BD FACSCalibur - Linearity

Appendix C: Performance Data 229
Linearity
Linearity for the BD FACSCalibur system was assessed using the BD Multiset
system and BD Multitest CD3/CD8/CD45/CD4 + BD Trucount reagent. The
linear range of the BD Multitest/BD Trucount reagent system was evaluated
through independent dilution of concentrated whole blood samples. The study
assessed linearity within a WBC concentration of 0.2 x 10
3
to 29.7 x 10
3
WBC/ µ L
and a lymphocyte concentration of 0.1 x 10
3
to 9.0 x 10
3
lymphocytes/µL.
Results were observed to be linear within the CD3
+
CD4
+
range, the CD3
+
CD8
+
range, and the CD3
+
range.
Lymphocyte
Subset
R Slope Intercept
Min. Abs Count
(cells/µL)
Max. Abs. Count
(cells/µL)
CD3
0.998 1.000 23.659 61 7721
CD4
0.999 0.997 16.815 34 4938
CD8
0.998 1.004 4.129 20 3731