INTRODUCTION
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-23
Table 1-4: System Specifications (Continued)
Differential Accuracy The instrument differential is compared by using 100 or more fresh samples
to the reference 400 cell manual differential (200 counts with 2 Lab. Techs.),
as per NCCLS H-20A. MONO% is compared by using the monoclonal
antibodies. Results are displayed as a range of values that are the mean
differences between the methods, expressed to a 95% confidence interval.
NEUT% Coefficient correlation r ≥ 0.90
LYMPH% Coefficient correlation r ≥ 0.90
MONO% Coefficient correlation r ≥ 0.75
EO% Coefficient correlation r ≥ 0.80
BASO% Coefficient correlation r ≥ 0.50
Additionally, the mean difference from that obtained on the standard
instrument should be the following:
NEUT% within ± 3.0 NEUT%
LYMPH% within ± 3.0 LYMPH%
MONO% within ± 2.0 MONO%
EO% within ± 1.0 EO%
BASO% within ± 1.0 BASO%
Linearity
for Closed and
Open mode
WBC within ± 0.30 x 10
3
/µL or within 3%
for range 1.00-99.99 x 10
3
/µL
RBC within ± 0.03 x 10
6
/µL or within 3%
for range 0.30-9.99 x 10
6
/µL
HGB within ± 0.2 g/dL or within 2%
for range 0.1-25.0 g/dL
HCT within ± 1.0 HCT% or within 3%
for range 10.0-60.0 HCT%
PLT within ± 10 x 10
3
/µL or within 5%
for range 10-999 x 10
3
/µL
(Condition: RBC count is less than approx. 7.00 x 10
6
/µL)
Linearity
for Capillary mode
WBC within ± 0.50 x 10
3
/µL or within 5%
for range 1.00-99.99 x 10
3
/µL
RBC within ± 0.06 x 10
6
/µL or within 6%
for range 1.00-9.99 x 10
6
/µL
HGB within ± 0.7 g/dL or within 7%
for range 2.0-25.0 g/dL
HCT within ± 2.0 HCT% or within 6%
for range 10.0-60.0 HCT%
PLT within ± 20 x 10
3
/µL or within 10%
for range 10-999 x 10
3
/µL
(Condition: RBC count is less than approx. 7.00 x 10
6
/µL)
NOTE: The Linearity range is different from the Display range. Consult the
Linearity specification for the reportable range for each parameter. The
Display range is given on the next page.
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