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• In 2025, Antibiogo’s quality management system earned ISO 13485 certification, an international standard for medical device manufacturers. According to Antibiogo’s website, this was a first for a non-governmental initiative in this field and showed that a tool built for low-resource settings could meet the same safety and reliability requirements as commercial devices [9]. 

Relevance to Africa 

Across African healthcare systems, point-of-care microbiology labs frequently struggle with structural supply deficits and staffing constraints [15].  

Antibiogo addresses these structural hurdles through multiple field-tailored capabilities: 

• Operates entirely offline on standard mobile phones, maintaining complete functionality during power cuts or in locations without cellular networks [16]. 

• Helps lab personnel reliably interpret complex growth inhibition patterns without needing an on-site specialist [10]. 

• Eliminates the need to import expensive automated plate readers, allowing low-resource facilities to expand their diagnostic services affordably [9]. 

• Generates standardized AST data locally using EUCAST and CLSI guidelines, then exports it directly into WHONET (the software WHO uses for GLASS reporting) through a desktop utility called AST Merge [16]. This means a technician’s result on a phone in a district hospital can become part of a national surveillance dataset without retyping or reformatting. 

Current Status and Implementation Challenges 

1. Antibiogo’s accuracy depends on the photograph taken of the test plate, and phones vary in camera quality. The project addresses this by setting a minimum requirement of a 12-megapixel Android camera and by using a simple, self-built “photo booth” to ensure pictures are taken under standardised conditions for correct analysis [17]. Because EUCAST and CLSI guidelines are updated annually, the app’s knowledge base is also updated, and users must download the latest version, making calibration and maintenance an ongoing task rather than a one-off fix. 
2. While the digital app is free and lightweight, laboratories still need consistent supplies of basic, quality-controlled agar plates and antibiotic discs to perform the tests [18]. 
3. ACE mark is a European certification but, not a global one. The MSF Foundation’s regulatory documentation confirms that, beyond CE marking, the project must meet local regulatory requirements and obtain necessary regulatory approvals for key markets, with a dedicated Software as a Medical Device (SaMD) regulatory role handling this workstream [19].  

The Way Forward 

Antibiogo has already proven that a technician with a smartphone can produce an interpretation a clinician can act on, and it has been certified as a medical device and used in MSF laboratories across several countries [10]. The question now is whether it becomes standard practice in African laboratories or remains a well-regarded project that never quite settles into routine use. 

The answer lies in decisions the app itself cannot make, beginning with regulation. Every country maintains its own medical device authority, and a European CE mark carries no automatic weight before any of them, which means MSF’s regulatory team is working through national approvals in one jurisdiction at a time. A small humanitarian organisation cannot realistically carry that load for an entire continent, so ministries will need to take ownership of their own registration pathways.  

A certified device must be updated whenever international treatment guidelines shift and supported when laboratories run into problems, and MSF has itself named long-term financing for maintenance and updates as a priority it has not yet secured [20]. Without that commitment, the tool’s durability rests on funding that goes beyond a single project cycle. 

Antibiogo was designed for technicians without specialist microbiology training, but it still assumes they can prepare and read a plate correctly. That is a skill someone has to teach and then keep sharp through supervision and refresher sessions, not a single workshop. 

At Ducit Blue Solutions (DBS), as we continue to explore bold ideas leading to emerging solutions and transformative innovations, we remain steadfast in our commitment to advancing patient safety and strengthening health systems that delivers high-quality healthcare services for all. Innovation goes beyond new technologies or approaches but about creating sustainable impact that improves outcomes and builds resilient systems that place people at the centre of care.