Antibiogo

Antibiogo is a transformative digital health solution designed as a Software as a Medical Device to enhance antimicrobial stewardship in LMICs. It equips laboratory technicians with advanced tools for accurate interpretation of Antimicrobial Susceptibility Testing, facilitating improved diagnostics, effective AMR surveillance, and comprehensive capacity building in the absence of microbiologists.

Dr Nada MALOU, is a PhD in microbiology with 10 years experience in implementing microbiology laboratories in LMIC with Medecins Sans frontieres. 

Antimicrobial Resistance (AMR) is today one of the major public health threats, which could cause up to 10 million deaths every year by 2050 if we don't act now. AMR drivers are various, including the lack of access to quality-assured bacteriology testing.

The deployment of clinical bacteriology diagnostics in Low and Middle-Income Countries (LMICs) faces significant obstacles. These include a lack of suitable reagents and consumables, the high cost of diagnostic tests, infrastructural shortcomings, and a severe deficit in specialized personnel, notably microbiologists. Whereas laboratory technicians with no experience in bacteriology can be trained to perform the test, they are not trained to accurately interpret tests, especially Antimicrobial Susceptibility Testing that recquires the application of up to date expert rules. It was estimated that 400 years of training are needed in Sub-Saharan Africa to achieve the microbiologist-to-population ratio of high-income countries.

This stark reality highlights the pressing need for affordable, accessible, and scalable solutions for AST interpretation, allowing a task shifting from microbiologists to laboratory technicians in order to ensure acurate interpretation of AST for optimal patients managements and to improve surveillance data even at lowest level of health system where microbiologists are not available

Laboratory technicians in LMIC are the intended users. The objective of Antibiogo is to support the task shiffting of the interpretation step from microbiologists to lab technicians. The app is also intended to build the capacity of lab tech in their understanding of some of the expert rules.

The Antibiogo app was developped by LMIC lab tech for LMIC lab tech to treat patients in LMIC. Several usability studies including formative and summative studies were organized from the initial stage of teh project. All features were developped based on LMIC lab tech users feedbacks.

In addition, we collect from routine use, users feedbacks in order to adapt and improve the App design at each stage.

• Antibiogo provides the possibility to interpret AST even in absence of microbiologists as it is the case in LMIC.
• the app will be open source except the expert system.

 Accurate Antibiotic Susceptibility Testing (AST) results from Antibiogo lead to improved patient outcomes by ensuring the administration of the most effective antibiotics. This  helps preventing complications, such as amputations in war-wounded patients, and reduces hospital stays.

Antibiogo democratizes access to microbiology at the lowest levels of the healthcare system, even where skilled professionals are scarce. It enables the prompt identification of MDR by detecting multidrug-resistant (MDR) organisms early, allowing hospital management and Infection Prevention and Control (IPC) teams to implement necessary measures, including patient isolation.

Capacity building is another core benefit. Antibiogo's user-friendly interpretations aid in educating laboratory technicians , enhancing their understanding of antibiotic spectrums and resistance mechanisms. It also serves as a training tool for clinicians, fostering a deeper comprehension of the nuances involved in antibiotic resistance.

Furthermore, Antibiogo enhances Antimicrobial Resistance (AMR) surveillance and the formulation of locally tailored guidelines. By delivering precise results and facilitating data analysis, it enables laboratories to contribute to national and WHO surveillance efforts. This collaboration results in the availability of local data on etiology and resistance, critical for updating empirical treatment protocols, thus driving forward the global fight against AMR.

Initial Phase - Targeted Implementation in MSF Labs (End of 2022 to End of 2023): We've successfully executed the first step, introducing Antibiogo within MSF's laboratory network on a limited scale to ensure quality and gather initial feedback.

Expansion Phase - Partnership with Health Ministries: Now, we're setting our sights on a broader implementation, working alongside Health Ministries in the numerous countries where MSF is active. Our discussions extend across various nations to integrate Antibiogo into their healthcare frameworks, with support from the EUCAST development laboratory and ICARS for validation. We're also engaging with key AMR entities, such as the Fleming Fund, to champion Antibiogo as an all-encompassing AMR solution.

Access-for-All Phase: The ultimate goal is to offer Antibiogo to any LMIC lab without cost or access barriers, aiming for widespread adoption and impact. This phase is crucial for making Antibiogo a global tool in the fight against AMR.

To aid in the transition to broader use, we're not just relying on direct implementation support but also developing an e-learning platform. This online and offline resource will empower users to independently adopt and maximize Antibiogo, reinforcing our commitment to accessible, effective healthcare solutions.

As the legal manufacturer of Antibiogo, we are obligated to conduct post-market surveillance activities. This involves proactive data collection at various sites where the app is utilized. Additionally, we are in the final stages of enhancing our analytics capabilities.

The enhancement of AST (Antibiotic Susceptibility Testing) quality can be evaluated through two distinct approaches:

1. Programmatic Approach: Laboratories employing Antibiogo will have access to a straightforward protocol for a programmatic assessment of pre and post-intervention. This includes analyzing specific bacteria with designated expert rules before and after Antibiogo's implementation, such as the percentage of aminoside resistance in Salmonella.
   

2. Operational Research: We are in the process of developing a protocol for operational research to accompany some future implementations. The goal is to evaluate the impact of Antibiogo on AST results and on patient treatments.

Further analytics, such as the number of laboratories using the app and the number of ASTs processed through the app, will aid in the continuous evaluation of user feedback and the adoption of the tool. These measures are critical for understanding how Antibiogo is being utilized in real-world settings and for identifying opportunities for improvement to ensure the tool meets the needs of its users effectively.

The primary challenge we face involves obtaining the new IVDR (In Vitro Diagnostic Regulation) certification for introducing new features to Antibiogo. This process is significantly influenced by the availability of an EU notified body. We are making progress in this area and are in the process of finalizing a collaboration with a notified body, with an audit scheduled for September 2024.

As of now, the certified version of the app supports only EUCAST guidelines. The integration of the CLSI knowledge base is contingent upon receiving final certification. This limitation may influence the selection of countries for Antibiogo's implementation, particularly in regions where CLSI guidelines are predominantly used.

Regarding the sustainability of funding, the MSF Foundation currently bears the entire cost associated with the development and maintenance of the app. However, as the number of laboratories utilizing Antibiogo grows, we recognize the need for exploring alternative funding models to ensure the project's long-term viability. We are actively investigating various options to support this transition.

At the scale up and implementation stage, we think that Trinity challenge is adapted to teh scope of the activities in the coming years.

 We think that the innovative approach of having a non profit humanitarian organization becoming a legal manufacturer for digital health tools for LMIC  proving a solution for free is a unique appraoch and we believe that it is a unique opportunity to tackle the issue of legal manufacturing for all these digital solutions that should be affrodable for LMIC

• Fleming Fund
• Africa CDC
• ASLM