News and Opinions  –  2019

Constraints for successful implementation of diagnostics

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2019-04-04

When discussing and developing interventions to curb antibiotic resistance, it is important to consider the constraints, especially in many low- and middle-income countries (LMICs). Some interventions and technologies are simply not possible to implement – this holds true regardless of the novelty of the intervention, but becomes especially apparent for new high-tech innovations. The problems exist all over the field of innovation, but in this article, we’ll focus on diagnostics for illustration.

Photo: David Davies-Deis, Photoshare.

Technical capacity constraints

In many LMICs there simply are not enough clinical laboratories available to provide sufficient throughput with traditional, culture based microbiological methods, let alone with the most current high-tech laboratory methods. The problem is even greater in rural areas of low-income countries. For example, a stable electrical power supply may not be available, leading to power outages, spikes and fluctuations in frequency or effect. These instabilities can be devastating for state-of-the art, high-tech devices. Some of these problems could be alleviated by installing uniform power supplies (UPS) with battery backups, but that would be another piece of technology to purchase and uphold. In addition, the battery power in such units is rarely sufficient to do more than a safe shutdown of the equipment.

Staffing constraints

Hand in hand with the technical capacity limitation is the lack of trained technical staff. Many fast and highly reliable diagnostics require knowledge and skill to perform and interpret/analyze. However, in many countries there simply are not enough professional staff available. Training existing health care staff could be one solution to the problem, but would also lead to consequences for already strained health care systems. Further, many new methods require specialized training and dedicated laboratory scientists. Unless the national education system is able to provide sufficient numbers of trained professionals, new diagnostics have to be easy to use without a need for extensive training.

Financial constraints

In addition to the costs implied above, financing a new diagnostic will in many cases involve two costs: the investment cost in a new device, and the cost of performing an individual test. The initial investment cost may in many cases be covered by donations and international aid for low income countries as they are one-off costs. The greater problem is the cost of running the test. In countries where healthcare costs are largely paid for out of pocket, there is little direct incentive to pay for an expensive diagnostic. This cost may lead patients to buy medication rather than a correct, but more expensive, diagnostic (which may in the end also lead to an additional cost for a medicine). As the Indian physician Abdul Ghafur puts it:

“In India, I can prescribe a five-day course of antibiotics that costs my patient just under a dollar! Can you offer me a wonderful test that costs less than this magic number?”

Conclusions

If a new diagnostic tool is to be widely implemented in low-resource settings, the new method should be cheap, simple to use and not require laboratories or even stable power supply. While many new rapid diagnostic technologies may fulfil one or two of these criteria, few are able to fulfil them all. Unfortunately, much of the diagnostic research and development is performed in high-income countries, where these constraints are not always kept in mind. This way, many new and effective diagnostics like genomic analyses have been developed but are unfortunately not possible to use in low-resource settings. In this sense, the Longitude prize to develop a point–of–care diagnostic test is on the right track, requiring the winning technology to meet these and other criteria that make a new diagnostic valuable all over the world.