Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials
2008

Reference Intervals for Healthy Adult Ugandan Blood Donors

Sample size: 862 publication Evidence: moderate

Author Information

Author(s): Eller Leigh Anne, Eller Michael A., Ouma Benson, Kataaha Peter, Kyabaggu Denis, Tumusiime Richard, Wandege Joseph, Sanya Ronald, Sateren Warren B., Wabwire-Mangen Fred, Kibuuka Hannah, Robb Merlin L., Michael Nelson L., de Souza Mark S.

Primary Institution: Makerere University Walter Reed Project, Kampala, Uganda

Hypothesis

What are the reference intervals for hematology and clinical chemistry parameters in healthy adult Ugandan blood donors?

Conclusion

Using local reference ranges could have significantly reduced the number of volunteers excluded from a vaccine trial due to hematologic abnormalities.

Supporting Evidence

  • 31% of volunteers screened were excluded due to hematologic abnormalities.
  • If local reference ranges had been used, 83% of those excluded could have been included.
  • The study highlights significant differences in reference ranges between Ugandan and US populations.
  • The study was conducted with ethical approval and anonymous participation.
  • The blood bank's screening process effectively reduced HIV prevalence among donors.
  • Statistically significant gender differences were observed in most hematology parameters.
  • The study provides essential data for improving clinical trial enrollment in Uganda.
  • Local reference ranges may need to be considered for evaluating vaccine safety.

Takeaway

This study found that using local health measurements for blood tests in Uganda can help more people join vaccine trials and save money.

Methodology

A reference range study was conducted using samples from healthy adult blood bank donors in Uganda, with data analyzed for hematology and clinical chemistry parameters.

Potential Biases

The gender distribution was skewed with 80% male and 20% female participants, which may affect the generalizability of the results.

Limitations

The study lacked detailed medical histories to rule out subclinical conditions and was based on a specific population.

Participant Demographics

The median age of participants was 23 years, with 73% below the age of 30; 20% were female and 80% male.

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0003919

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