On disease and diagnosis: Eliminating obstacles to RDT adoption

The first step in fighting an infection or disease is to label it correctly, i.e., to get an accurate diagnosis. If you live in a high-income country or a fairly well-developed urban area, this doesn’t seem like much of a problem. You visit the nearest lab or call a health professional to your home to collect a blood sample. You receive your reports in a few hours or a day, at most, and then take the best course of action as recommended by your doctor.

In many parts of the world, this is easier said than done. Even before getting to the treatment stage, medical expenses to get a diagnosis can burn a hole in people’s pockets or even be completely out of reach. Even if screening and diagnostic tests are affordable, in many low- and middle-income countries (LMICs), not all members of the population have equitable access to them. When there are ill-equipped or no healthcare centres within a reasonable distance from people’s homes, they have to travel several hours to get tested and seek other forms of medical support. All of these circumstances are exacerbated by issues like low supplies of diagnostics, low trust in modern medicine, and technological challenges that make it necessary to test frequently or wait long durations to receive results.

In the face of such challenges, many diseases go undiagnosed. While this is an unacceptable reality for all diseases, it is even worse when it comes to infectious diseases. With inaccessible or delayed diagnosis, patients’ health may deteriorate significantly. They may infect those in their community, and they may self-medicate without proper knowledge of what they’re suffering from, leading to problems like increased drug resistance.

If we want to improve people’s overall health and access to health services, let us start from the start – with diagnostics.

Finding the best tools to plug diagnostics gaps

The best way to close diagnostic gaps is to make low-cost diagnostics available at the point of care. Not only will such a solution help people get treated more appropriately, but it will also provide the data that governments and health organisations need to model epidemiological trends correctly.

An important thing to remember is that not all diagnostics are made the same. In selecting diagnostic techniques for resource-constrained regions, it is important to ensure that they meet the ASSURED criteria. This means that they should be affordable (A) to the target population, sensitive (S) so as to give few false negatives, specific (S) so as to give few false positives, user-friendly (U), and rapid (R) so that patients don’t have to make multiple trips to health facilities to get reports and start treatment. They should also be robust (R) in the face of inadequate cold storage infrastructure, equipment-free (E), and delivered (D) to those who need them the most.

Research has shown that rapid diagnostic tests (RDTs) (the most common form being immunochromatographic test strips or lateral flow assays) are best suited to bridge the access gap in disease diagnosis. They meet all the ASSURED criteria or at least have the potential to meet them with further research.

As their name suggests, RDTs are quick to deliver results. They can be designed to allow a single device to test for multiple antigens simultaneously. RDTs are most popularly and widely used for malaria testing—over 200 malaria RDT products were commercially available as far back as 2014. Hundreds of millions of malaria RDTs have been sold globally per year.

Barriers to widespread rapid diagnostics adoption

Regardless of the potential that RDTs have to revolutionise disease diagnosis in LMICs, there have been some significant challenges to their penetration in some contexts. These obstacles range from regulatory and social hurdles to economic and infrastructural ones.

Of these challenges, two stand out to us as the most significant.

Economic challenges. Rapid diagnostic tests are certainly cheaper and more accessible than other diagnostic tools. Nonetheless, their cost doesn’t always match what vulnerable populations can actually pay. For instance, about a decade ago, research in Uganda revealed that malaria RDT prices were roughly between USD 2.54 and USD 2.83 without subsidies. On average, however, consumers were only willing to pay USD 0.53. In other economies where most healthcare expenditure is out of pocket, there are similar problems. This significantly impacts the penetration of malaria diagnostics in low-income countries and communities.

The trust factor is also important here. Trust eroded by several circumstances means that people may spend on malaria medication even if they receive a negative test result. This adds to the total cost of malaria RDTs that we must consider.

There are two solutions to the cost problem. The first is for governments and international aid organisations to subsidise diagnostic tests. The second, more sustainable option is to localise diagnostics production. Making diagnostic tests locally can reduce costs significantly in the long term, especially given volatile foreign exchange rates that don’t often favour developing economies.

Unreliable supply chains. Supply chain disturbances are common in developing countries in Africa, Latin America, and South Asia. Research has cited healthcare workers blaming unreliable RDT supply as a major barrier to relying on them for affordable and accessible diagnosis. Product stock-outs are caused by very long lead times, seasonal surges in malaria caseloads, and poor inventory management.

Even in this situation, localising production is the answer. Shorter regional supply chains are less vulnerable to global shocks – this explains why many developed economies are also nearshoring manufacturing, applying lessons learned during the Covid-19 pandemic.

Partnering with PodTech to bring diagnostics to those who need them the most

The global community is already delayed in bringing to reality a vision for true health equity. Let us not delay the chance for improved health access anymore.

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In resource-constrained health systems in Africa, Latin America, South Asia, and beyond, pre-fabricated portable pharma factory systems are a no-brainer. They make biopharma manufacturing child’s play. They’re the ideal tool for indigenous companies, entrepreneurs, and governments looking to set their countries on the path towards robust health sectors and manufacturing self-sufficiency. PodTech makes it possible.