L–000867(A)
5–1
5 – Performance and Limitations
Operating Ranges
Hematology parameters measured with the QBC STAR system are valid over the following range of values:
Hematocrit
15 – 65%
Hemoglobin
5.0 – 20.0 g/dL
Platelet Count
20 – 999 x 10
9
/L
WBC Count
1.6 – 99.9 x 10
9
/L
Granulocyte Count
0.8 – 70.0 x 10
9
/L
Lymph/Mono Count
0.8 – 99.9 x 10
9
/L
Results that fall outside these ranges may be confi rmed by alternate methods.
Precision
Data on typical within-run precision tests on QBC STAR tubes tested in the QBC STAR system are shown in the two tables
below. The precision data represents the analysis of ten whole blood specimens, each assayed in replicates of 10.
Whole Blood Total Imprecision
Parameter
Range
Max S. D.
GRAN (%)
38 – 79
3.2
LYMPH/MONO (%)
21 – 63
3.2
Parameter
Mean Value
Mean %CV
HCT (%)
41.7
2.0 %
HB (g/dL)
14.0
1.9 %
PLT (x 10
9
/L)
235
6.0 %
WBC (x 10
9
/L)
6.0
6.4 %
