Determining hematological, biochemical and immunological reference values in healthy adults with high-risk for HIV acquisition in Mozambique

PLoS One. 2020 Apr 30;15(4):e0232018. doi: 10.1371/journal.pone.0232018. eCollection 2020.

Abstract

Introduction: In many African countries, laboratory reference values are not established for the local healthy adult population. In Mozambique, reference values are known for young adults (18-24yo) but not yet established for a wider age range. Our study aimed to establish hematological, biochemical and immunological reference values for vaccine trials in Mozambican healthy adults with high-risk for HIV acquisition.

Methods: A longitudinal cohort and site development study in Mozambique between November 2013 and 2014 enrolled 505 participants between 18 to 35 years old. Samples from these healthy participants, were analyzed to determine reference values. All volunteers included in the analysis were clinically healthy and human immunodeficiency virus (HIV), hepatitis B and C virus, and syphilis negative. Median and reference ranges were calculated for the hematological, biochemical and immunological parameters. Ranges were compared with other African countries, the USA and the US National Institute of Health (NIH) Division of AIDS (DAIDS) toxicity tables.

Results: A total of 505 participant samples were analyzed. Of these, 419 participants were HIV, hepatitis B and C virus and syphilis negative including 203 (48.5%) females and 216 (51.5%) males, with a mean age of 21 years. In the hematological parameters, we found significant differences between sex for erythrocytes, hemoglobin, hematocrit, MCV, MCH and MCHC as well as white blood cells, neutrophils and platelets: males had higher values than females. There were also significant differences in CD4+T cell values, 803 cells/μL in men versus 926 cells/μL in women. In biochemical parameters, men presented higher values than women for the metabolic, enzymatic and renal parameters: total and direct bilirubin, ALT and creatinine.

Conclusion: This study has established reference values for healthy adults with high-risk for HIV acquisition in Mozambique. These data are helpful in the context of future clinical research and patient care and treatment for the general adult population in the Mozambique and underline the importance of region-specific clinical reference ranges.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Blood Cells / chemistry*
  • Blood Platelets / chemistry
  • Cohort Studies
  • Female
  • HIV Infections / blood
  • HIV Infections / prevention & control*
  • Hematocrit / standards
  • Hematologic Tests / standards*
  • Hemoglobins / analysis
  • Humans
  • Leukocyte Count / standards
  • Leukocytes / chemistry
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Mozambique / epidemiology
  • Reference Values
  • Risk Factors

Substances

  • Hemoglobins

Grants and funding

This work was supported by a cooperative agreement (W81XWH-07-2-0067) between the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and the U.S. Department of Defense (DOD). This research was funded, in part, by the U.S. National Institute of Allergy and Infectious Diseases. Material has been reviewed by the Walter Reed Army Institute of Research. There is no objection to its presentation and/or publication. The opinions or assertions contained herein are the private views of the authors, and are not to be construed as official, or as reflecting true views of the Department of the Army, the Department of Defense, or the National Institutes of Health. The investigators have adhered to the policies for protection of human subjects as prescribed in AR 70–25. Financial assistance was provided by the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. to the Instituto Nacional de Saúde (INS) under the terms of the Clinical Services Agreement No. 3167. The funders had no role in the study, data collection, analysis, decision to publish or preparation of the manuscript.