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Normal Clinical Laboratory Ranges by Age and Sex, and Impact on Study Screening Outcomes in Rural Mali.
M'Bouye Doucoure1, Amatigue Zeguime1, Amadou Niangaly1
1Malaria Research and Training Center, International Center for Excellence in Research-MALI, University of Sciences, Techniques and Technologies of Bamako, Mali.
The American Journal of Tropical Medicine and Hygiene
|March 26, 2024
Summary
Establishing local reference ranges for laboratory tests in healthy Malian adults is crucial. This study provides vital hematological and biochemical data for West African vaccine trials and clinical care.
Area of Science:
- Clinical Laboratory Science
- Hematology
- Clinical Chemistry
Background:
- Laboratory test interpretation relies on reference ranges from healthy populations, which can vary geographically, by sex, and by age.
- Existing reference ranges used in Malian laboratories are often based on non-local data, potentially leading to misinterpretation of results in healthy individuals.
Purpose of the Study:
- To establish local reference intervals for hematological and clinical chemistry parameters in healthy individuals in Mali, West Africa.
- To assess the prevalence of abnormal laboratory values in a healthy Malian population using current manufacturer-based ranges.
- To identify sex-based differences in these parameters within the study population.
Main Methods:
- Analysis of peripheral blood samples from 1,192 healthy individuals (6 months to 82 years) at two rural sites in Mali (Bancoumana and Doneguebougou).
- Laboratory tests included complete blood count (CBC), creatinine, and alanine aminotransferase (ALT).
- Data were analyzed using College of American Pathologists-accredited laboratory standards and compared against manufacturer-provided reference ranges.
Main Results:
- A significant proportion of healthy adult participants exhibited abnormal values: 30.4% for neutrophils and 19.8% for hemoglobin.
- Sex-based differences in parameters like hemoglobin, platelets, and absolute neutrophil counts were observed in older individuals (>10 years) but not in younger children.
- Creatinine levels also showed sex-based variations in older participants.
Conclusions:
- Current manufacturer-based reference ranges may lead to a high rate of detected abnormalities in healthy Malian populations.
- Site-specific reference intervals are essential for accurate interpretation of hematological and biochemical data in Malian clinical trials, including those for malaria vaccines.
- The generated reference intervals can improve diagnostic accuracy in routine clinical care within Mali.
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