Comparability of absolute/percent CD4+ T-lymphocytes completed locally and centrally

Sharyne M. Donfield, Elizabeth M. Mahoney, Margaret A. Maeder, Sarah M. Hawk, Patricia A. Sirois, Sunny K. Pearson, Ilene A. Goldberg, Sharon K. Richard, Kelly A. Baird-Cox, Lauren N. Hoel, Valerie A. Cool

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1 Scopus citations

Abstract

The Hemophilia Growth and Development Study (HGDS) is a multicenter longitudinal study of 333 male children and adolescents with moderate or severe hemophilia, ranging in age from 6 to 19 at entry. Sixty-two percent of the cohort was infected with human immunodeficiency virus (HIV) 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 locally as well. To evaluate interlaboratory variation, we examined the comparability of pairs of local and central results for CD4+ absolute counts and percents. Ninety-four pairs of absolute counts and 73 pairs of percent CD4+ results were available. We calculated concordance correlation coefficients, which evaluate the agreement between two readings from the sample by measuring the variation from the 45°line through the origin. Absolute counts were square root transformed. Comparability 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 were frozen upon receipt and batched for later testing (0.90, 0.87). We conclude that when a centrally processed CD4+ result is unavailable because of shipping problems or loss of specimens, a study may reasonably accept a CD4+ result completed locally, if validity checks indicate good comparability. In the HGDS, the data provided by the local laboratories were of comparable quality to those provided by the central laboratories. Copyright (C) 1998 Elsevier Science Inc.

Original languageEnglish (US)
Pages (from-to)451-460
Number of pages10
JournalControlled Clinical Trials
Volume19
Issue number5
DOIs
StatePublished - Oct 1 1998

Keywords

  • CD4+ comparability
  • Central laboratory
  • Interlaboratory variation

ASJC Scopus subject areas

  • Pharmacology

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    Donfield, S. M., Mahoney, E. M., Maeder, M. A., Hawk, S. M., Sirois, P. A., Pearson, S. K., Goldberg, I. A., Richard, S. K., Baird-Cox, K. A., Hoel, L. N., & Cool, V. A. (1998). Comparability of absolute/percent CD4+ T-lymphocytes completed locally and centrally. Controlled Clinical Trials, 19(5), 451-460. https://doi.org/10.1016/S0197-2456(98)00035-X