title: Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.
abstract: BACKGROUND
  Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility.
  
  
  METHODS
  Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode.
  
  
  RESULTS
  The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012.
  
  
  CONCLUSIONS
  From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.
authors.forename: Willy
authors.initials: W
authors.lastname: Ssengooba
authors.forename: Sebastian J
authors.initials: SJ
authors.lastname: Gelderbloem
authors.forename: Gerald
authors.initials: G
authors.lastname: Mboowa
authors.forename: Anne
authors.initials: A
authors.lastname: Wajja
authors.forename: Carolyn
authors.initials: C
authors.lastname: Namaganda
authors.forename: Philippa
authors.initials: P
authors.lastname: Musoke
authors.forename: Harriet
authors.initials: H
authors.lastname: Mayanja-Kizza
authors.affiliation: Department of Medical Microbiology, Makerere University College of Health Sciences, School of Biomedical Sciences, P,O, Box 7072, Kampala, Uganda. moses.joloba@case.edu.
authors.forename: Moses Lutaakome
authors.initials: ML
authors.lastname: Joloba
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology; D019411:Clinical Laboratory Techniques / Q000191:economics / Q000592:standards*; D003906:Developing Countries / Q000191:economics; D005240:Feasibility Studies; D006801:Humans; D007753:Laboratories / Q000191:economics* / Q000458:organization & administration / Q000592:standards*; D008826:Microbial Sensitivity Tests / Q000592:standards; D011785:Quality Assurance, Health Care; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D014454:Uganda / Q000453:epidemiology
chemical_list: D000995:Antitubercular Agents