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Normal Laboratory Reference Values for Ugandan and Malawian Infants: A Comparison with the DAIDS Toxicity Tables
Irene Lubega*1, M Fowler1, A Elbireer1, D Bagenda1, G Kafulafula2, J Ko3, L Mipando4, M Mubiru1, N Kumwenda3, and T Taha3
1Makerere Univ Johns Hopkins Univ Res Collaboration, Kampala, Uganda; 2Coll of Med, Univ of Malawi; 3Johns Hopkins Univ Bloomberg Sch of Publ Hlth, Baltimore, MD, US; and 4Johns Hopkins-Malawi Coll of Med Res Project
Background: Normal laboratory values, particularly
hematologic, may differ by population. Use of local reference ranges for
toxicity evaluation in clinical trials is critical to accurate interpretation.
Methods: Blood samples were collected from healthy
full-term non-HIV-exposed infants from birth to 6 months of age in Uganda and Malawi. Samples were analyzed in the local research labs to establish normal reference
ranges for select chemistry and hematology parameters. Reference range values
were calculated for each age group using a nonparametric bootstrap statistical
method. Hematological values from healthy Ugandan and Malawian infants are
compared to age groups and toxicity levels used in the U.S.-based 2004 Division
of AIDS (DAIDS) Toxicity Tables.
Results:
Conclusions: Using DAIDS toxicity grading levels, 45
to 50% of healthy infants in Uganda and Malawi ≥57 days of age would
have an abnormal hemoglobin. In Malawi 67% of infants would have an abnormal absolute
neutrophil count at birth. Use of local country norms is strongly recommended
in clinical trials to avoid misinterpreting normal lab results as possible drug
toxicities.
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