Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

Merepen A. Guindo Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Merepen A. Guindo in
Current site
Google Scholar
PubMed Close
,
Joseph P. Shott Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Joseph P. Shott in
Current site
Google Scholar
PubMed Close
,
Renion Saye Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Renion Saye in
Current site
Google Scholar
PubMed Close
,
Moussa L. Diakité Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Moussa L. Diakité in
Current site
Google Scholar
PubMed Close
,
Sintry Sanogo Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Sintry Sanogo in
Current site
Google Scholar
PubMed Close
,
Moussa B. Dembele Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Moussa B. Dembele in
Current site
Google Scholar
PubMed Close
,
Sekouba Keita Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Sekouba Keita in
Current site
Google Scholar
PubMed Close
,
Mary C. Nagel Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Mary C. Nagel in
Current site
Google Scholar
PubMed Close
,
Ruth D. Ellis Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Ruth D. Ellis in
Current site
Google Scholar
PubMed Close
,
Joan A. Aebig Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Joan A. Aebig in
Current site
Google Scholar
PubMed Close
,
Dapa A. Diallo Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Dapa A. Diallo in
Current site
Google Scholar
PubMed Close
, and
Ogobara K. Doumbo Mali International Center for Excellence in Research (ICER), Malaria Research and Training Centre (MRTC), Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), University of Bamako, Bamako, Mali; Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland; Global Health Partnerships (GHP), Clinical and Laboratory Standards Institute (CLSI), Wayne, Pennsylvania; Laboratory of Malaria Immunology and Vaccinology (LMIV), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland

Search for other papers by Ogobara K. Doumbo in
Current site
Google Scholar
PubMed Close
DOI:
https://doi.org/10.4269/ajtmh.2012.11-0691
Volume/Issue:
Volume 86: Issue 4
Page(s):
573–579
Restricted access
Get Permissions

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.

Author Notes

*Address correspondence to Joseph P. Shott, 33 N Drive, MSC 3207, Bethesda, MD 20892. E-mail: ShottJ@mail.nih.gov

Financial support: The clinical laboratory is financially supported by the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under contract no. HHSN261200800001E. This research was supported (in part) by the National Institute of Allergy and Infectious Diseases.

Disclosure: RS was employed by the MRTC/FMPOS at the time of this activity. MCN was employed by GHP/CLSI at the time of this activity.

Authors' addresses: Merepen A. Guindo, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: agnes@icermali.org. Joseph Shott, OD, DIR, NIAID, Bethesda, MD, E-mail: ShottJ@mail.nih.gov. Renion Saye, USAID-Mali, Bamako, Mali, E-mail: saye@icermali.org. Moussa L. Diakite, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: mldiakite@icermali.org. Sintry Sanogo, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: ssanogo@icermali.org. Moussa B. Dembele, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: moussab@icermali.org. Sekouba Keita, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: Sekouba@icermali.org. Mary C. Nagel, Laboratoire National De Sante Publique, Ministry of Health, Port au Prince, Haiti, E-mail: mcnagel@live.com. Ruth D. Ellis, LMIV, DIR, NIAID, Rockville, MD, E-mail: ellisru@niaid.nih.gov. Joan A. Aebig, LMIV, DIR, NIAID, Rockville, MD, E-mail: jaebig@niaid.nih.gov. Dapa A. Diallo, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: dadiallo@icermali.org. Ogobara K. Doumbo, Mali ICER, Malaria Research and Training Centre, University of Bamako, Mali, E-mail: okd@icermali.org.

Copyright:
©The American Society of Tropical Medicine and Hygiene 2012
Received:
04 Nov 2011
|
Accepted:
18 Jan 2012
|
Published Online:
01 Apr 2012
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
  • 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 : 1028– 1033.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 1198– 200.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 7292– 7298.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 1448– 1458.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 3090– 3098.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 1229– 1235.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 980– 982.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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 : 377– 382.

  • 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.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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.

  • 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 : 3677– 3685.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 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.

    • PubMed
    • Search Google Scholar
    • Export Citation
Past two years Past Year Past 30 Days
Abstract Views 579 438 36
Full Text Views 555 3 0
PDF Downloads 139 4 0
 
 
 
 
Affiliate Membership Banner
 
 
Research for Health Information Banner
 
 
CLOCKSS
 
 
 
Society Publishers Coalition Banner
Save