Article Category:
Research Article

Normal Clinical Laboratory Ranges by Age and Sex, and Impact on Study Screening Outcomes in Rural Mali

M’Bouye Doucoure Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Amatigue Zeguime Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Amadou Niangaly Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Merepen A. Guindo Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Justin Y. A. Doritchamou Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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Mahamadoun H. Assadou Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Abdoulaye Katile Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Moussa B. Kanoute Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Sidiki Perou Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Adama Ouattara Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Sintry Sanogo Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Boucary Ouologuem Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Souleymane Traore Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Bakary Dao Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Drissa Dembele Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Mamady Kone Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Bourama Kamate Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Kourane Sissoko Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Seydou Sankare Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Sadio Diarra Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Amagana Dolo Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Mahamadou S. Sissoko Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Jennifer C. C. Hume Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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David Cook Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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Sara A. Healy Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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J. Patrick Gorres Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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Boubacar Traoré Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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Jordyn Gamiel Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland

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Patrick E. Duffy Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;

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Issaka Sagara Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali;

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DOI:
https://doi.org/10.4269/ajtmh.23-0719
Volume/Issue:
Volume 110: Issue 5
Page(s):
1021–1028
Restricted access
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ABSTRACT.

The interpretation of a laboratory test result requires an appropriate reference range established in healthy subjects, and normal ranges may vary by factors such as geographic region, sex, and age. We examined hematological and clinical chemistry parameters in healthy residents at two rural vaccine trial sites: Bancoumana and Doneguebougou in Mali, West Africa. During screening of clinical studies in 2018 and 2019, peripheral blood samples from 1,192 apparently healthy individuals age 6 months to 82 years were analyzed at a laboratory accredited by the College of American Pathologists for a complete blood count, and creatinine and/or alanine aminotransferase levels. Based on manufacturers’ reference range values, which are currently used in Malian clinical laboratories, abnormal values were common in this healthy population. In fact, 30.4% of adult participants had abnormal neutrophil levels and 19.8% had abnormal hemoglobin levels. Differences by sex were observed in those who were older, but not in those younger than 10 years, for several parameters, including hemoglobin, platelet, and absolute neutrophil counts in hematology, and creatinine in biochemistry. The site-specific reference intervals we report can be used in malaria vaccine clinical trials and other interventional studies, as well as in routine clinical care, to identify abnormalities in hematological and biochemical parameters among healthy Malian trial participants.

    • Supplemental Materials (PDF 353.99 KB)

Author Notes

Financial support: This work was supported by the Division of Intramural Research of the National Institute of Allergy and Infectious Diseases, NIH.

Disclosure: Clinical studies were conducted under protocols (ClinicalTrials.gov ID NCT03917654 and NCT03304704) approved by the Institutional Review Board of the National Institute of Allergy and Infectious Diseases and the ethics committee of the Faculty of Medicine, Pharmacy and Odontostomatology of Mali. Community permission was obtained from village leaders; written individual informed consent was obtained from each participant. Assent forms were used for all study participants between 12 and 17 years of age who were capable of giving assent to participate. Parental consent was obtained for all study participants younger than 18 years.

Authors’ addresses: M’Bouye Doucoure, Amatigue Zeguime, Amadou Niangaly, Merepen A. Guindo, Mahamadoun H. Assadou, Abdoulaye Katile, Moussa B. Kanoute, Sidiki Perou, Adama Ouattara, Sintry Sanogo, Boucary Ouologuem, Souleymane Traore, Bakary Dao, Drissa Dembele, Mamady Kone, Bourama Kamate, Kourane Sissoko, Seydou Sankare, Sadio Diarra, Amagana Dolo, Mahamadou S. Sissoko, Boubacar Traoré, and Issaka Sagara, Malaria Research and Training Center, International Center for Excellence in Research–MALI, University of Sciences, Techniques and Technologies of Bamako, Mali, E-mails: mbdoucoure@icermali.org, amatigue@icermali.org, niangaly@icermali.org, agnes@icermali.org, mmaiga@icermali.org, katile@icermali.org, mbkanoute@icermali.org, sperou@icermali.org, adamaouattara@icermali.org, sintry.sanogo@icermali.org, ouologuem@icermali.org, traoresolo@icermali.org, bakary.dao@icermali.org, drissa.dembele@icermali.org, mamady@icermali.org, boukamate@icermali.org, kouranes@icermali.org, seydousankare@icermali.org, konidiarra@icermali.org, adolo@icermali.org, mssissoko@icermali.org, bouba.traore@icermali.org, and isagara@icermali.org. Justin Y. A. Doritchamou, Jennifer C. C. Hume, David Cook, Sara A. Healy, J. Patrick Gorres, and Patrick E. Duffy, Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, E-mails: yai.doritchamou@nih.gov, jennifer.hume@nih.gov, david.cook@nih.gov, sara.healy@nih.gov, john.gorres@nih.gov, and patrick.duffy@nih.gov. Jordyn Gamiel, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, E-mail: jordyn.gamiel@nih.gov.

Address correspondence to Patrick E. Duffy, 29 Lincoln Dr., Bldg. 29B, Bethesda, MD 20852. E-mail: patrick.duffy@nih.gov
Copyright:
© American Society of Tropical Medicine and Hygiene 2024
Received:
18 Oct 2023
|
Accepted:
04 Jan 2024
|
Published Online:
26 Mar 2024
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
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