CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa
2009

Reference Intervals for Healthy Adults in Eastern and Southern Africa

Sample size: 2105 publication Evidence: high

Author Information

Author(s): Karita Etienne, Ketter Nzeera, Price Matt A., Kayitenkore Kayitesi, Kaleebu Pontiano, Nanvubya Annet, Anzala Omu, Jaoko Walter, Mutua Gaudensia, Ruzagira Eugene, Mulenga Joseph, Sanders Eduard J., Mwangome Mary, Allen Susan, Bwanika Agnes, Bahemuka Ubaldo, Awuondo Ken, Omosa Gloria, Farah Bashir, Amornkul Pauli, Birungi Josephine, Yates Sarah, Stoll-Johnson Lisa, Gilmour Jill, Stevens Gwynn, Shutes Erin, Manigart Olivier, Hughes Peter, Dally Len, Scott Janet, Stevens Wendy, Fast Pat, Kamali Anatoli

Hypothesis

Can locally derived clinical laboratory reference intervals improve the assessment of healthy African adults in clinical trials?

Conclusion

Locally appropriate reference ranges should be used to improve the scientific validity of clinical trials in Africa.

Supporting Evidence

  • 2,990 potential volunteers were screened, and 2,105 were included in the analysis.
  • Significant gender and regional differences were observed in hematology and biochemistry values.
  • 35.3% of volunteers had grade one or higher results when graded against U.S.-derived criteria.

Takeaway

This study found that healthy adults in Africa have different blood test results than those from other countries, so doctors should use local numbers when checking health.

Methodology

A cross-sectional study was conducted at seven clinical centers in four African countries, screening 2,990 potential volunteers and analyzing data from 2,105 healthy adults.

Potential Biases

Potential selection bias as participants were recruited from those willing to participate in HIV-related research.

Limitations

The study may not be generalizable to all African populations due to selection bias and regional differences.

Participant Demographics

The final analysis cohort included 1,083 men and 1,022 women aged 18-59 years, with varying education levels and health backgrounds.

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0004401

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