Addressing antibiotic resistance with a low-cost and transportable lab
“Since next generation diagnostics adapted for low-resource settings are unlikely to become available within the next 5 to 10 years, MSF has decided to develop a bridge solution with existing technology.”- Jean-Baptiste Ronat, Scientific and Technical Leader, Mini-Lab Project
Tell us about the problem you are trying to solve.
Each year, approximately 700,000 people around the world die due to infections that cannot be treated. Mini-Lab’s intent is to design and produce a transportable and low-cost laboratory that will allow trained non-expert users to diagnosis sepsis, conduct antibiotic sensitivity testing and manage surveillance at the hospital-level.
Antibiotic resistance (ABR) has become a global public health burden. ABR jeopardizes MSF’s medical interventions and hinders our ability to improve patient outcomes.
Today, there are many barriers to setting up diagnostic bacteriology labs in low-resource settings. These include high infrastructure costs, requirements for highly skilled staff, and close supervision as well as environmental and logistical constraints, including waste management, reagent shelf-life cold chain management, etc.
What is your solution? What motivates you to work on addressing this problem?
MSF is collaborating with experts to develop a small-scale, low-cost, stand-alone and transportable microbiology laboratory, known as the “Mini-Lab”. The Mini-Lab has the capacity to identify bacteria and its susceptibility to antibiotics for patients with bacteremia. These capabilities support the selection of the optimal antibiotic treatment for patients. As a result, Mini-Lab will improve both the quality of diagnosis and clinical care of patients with severe bacterial infections and contribute to understanding local ABR patterns.
This clinical-based ABR surveillance captures data to enhance empirical treatment guidelines and support field studies on diagnostic performance, infections, and prevention strategies. Hospitalized patients are a key focus, including severely ill children, malaria co-infected children, patients with burn wounds suspected of sepsis or patients living with HIV who have been admitted with fever.
Mini-Lab combines simplified logistics with robust and adapted techniques to maximize ease of use and response to the clinical needs of patients in low and middle-income countries. To address settings beyond the reach of conventional laboratory capacity, the techniques used in the Mini-Lab must be accessible to trained, yet non-expert users.
What have you done so far and what results have you achieved?
The project started in 2016 with the development of product specifications, which was supported by an external expert group. Based on research, market reviews and laboratory performance evaluations, the team chose available technologies and, in a few cases adapted tools for the Mini-Lab kit. By the end of 2018, with the support of TIC funding, the team constructed a full prototype of the Mini-Lab. In February 2019, the prototype was tested for three weeks in the Laboratoire Hospitalier-Universitaire de Bruxelles (LHUB) in Brussels. The team also deployed the first Mini-Lab prototype in field conditions in Port-au-Prince, Haiti with the first patients recruited this past summer.
“We have built a strong community of experts and future users for the Mini-Lab which shows the potential impact of the solution.”- Albane Mazoyer, Project Manager
What challenges have you faced? What lessons have you learned?
Related to MSF’s limited experience in product development, several factors have impacted our project timeline. These include difficulties in reaching a consensus during scientific discussions, the underestimation of technical complexity, and supplier delays.
Following performance studies, some of the selected technologies were abandoned and replaced by other solutions. In addition, difficult negotiations were faced with the manufacturer in charge of the development of the identification and antibiotic susceptibility testing plates used in the Mini-Lab. This difficulty was due to an underestimation of R&D requirements.
Despite the challenges, the Mini-Lab project structure has been progressively reinforced with the support of internal and external expertise. Building new capabilities always brings risk but we’ve gained valuable knowledge and experience as a result. This project is on track to deliver significant value and impact to our patients.
What is next?
Next steps for the Mini-Lab project include the following:
• Second Field Pilot: If the pilot in Haiti is successful, a second field pilot will be launched in early 2020. This second pilot will target a different field environment with a large pediatric population. The site will be chosen in the coming weeks (October 2019), likely in sub-Saharan Africa.
• Kit Finalization: The list of articles comprising the Mini-Lab kit will be finalized, incorporating important feedback from the field.
• Deployment: Defining the roll-out strategy of Mini-Lab within and beyond MSF is now a priority. This process will be conducted in coordination with the various MSF intersectional working groups and Mini-Lab stakeholders. This process also includes seeking partnerships and updating market surveys.
Are there any interesting partners that you are collaborating with?
The project is developed in collaboration with partners within the MSF movement worldwide and MSF satellites (Epicentre, Access Campaign). It is also built on strong external partnerships with the Institute of Tropical Medicine (ITM), the hospital of Kremlin-Bicêtre (association Cephyten), l’Ecole Nationale Supérieure d’Arts et Métiers (ENSAM) and the Laboratoire Hospitalier-Universitaire de Bruxelles (LHUB). External experts have guided the project through complex topics, negotiations and evaluations of products and manufacturers. Additional partners committed to the project include La Paillasse (a non-profit conception laboratory), Fondation Mérieux, Biologie sans Frontières, Cardiff University, Essex Hospital, Humatem, CHU Bichat and ABR WHO USA.
In addition, manufacturers of Mini-Lab components have become key stakeholders and partners in many ways – from developing and sourcing products to adapting solutions and even imagining new ones.
What is the expected long-term impact of the project? How will this project improve MSF’s lifesaving work and the lives of MSF’s patients?
In the long-run, the Mini-Lab will be deployed within and beyond MSF projects, and will support capacity-building for blood infection diagnosis in low-resource settings. As a result, it will enable practitioners to adapt antibiotic therapy for effective patient treatment and fight against antibiotic resistance. Finally, data collected will improve treatment guidelines and enable the surveillance of antibiotic resistance locally.