226 BD FACSCalibur Instructions for Use
Accuracy
Lymphocyte subset percentage and absolute count enumerations with
BD Multitest CD3/CD16+56/CD45/CD19 in BD Trucount Tubes were compared
with results from BD Tritest CD3/CD16+56/CD45 or CD3/CD19/CD45 in
BD Trucount Tubes.
Whole blood samples from normal and abnormal donors were collected at
random at two clinical laboratories and evaluated in both systems. Regression
statistics reported in Table C-1 indicate that the results are substantially
equivalent.
Table C-1 Regression Analysis
Subset n R Slope Intercept Range
Natural killer
lymphocytes (%)
126 0.97 0.97 –0.85 3–40.0
B lymphocytes (%) 126 0.99 0.98 –0.25 0–59
T lymphocytes (%) 126 0.99 0.99 1.74 21.5–90.0
Natural killer
lymphocytes (cells/μL)
126 0.96 0.92 –5.44 37–901
B lymphocytes
(cells/μL)
126 0.98 0.95 1.77 3–877.6
T lymphocytes
(cells/μL)
126 0.98 1.01 –10.18 100–2883
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