COMPARABILITY OF ABSOLUTE PERCENT CD4+ T-LYMPHOCYTES COMPLETED LOCALLY AND CENTRALLY/

The Hemophilia Growth and Development Study (HGDS) is a multicenter lo ngitudinal study of 333 male children and adolescents with moderate or severe hemophilia, ranging in age from 6 to 19 at entry. Sixty-two pe rcent of the cohort was infected with human immunodeficiency virus (HI V) in the late 1970s and early 1980s through exposure to contaminated clotting factor concentrates. The HGDS has followed this cohort since 1989. HGDS subjects have blood drawn twice each year for t-lymphocyte subsets, with fresh blood shipped overnight to a central laboratory. T -lymphocyte subsets from the same blood draw are often determined loca lly as well. To evaluate interlaboratory variation, we examined the co mparability of pairs of local and central results for CD4+ absolute co unts and percents. Ninety-four pairs of absolute counts and 73 pairs o f percent CD4+ results were available. We calculated concordance corre lation coefficients, which evaluate the agreement between two readings from the sample by measuring the variation from the 45 degrees line t hrough the origin. Absolute counts were square root transformed. Compa rability of the pairs was high for both absolute counts and percents ( 0.93 and 0.92, respectively). Agreement was high whether we determined the CD4+ counts and percents centrally, using fresh samples received the day after the examination (0.95, 0.95), or from specimens that wer e frozen upon receipt and batched for later testing (0.90, 0.87). We c onclude that when a centrally processed CD4+ result is unavailable bec ause of shipping problems or loss of specimens, a study may reasonably accept a CD4+ result completed locally, if validity checks indicate g ood comparability. In the HGDS, the data provided by the local laborat ories were of comparable quality to those provided by the central labo ratories. (C) Elsevier Science Inc. 1998.