Re-visiting the importance of Diagnostics in 2022

The Seventy-fifth World Health Assembly is being held in Geneva, Switzerland, from May 22-28, 2022. It is the first in-person Health Assembly since the start of the COVID-19 pandemic. On the occasion of the start of this assembly, many health-related organizations have released statements on healthcare priorities, inequities, and focus for the future.

Some of these observations relating to diagnostics caught our attention. We list four of them below and see them as further motivation for the work that we are doing at 3i Diagnostics.

  • The capacity to perform basic tests is available in just 1% of primary care clinics in low- and middle-income countries.
  • No diagnostic tests exist for 60% of the pathogens identified by the World Health Organization (WHO) as having the greatest outbreak potential. There are also no appropriate tests for half of the top 20 diseases responsible for the most lives lost.
  • Using COVID tests as an example, high-income countries use COVID tests at 10–100 times the rate of middle- and low-income countries. So, if tests are not inexpensive, testing is likely to be deficient.
  • Early diagnosis has been consistently linked to improved health outcomes and reduced out-of-pocket spending. However, diagnosis is the weakest link in healthcare systems globally.

One of the key learnings from COVID-19 is that investing in diagnostics will be central to rapid response to outbreaks and delivering appropriate care for infections. Deficiencies in testing affect not only people’s lives, but communities and economies, as COVID-19 clearly showed.

COVID-19 and opportunistic infections: The importance of Diagnostics

There has been a notion among many in the medical community that a significant proportion of the morbidity and mortality associated with COVID-19 are due to secondary bacterial infections. This notion is, in part, attributed to studies from the 2009 H1N1 epidemic (Morris et al. ) , and early reports detailing increased presence of other respiratory pathogens in COVID-19 patients (Gerberding , Zhou et al. , Zhu et al. ). Accordingly treatment of COVID-19 patients have frequently included antibiotics.

As Andrew Jacobs reported in his New York Times article, physicians heavily prescribed antibiotics for treating these patients because of this concern. It now appears that this possibility is not as pervasive or as severe as initially thought (Rawson et al.)

While the fear of opportunistic infections have not come to pass, the overuse of antimicrobials in treating COVID-19 patients has highlighted concerns about catalyzing a slower-moving crisis namely antimicrobial resistance (AMR). Overuse of antibiotics is one of the factors that induces the development of resistance and its spread, which is precisely what we have done over these past few months. 

What is interesting is that in both situations, COVID-19 and AMR, the immediate challenge has been our inability to identify those patients who need urgent medical attention. The challenges in testing subjects to determine if they are COVID-positive or not are well documented. Less well recognized is the situation in tackling AMR. 

In the case of AMR, while much attention has been devoted to developing new drugs, as they should, the fact is that the fundamental problem is that we do not know which drug to administer to treat the patient efficiently and rapidly. That is, it is at heart a diagnostic problem. As the US Government Accountability Office succinctly explain in their assessment of US efforts to combat AMRWithout information to guide test usage, clinicians may not be able to select appropriate treatments for their patients.

If you think that waiting for 48-72h to know if you were COVID-positive was unacceptable, why should it be for detecting bacterial infections, which could be just as, if not more, deadly (e.g. Sepsis)? [Today, it takes 1-5 days before the physician can learn if the patient has a bacterial infection or not]  As Dr. Strich of the NIH clinical center is quoted as saying, “being prepared is more cost effective in the long run” and saves lives. “Antimicrobial resistance is a problem we cannot afford to ignore.”

And yet, there is not the same sense of urgency in developing diagnostics that can rapidly determine if a patient has a bacterial or vial infection let alone what the infection-causing pathogen is. Efforts to develop better diagnostics are not sufficiently supported by either the private or the public sectors. 

We should all be asking ourselves why we are not pushing, with a greater sense of urgency, for better diagnostics that will be effective in combating AMR or the next pandemic instead of just hoping that the same approaches that have been tried for 20+ years with limited success will somehow suddenly provide the solution? 

COVID-19 once again highlights the importance of diagnostics

These are challenging times, and we, at 3iDx, hope that you, your loved ones, friends, and colleagues are well.

The COVID-19 pandemic has impacted the world in ways not seen in modern times. One of these is to bring back the importance of diagnostics and, importantly, the ability to perform tests in a multitude of settings.

It is abundantly clear that controlling the outbreak through social distancing severely impairs a functioning society. Any strategy to “reopen” a country is highly reliant on better testing, which is central to reducing transmission and morbidity and mortality. This not only involves being able to obtain an actionable result but also encompasses producing tests at a scale commensurate with the outbreak and addressing massive challenges in the supply chain.

While DNA-based diagnostic testing offers several reasons to include in our armament of tools. Waiting multiple hours or even days before getting a result for a COVID-19 test does not strike one as an effective strategy especially when battling reagent and buffer shortages.

While high-income countries are facing challenges in meeting the diagnostic needs of their rural and semi-urban populations, these challenges are magnified in low- and middle-income countries. These countries currently have the lowest rates of testing reported to the WHO.

It feels strange to be listing these problems and areas for improvement in yet another global crisis. We had earlier observed how our response to the antimicrobial resistance crisis is being held back because of inadequate diagnostics. The needs in both crises are eerily similar. We need rapid and inexpensive diagnostics that can be scaled easily and used outside a specialized laboratory setting. The options we currently have are not it.

The current COVID-19 crisis will draw down and we will emerge stronger. But if we are to emerge wiser from this experience, we need to invest more (resources, attention, capital) in diagnostic development.