QBC Diagnostics Star - 5 Performance and Limitations; Operating Ranges; Precision

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 %