Looking at the Big Picture: Using Point-of-Care Diagnostics to Advance a One Health Approach

Rory McCann:
I'm Rory McCann with Cambridge Healthtech Institute. I'm joined today by Dr. Konstantinos Mitsakakis who is Head of International Business Development at the Hahn-Schickard Institute for Micro Analysis Systems in Freiburg Germany. We are thrilled that he will be participating at the Molecular Diagnostics Europe Conference this May in Lisbon. He will be speaking in the Point of Care Diagnostics Program.

Dr Mitsakakis thank you for joining me today.

Konstantinos Mitsakakis:
Hello Rory, it's a great pleasure to talk with you today, and thank you very much for this opportunity to discuss about the topics that we work here in Freiburg.

Hahn-Schickard is a research organization that dedicates its research to development of micro systems for several fields. In our case for the field of diagnostics and healthcare.

Rory McCann:
Now your talk is about human, animal and vector diagnostics. Can you explain what this means, and what your one health approach is, and what is unique about it?

Konstantinos Mitsakakis:
Right. I will start with an example. We and several groups in the world are active in developing solutions for diagnosis of tropical infectious diseases. The most well-known is malaria, but there are also others such as dengue, chikungunya, and they all cause feverish symptom. However, when you consider where these diseases come from, it is the mosquitoes, the vectors who carry the pathogens and transmit them.

Therefore, to address only the human diagnostics in an isolated way without taking into account the surroundings, for example the mosquito prevalence and resistance to insecticides, entomology data and all this information, then the human diagnosis alone would be useless.

Then talking about animals in the environment. In numerous communities in the world, people live in very close proximity with their animals. And in such ecosystems of course, one must consider the environmental elements such as the water.

So imagine the situation now of having a contamination in the water line, say with salmonella enterica, which is a common bacterium causing gastro-intestinal infections. Humans get to drink the water, animals as well. Therefore in no time there is transmission of infection. Consequently this linkage and unavoidable connection between human, animal and environmental health is the one health itself.

Technology wise, the solution to address the challenges of one health is to develop diagnostic solutions that are compatible with human vector, animal and environmental monitoring. And due to these distinct fields, these technologies should be able to be deployed to the field. Or as we say, to the point of care or the point of need.

Rory McCann:
Now can you outline what you consider to be some of the greatest obstacles to developing technologies or applications for point of care diagnostics?

Konstantinos Mitsakakis:
So technology wise, it is a very challenging, but also very exciting field, because it requires the so-called heterogeneous integration. Now imagine that biochemical components micro systems, nano particles, they all have to be combined in a perfectly fitting and functional way at the very small scale.

A second obstacle that I would recognize is a non-technical one, actually. And it is the lack of willingness to change. End-user communities like general practitioners, entomologists, veterinarians, they are reluctant to use such equipments and change their traditional methods.

Now what can be a solution to this? In my opinion, a combination of two measures. First, there has to be really concrete clinical data. That is, evidence with such point of care devices, to prove that they perform at least as good or even better than thew current standards of care. For example in central laboratories. And at the same time that these devices are cheaper than the standard methods.

A second measure to overcome this unwillingness to change is, and this should be applied in parallel to the first measure, not sequentially, to run campaigns to inform the end users, but also the society, about the advantages of such systems, and to increase aware.

Then the awareness will bring a behavioral change, and subsequently the acceptability.

Rory McCann:
Tell me a little bit about how you've used the four disciplines to advance your research.

Konstantinos Mitsakakis:
Right, as four disciplines you refer to the molecular assays number one, point of care diagnostic systems number two, information communication technologies and behavioral change, I guess.

So the molecular assays are the hearts of a diagnostic system, no matter if it is for humans, animals or the environment. The molecular assays provide the specificity of detection, and consequently allow the suitable actions to be taken. These actions can be for example an antibiotic prescription in case of humans or animals, or the selection of a proper anti-mosquito spray in case of disease carrying vectors.

But to take these assays out of the lab in the field, these need to be packaged in a robust system that will be easily deployed to the field, and would require minimum hands-on steps by a user, and consequently minimum training of the user.

These are the point of care systems, or more generally point of need systems, that integrate those assays and enable them to operate exactly at the point where they're needed, as the word says.

So consider now that the system is deployed to the field, and it starts to give out some data. If the user needs to record these data manually, or if the data cannot be stored in a database, or cannot be sent to a regional or central authority, then the advantage of the system is lost.

And this is where the information technologies come into play. In other words, just the data by themselves may be meaningless. That is why some algorithms are necessary in order to co-assess all these data, and present them in a useful way to those who take decisions. And this is done with information technologies.

Now last but not least, assume that you have now all the above disciplines and components into a point of need system operating an an excellent way. Even if it is the best system, when the users are not convinced, or they are reluctant to use it, then the platform will stay in the drawer.

That means not only the the technical performance has to be perfect, but also the candidate users must be well informed and prepared for such technologies. And this is the meaning of behavioral change.

Rory McCann:
Has this experience given you greater insight that can be used to advise those developing technologies in the point of care space?

Konstantinos Mitsakakis:
Yeah, so through the years of working with projects international projects, yes there have been some conclusions that I have made. So for example my first recommendation would be, try to be interdisciplinary. The heterogeneous integration that we mentioned earlier makes it necessary that you must be able to communicate with medical doctors, entomologists, biochemists, engineers, information technologists, with understanding patience and openness of mind. And this is not trivial.

Then I would try to listen to the end users, what they really need. And then try to develop a solution that fits their needs, not more and not less. Do not over-engineer, and do not perform research for the sake of research, but on the other hand, also do not sacrifice quality.

And then, when you want to pass from laboratory proof of principle to clinical validation, try to find good sources of samples. No matter if they are bio banks in clinics, or from commercial sources, they must be of high quality, and they must be well characterized before you test them with your system.

Rory McCann:
That is some great advice. What emerging developments are you exited about, and how has your work been impacted?

Konstantinos Mitsakakis:
I would start with something that was not actually a development, but a global threat. In 2014 and '15 there was the Ebola outbreak. And shortly afterwards the Zika outbreak. These situations triggered millions and millions of investments on healthcare. And shortly afterwards there were many point of care or near patient diagnostic technologies emerging and approaching the market.

This increased the competition, and I would say in a good way, because that makes you want to become better and better.

Now technology wise, the past 20 years there has been a revolution in system miniaturization; micro fluidics, micro systems. And this has been accompanied by huge progresses in biochemistry. For example from traditional PCR technologies requiring thermo cycling, and quite some hours to be completed, we now have isothermal amplification, which can run in some minutes.

What we will experience in the future in my opinion is the more intense involvements of information technologies into these micro system based point of care platforms. Either in the form of artificial intelligence, or in the form of clinical algorithms, that receive as input multiple device data, and convert them into clinically meaningful results, and support the clinicians for better patient management.

Rory McCann
Dr Mitsakakis thank you so much for joining us today. We are really looking forward to your participation at Molecular Diagnostics Europe Conference. Thank you so much, and we will see you in Lisbon in May.

Konstantinos Mitsakakis:
Rory it was a great pleasure for me as well to interact with you, and to give the chance to the community and the society so to say, to get a few information about the work we do. And I also look forward to meeting you and to presenting our work in Lisbon in May.

Rory McCann:
Find out more from Dr Mitsakakis on Wednesday May 8th at 18:05. You can check out www.moleculardxeurope.com for more information.

Vejo-te em Lisboa!