The Mini-Lab: accessible clinical bacteriology for low-resource settings
Authors: Alessandra Natale, Jean-Baptiste Ronat, Albane Mazoyer, Alice Rochard, Baptiste Boillot, Julie Hubert, Bernard Baillet, Marion Ducasse, Fabrice Mantelet, Saoussen Oueslati, Sien Ombelet, Céline Langendorf, Thierry Naas, Olivier Vandenberg, Jan Jacobs
Journal: The Lancet Microbe (2020)

Antimicrobial resistance represents a threat to global health-care systems. Low-resource settings especially struggle to diagnose and effectively treat bacterial pathogens.1WHOAntimicrobial resistance: global report on surveillance 2014.http://www.who.int/drugresistance/documents/surveillancereport/en/Date: 2014Date accessed: December 19, 2019Google Scholar In 2015, Médecins Sans Frontières (MSF) asked whether high-quality clinical bacteriology can be implemented in the most remote, challenging, and underserved areas of the world to improve treatment and surveillance of antimicrobial resistance infections. In July, 2019, MSF launched the first step to a possible answer. A field trial (unpublished) began, of the Mini-Lab; a transportable, self-contained, quality assured, stand-alone clinical bacteriology laboratory that can be operated by inexperienced technicians and used in low-resource settings. Previously, mobile laboratory solutions have focused on outbreak investigations and used containers, truck platforms, or pelican suitcases to transport and store minimally adapted laboratory equipment and consumables. Most mobile laboratory solutions use expensive molecular technologies that demand skilled technicians and are focused on single pathogen detection.2Kerber R Krumkamp R Diallo B et al.Analysis of diagnostic findings from the European mobile laboratory in Guéckédou, Guinea, March 2014 through March 2015.J Infect Dis. 2016; 214: S250-S257Crossref PubMed Scopus (28) Google Scholar, 3Petrova EV Avadhanula V Michel S Gincoo KE Piedra PA Anandasabapathy S Remote laboratory management: respiratory virus diagnostics.J Vis Exp. 2019; (published online April 6.)DOI:10.3791/59188Crossref PubMed Scopus (3) Google Scholar, 4Grolla A Jones S Kobinger G et al.Flexibility of mobile laboratory unit in support of patient management during the 2007 Ebola-Zaire outbreak in the Democratic Republic of Congo.Zoonoses Public Health. 2012; 59: 151-157Crossref PubMed Scopus (29) Google Scholar The Mini-Lab, designed by MSF and partners, is currently in prototype form and aims to respond to constraints in low-resource settings. The Mini-Lab was created by identifying a six building-block framework for clinical bacteriology in low-resource settings, and the built-in equipment can be operated by non-expert laboratory technicians without previous microbiology experience.5Ombelet S Ronat JB Walsh T et al.Clinical bacteriology in low-resource settings: today's solutions.Lancet Infect Dis. 2018; 18: e248-e258Summary Full Text Full Text PDF PubMed Scopus (63) Google Scholar It uses simple and affordable culture-based technology and quality-assured, standardised antibiotic susceptibility testing to improve patient care, provide surveillance data, and support the control of hospital-acquired infections.6Ombelet S Barbé B Affolabi D et al.Best practices of blood cultures in low- and middle-income countries.Front Med. 2019; 6: 131Crossref PubMed Google Scholar The Mini-Lab is patient-directed, built-for-purpose, guided by clinical reality, and not simply an entry-level version of its counterparts for high-resource settings.7Jacobs J Hardy L Semret M et al.Diagnostic bacteriology in district hospitals in sub-Saharan Africa: at the forefront of the containment of antimicrobial resistance.Front Med (Lausanne). 2019; 6: 205Crossref PubMed Scopus (12) Google Scholar, 8Archibald LK Reller LB Clinical microbiology in developing countries.Emerg Infect Dis. 2001; 7: 302-305Crossref PubMed Scopus (105) Google Scholar The Mini-Lab diagnoses bloodstream infections using a manual detection system (ie, not-automated), in which blood culture provides preliminary pathogen group classification, followed by full pathogen identification (biochemical testing) and antibiotic susceptibility testing (microbroth dilution method). Antibiotic testing panels meet the MSF field criteria (unpublished), WHO Essential Medicines List,9WHOWHO model lists of essential medicines.https://www.who.int/medicines/publications/essentialmedicines/en/Date: 2019Date accessed: March 12, 2020Google Scholar and WHO recommended Global Antimicrobial Resistance Surveillance System indicators.10WHOGlobal Antimicrobial Resistance Surveillance System (GLASS) report.https://www.who.int/glass/resources/publications/early-implementation-report/en/Date: 2018Date accessed: December 19, 2019Google