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Why better diagnostics

There is increasing concern by the global community that life-saving medicines be available to treat diseases in the developing world, in particular AIDS, tuberculosis and malaria. The UN Security Council passed a resolution in 2001 declaring the three diseases to be a global security risk and formed a global financing mechanism known as the Global Fund to Fight AIDS, Tuberculosis and Malaria which mobilises resources to enable lower income countries to deliver adequate treatment and care.

But focus on the delivery of medicines by itself is not sufficient. A huge challenge remains, namely, taking the right decision on who needs to be treated. The tools or tests available in the developing world for diagnosing these and other poverty related diseases are largely out-dated and ineffective, while newer tools already available in industrialised countries are either not affordable or are not designed for use in the developing world settings. The inability to properly diagnose diseases frustrates care providers, reduces patient’s faith in the healthcare system, results in huge mistreatment, and wastes precious resources.

In tuberculosis for instance, the world spends US$ 1 billion on diagnosis globally, but the return on this investment is disappointing. The mainstay for TB diagnosis remains the cumbersome, 100-year old tool, the microscope. Diagnosis via microscopy usually takes up to 5 days as the patient has to provide multiple sputum samples for precise diagnosis. In Malawi, this process costs the patient up to 15 working days worth of wages. What is more, microscopy is insensitive, especially in areas where HIV is prevalent, and many patients are overlooked by false readings. Overall, fewer than 25% of the nearly 9 million new cases of TB each year are reported as having been detected by microscopy.

For malaria, misdiagnosis is also an enormous problem: 50-80% of the fever episodes treated on the basis of signs and symptoms for malaria are not confirmed in parasitological testing. Simple, accurate, robust and affordable point of care tests are not available for most patients seen in community clinics. A number of rapid tests that can detect malaria antigens in a finger prick blood sample have been developed over the past decade, but inadequate sensitivity, high cost, and instability at tropical temperatures continue to plague these tests, limiting their impact. One consequence of this lack of accurate local testing is an estimated 500 million treatments for malaria each year in people suffering from some other cause of fever.

For many of the other poverty related diseases, such as human African trypanosomiasis (sleeping sickness), for which there is no commercial market to drive any test development, confirmatory point of care tests are lacking altogether. For sleeping sickness, confirmation depends on microscopic detection of the parasites in blood, lymph glands or cerebrospinal fluid, which is very difficult in field conditions.

While repeat visits and multiple tests can compensate for inadequate diagnostics in industrialised countries, such redundancies are not available in resource-limited health systems. Thus, impoverished populations need diagnostics that are better, not worse, than those in industrialised countries. At the level of the individual, lack of accurate tests leads to delay in treatment, multiple clinic visits, and misdiagnosis, all of which result in direct health and financial costs that developing world patients and health systems can ill afford.