Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
Evaluation of TruCount absolute-count tubes for determining CD4 and CD8 cell numbers in human immunodeficiency virus-positive adults. Site Investigators and The NIAID DAIDS New Technologies Evaluation Group [see comments]
Clin Diagn Lab Immunol. 2000 May;7(3):336-43. Unique Identifier : AIDSLINE MED/20261937 Schnizlein-Bick CT; Spritzler J; Wilkening CL; Nicholson JK; O'Gorman MR; Department of Medicine/Infectious Diseases, Indiana University; School of Medicine, Indianapolis, Indiana 46202, USA.; cschnizl@iupui.edu
Abstract:
A single-platform technology that uses an internal bead standard and three-color flow cytometry to determine CD4 and CD8 absolute counts was evaluated for reproducibility and agreement. Values obtained using TruCount absolute-count tubes were compared to those obtained using a two-color predicate methodology. Sixty specimens from human immunodeficiency virus type 1-infected donors were shipped to five laboratories. Each site also analyzed replicates of 14 human immunodeficiency virus type 1-infected local specimens at 6 h and again at 24 h. The interlaboratory variability was significantly less with TruCount (median difference in percent coefficient of variation [%CV] between the two methods was -8% and -3% for CD4 and CD8, respectively) than with the predicate method. Intralaboratory variability was smaller, with a median difference in %CV of -1% for both CD4 and CD8 with 6-h samples and -2% and -3% for CD4 and CD8, respectively, with 24-h samples. Use of TruCount for shipped samples resulted in a median CD4 count change of 7 cells (50th estimated percentile) when all laboratories and CD4 strata were combined. For on-site samples, the median CD4 count change was 10 CD4 cells for 6-h samples and 2 CD4 cells for 24-h samples. Individual site biases occurred in both directions and cancelled each other when the data were combined for all laboratories. Thus, the combined data showed a smaller change in median CD4 count than what may have occurred at an individual site. In summary, the use of TruCount decreased both the inter- and intralaboratory variability in determining absolute CD4 and CD8 counts.
Keywords: JOURNAL ARTICLE Acquired Immunodeficiency Syndrome/*DIAGNOSIS/*IMMUNOLOGY Adult CD4-CD8 Ratio/*METHODS Flow Cytometry/INSTRUMENTATION/*METHODS/STANDARDS Hematology/METHODS/STANDARDS Human *HIV-1 Laboratories, Hospital/STANDARDS Reproducibility of Results Specimen Handling Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S.
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Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
