
Emmanuel Agogo, director of pandemic threats at the organisation, says Sars-Cov-2 made the grade because of the high priority given to fighting the Covid pandemic. “The findings of our index demonstrate an urgent need to accelerate investments and R&D to fill these concerning gaps in our diagnostic arsenals,” he says. “If we continue at this pace, we are driving head on to another catastrophe like Covid and many lives will be lost to infectious disease outbreaks that can be detected earlier with better access to testing.”
“Covid is the paradigm of what is possible, which should be built up for other infectious diseases,” says Neil Ward, a veteran of the genomics industry who is now vice-president of the gene sequencing company PacBio.
A panoply of diagnostics, using different technologies, is potentially available. At the top end for specificity is molecular sequencing, which decodes the DNA or RNA in the pathogen’s genome. It can be used to diagnose individual cases and for surveillance to detect the evolution of new genetic variants, as in the Covid pandemic.
Despite the enormous advances made over the past two decades in cutting the cost and time required for genome sequencing, however, “our products today do need a molecular biology lab — a hospital or an academic research setting,” says Ward. “An aspirational goal” is to produce sequencing devices that are small, cheap and simple enough to be used by family doctors and, eventually perhaps, by individual patients.
At the opposite end of the size and affordability scale are the disposable lateral flow tests with which millions of people became familiar during the pandemic. They detect proteins — an antibody or antigen — that are specific to particular pathogens, giving clear yes-or-no results within a few minutes.
“The concept of lateral flow tests received a big boost from the pandemic and it is probably the future for rapid diagnostics,” says Paul Tambyah, president of the International Society for Infectious Diseases. The range of pathogens for which LFTs are available is growing fast and now includes malaria as well as viruses and bacteria. Some “multiplex” tests are designed to detect more than one pathogen in the same sample, such as Covid and flu.
“We want to understand the bottlenecks that are limiting the wider availability of diagnostics,” says Agogo. “Regulatory harmonisation is one of the biggest bottlenecks. Even when the tests are available, there’s disparity between when and how they can be used in different countries. We have to build capacity that allows data to be transferred and evaluated in different jurisdictions.”
Ward agrees. Covid had regulatory bodies largely waive their normal processes and “set up accelerated procedures for generating approved diagnostics”, he says. “We’ve reverted now to the standard process of regulatory approval for diagnostic tests, which is costly and quite a high barrier to the market for technology providers.”
Effective global surveillance for emerging pathogens with pandemic potential depends on immediate international sharing of significant diagnostic information, without unfairly penalising countries whose labs discover new variants or pathogens.
“With Covid we saw real conflicts of interest, for example when the South African scientific community did a great job of detecting early genetic variation in the virus and the world penalised South Africa by locking down flights there,” says Ward. “So it’s not just the funding required to set up an early warning system. It won’t work if people are worried that they’ll become pariahs as soon as they raise a flag.”
The alert system that warned the medical world about Covid on December 31 2019 was ProMED, run by the International Society for Infectious Diseases. ProMED had previously picked up the related coronaviruses that caused Mers and Sars, says Tambyah. “There’s a trendy approach using big data surveillance, analytics and artificial intelligence but [in contrast] ProMED is the only human, curated, event-based worldwide surveillance system.”
ProMED ran into financial trouble last year and suffered a month-long staff strike but Tambyah says its future has been secured. One step was to restrict access to ProMED’s archive to subscribers while all alerts within the past 30 days remain freely available.
As a system based on human experts and human intelligence — and not relying on health ministries and other official sources — “ProMED is a vital part of the whole surveillance system,” Tambyah says.
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