Volume 86, Issue 4
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices.


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  1. Dicko A, Sagara I, Diemert D, Sogoba M, Niambele MB, Dao A, Dolo G, Yalcouye D, Diallo DA, Saul A, Miller LH, Toure YT, Klion AD, Doumbo OK, , 2007. Year-to-year variation in the age-specific incidence of clinical malaria in two potential vaccine testing sites in Mali with different levels of malaria transmission intensity. Am J Trop Med Hyg 77: 10281033. [Google Scholar]
  2. Dicko A, Klion AD, Théra MA, Sagara I, Yalcouyé D, Niambele MB, Sogoba M, Dolo G, Dao A, Diallo DA, Doumbo OK, Miller LH, , 2004. The etiology of severe anemia in a village and a periurban area in Mali. Blood 104: 1198200.[Crossref] [Google Scholar]
  3. Dicko A, Sagara I, Ellis RD, Miura K, Guindo O, Kamata B, Sogoba M, Niambelé MB, Sissoko M, Baby M, Dolo A, Mullen GE, Fay MP, Pierce M, Diallo DA, Saul A, Miller LH, Doumbo OK, , 2008. Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children. PLoS One 3: e1563.[Crossref] [Google Scholar]
  4. Sagara I, Ellis RD, Dicko AA, Niambelé MB, Kamata B, Guindo O, Sissoko MS, Fay MP, Guindo MA, Kante O, Saye R, Miura K, Long C, Mullen GE, Pierce M, Martin LB, Rausch K, Dolo A, Miller LH, Doumbo OK, , 2009. A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults. Vaccine 27: 72927298.[Crossref] [Google Scholar]
  5. Coulibaly YI, Dembele B, Diallo AA, Lipner EM, Doumbia SS, Coulibaly SY, Konate S, Diallo DA, Yalcouye D, Kubofcik J, Doumbo OK, Traore AK, Keita AD, Fay MP, Traore SF, Nutman TB, Klion AD, , 2009. A randomized trial of doxycycline for Mansonella perstans infection. N Engl J Med 361: 14481458.[Crossref] [Google Scholar]
  6. Sagara I, Dicko A, Ellis RD, Fay MP, Diawara SI, Assadou MH, Sissoko MS, Kone M, Diallo AI, Saye R, Saye R, Guindo MA, Kante O, Niambelé MB, Miura K, Mullen GE, Pierce M, Martin LB, Dolo A, Doumbo OK, Saul A, , 2009. A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali. Vaccine 27: 30903098.[Crossref] [Google Scholar]
  7. Dembele B, Coulibaly YI, Dolo H, Konate S, Coulibaly SY, Sango D, Soumaoro L, Coulibaly ME, Doumbia SS, Diallo AA, Traore SF, Diaman Keita A, Fay MP, Nutman TB, Klion AD, , 2010. Use of high-dose, twice-yearly albendazole and ivermectin to suppress Wuchereria bancrofti microfilarial levels. Clin Infect Dis 51: 12291235.[Crossref] [Google Scholar]
  8. Ellis RD, Dicko A, Sagara I, Kamate B, Guindo O, Niambelé MB, Sogoba M, Doumbo O, , 2008. Short report: elevated levels of alanine aminotransferase and hepatitis A in the context of a pediatric malaria vaccine trial in a village in Mali. Am J Trop Med Hyg 79: 980982. [Google Scholar]
  9. Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA, , 2006. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 42: 377382.[Crossref] [Google Scholar]
  10. CLSI, 2000. How to Define and Determine Reference Intervals in the Clinical Laboratory: Approved Guideline. Second edition. Wayne, PA: National Committee for Clinical Laboratory Standards. C28-A2, Vol.20 No 13. 2ed. [Google Scholar]
  11. Eller LA, Eller MA, Ouma B, Kataaha P, Tumusiime R, Wandege J, Sanga R, Sateren WB, Wabwire-Mangen F, Kibuuka H, Robb ML, Michael NL, de Souza MS, , 2008. Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials. PLoS One 3: e3919.[Crossref] [Google Scholar]
  12. Ohrt C, Obare P, Nanakorn A, Adhiambo C, Awuondo K, O'Meara WP, Remich S, Martin K, Cook E, Chretien JP, Lucas C, Osoga J, McEvoy P, Owaga ML, Odera JS, Ogutu B, , 2007. Establishing a malaria diagnostics centre of excellence in Kisumu, Kenya. Malar J 6: 79.[Crossref] [Google Scholar]
  13. Ohrt C, O'Meara WP, Remich S, McEvoy P, Ogutu B, Mtalib R, Odera JS, , 2008. Pilot assessment of the sensitivity of the malaria thin film. Malar J 7: 22.[Crossref] [Google Scholar]
  14. Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP, Giersing BK, Mullen GE, Orcutt A, Muratova O, Awkal M, Zhou H, Wang J, Stowers A, Long CA, Mahanty S, Miller LH, Saul A, Durbin AP, , 2005. Phase 1 clinical trial of apical membrane antigen 1: an asexual blood-stage vaccine for Plasmodium falciparum malaria. Infect Immun 6: 36773685.[Crossref] [Google Scholar]
  15. Ellis RD, Fay MP, Sagara I, Dicko A, Miura K, Guindo MA, Guindo A, Sissoko MS, Doumbo OK, Diallo D, , 2011. Anemia in a phase 2 study of a blood stage falciparum malaria vaccine. Malar J 10: 13.[Crossref] [Google Scholar]

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  • Received : 04 Nov 2011
  • Accepted : 18 Jan 2012
  • Published online : 01 Apr 2012

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