Scholar A fully functional Mini-Lab prototype was first tested in a controlled environment in Brussels on January, 2019, and is currently being tested in an MSF hospital in Port-au-Prince, Haiti. The Mini-Lab is composed of six numbered and colour-coded bench-boxes, or workstations (figure). Each box contains equipment for its respective workstation and can be shipped as a kit or individually. Upon arrival, each box unfolds into a fully equipped and ready-to-use workbench; simplifying equipment ordering processes, overcoming procurement constraints, reducing laboratory set-up time, and organising workflow. If a hospital meets the minimal infrastructure requirements of having an available area around 20 m2, washable floors and walls, access to clean water, electricity (even if fluctuating), and waste disposal, then it can install a Mini-Lab. An integrated quality management system using the WHO Stepwise Laboratory Improvement Process Towards Accreditation criteria11WHOWHO Guide for the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) in the African region (with checklist).https://www.afro.who.int/publications/who-guide-stepwise-laboratory-improvement-process-towards-accreditation-slipta-africanDate: 2015Date accessed: March 12, 2020Google Scholar reduces inter-operator variability and errors, and includes; quality management manuals, equipment monitoring systems, specific standard operating procedures, and informative illustrated bench-aids designed for non-microbiology experts. Tablet-based guided data entry and workflow-assistance software were also designed for non-expert users to improve daily data entry, reduce transcription errors, increase reporting consistency, and coordinate surveillance data. Blood culture bottles, sub-culture media, identification and antibiotic susceptibility testing microplates, and other tests; are compact, ready-to-use, and affordable. These tests were chosen because they are easy to read, interpret, and can sustain the growth of common low-resource settings and tropical bacterial pathogens. These tests have long shelf lives (12–18 months) and can be stored at 4–25°C. To reduce cost, volume, and storage space, microplates are combined to identify gram-positive and gram-negative bacteria in one plate and context-relevant antibiotics are combined into three plates. Mini-Lab equipment is sturdy, safe, easy-to-use, requires little maintenance, and is adapted to challenging environments. The machines can withstand short power cuts and are dust safe. Waste management is integrated; an autoclave is part of the equipment included in the Mini-Lab allowing for the first step of waste processing. The autoclave is equipped with alerts for cycle and power interruptions. On-site training with theory and simulation modules (composed of a theoretical and practical session, with simulations of a typical laboratory day) provides knowledge to inexperienced laboratory technicians in a digestible way. Although far from being complete, the Mini-Lab development process has been characterised by successes, and the lessons learned are worth sharing. Validating diagnostic tests using clinically relevant pathogens should become standard practice for in vitro diagnostics manufacturers. Engaging with private industry should be encouraged to make these products more available to low-resource settings. The validation process supports the complexity of clinical bacteriology diagnostics and calls for more innovative technologies for low-resource settings. Antimicrobial resistance impacts health and the economy worldwide; however, hospitals and communities in low-resource settings are among the most affected.7Jacobs J Hardy L Semret M et al.Diagnostic bacteriology in district hospitals in sub-Saharan Africa: at the forefront of the containment of antimicrobial resistance.Front Med (Lausanne). 2019; 6: 205Crossref PubMed Scopus (12) Google Scholar, 12Jonas OB Irwin A Berthe FCJ Le Gall FG Marquez PV Drug-resistant infections: a threat to our economic future (Vol. 2): final report (English).http://documents.worldbank.org/curated/en/323311493396993758/final-reportDate: 2017Date accessed: March 12, 2020Google Scholar The Mini-Lab project shows that despite the challenges; engagement, inventiveness, and persistence might make it possible to bring clinical bacteriology solutions to even the most remote populations. We declare no competing interests. This project is entirely funded by Médecins Sans Frontières and we thank the organisation for their constant support in this project, and the support of stakeholders and health-care workers. We also thank the Scientific Committee members for their invaluable support and expertise, and Janet Ousley for editing this Comment.