SYSMEX XE-5000 - Page 222

CHAPTER 11 Technical Information
11-4 Sysmex XE-5000 Instructions for Use
Revised July 2007
Precision
(reproducibility)
Capillary mode
WBC 9.0% or less (4.0 × 10
3
/µL or more)
RBC 4.5% or less (4.00 × 10
6
/µL or more)
HGB 3.0% or less
HCT 4.5% or less
MCV 4.5% or less
MCH 4.5% or less
MCHC 4.5% or less
PLT 12.0% or less (100 × 10
3
/µL or more)
RET# 35% or less (RBC 3.00 × 10
6
/µL or more, RET% 1-4%)
RET% 35% or less (RBC 3.00 × 10
6
/µL or more, RET% 1-4%)
WBC-D 9.0% or less (4.0 × 10
3
/µL or more)
NEUT% 24.0% or less (30.0 NEUT% or more, WBC 4.0 × 10
3
/µLor more)
LYMPH% 24.0% or less (15.0 LYMPH% or more, WBC 4.0 × 10
3
/µL or more)
MONO% 60.0% or less ( 5.0 MONO% or more, WBC 4.0 × 10
3
/µL or more)
EO% 75.0% or less, or within ±4.5 EO% (WBC 4.0 × 10
3
/µL or more)
BASO% 120.0% or less, or within ±3.0 BASO%(WBC 4.0 × 10
3
/µL or more)
IG% 75.0% or less, or within ±4.5 IG%
(IG% 2.0% or more, WBC 4.0 × 10
3
/µL or more)
NRBC% 75.0% or less, or within ±4.5NRBC% (WBC 4.0 × 10
3
/µL or more)
NEUT# 24.0% or less (1.20 × 10
3
/µL or more)
LYMPH# 24.0% or less ( 0.60 × 10
3
/µL or more)
MONO# 60.0% or less ( 0.20 × 10
3
/µL or more)
EO# 75.0% or less, or within ±0.36 × 10
3
/µL
BASO# 120.0% or less, or within ±0.18 × 10
3
/µL
IG# 75.0% or less, or within ±0.36 × 10
3
/µL (IG# 0.1 × 10
3
/µL or more)
NRBC# 75.0% or less, or within ±0.36 × 10
3
/µL
Precision
(reproducibility)
Body fluid analysis
mode
WBC-BF 30% or less (CSF: 0.015 - 0.030 × 10
3
/µL, other than CSF: 0.030 - 0.050
× 10
3
/µL)
RBC-BF 40% or less, or Max-Min≤0.007 × 10
6
/µL (0.003 - 0.050 × 10
6
/µL)
Analysis parameters See “Chapter 1: 1.3 Measurement parameters”.
Accuracy (cell counts)
Manual mode,
sampler mode
WBC Within ±3% or within ±0.20 × 10
3
/µL
WBC-D Within ±3% or within ±0.20 × 10
3
/µL
RBC Within ±2% or within ±0.03 × 10
6
/µL
PLT Within ±5% or within ±10 × 10
3
/µL
Accuracy (cell counts)
Capillary mode
WBC Within ±10%
WBC-D Within ±10%
RBC Within ±8%
PLT Within ±8%
Note:
Typical performance characteristics for precision (reproducibility) of body fluid analysis mode were
determined during instrument evaluation on a typical instrument, using 14 body fluid samples, counted
10 times consecutively in the body fluid mode and based on the precision profile.
WBC-BF Reproducibility C.V.25% or less (0.010 – 0.015 × 10
3
/µL)
Reproducibility C.V.20% or less (0.016 – 0.025 × 10
3
/µL)
Reproducibility C.V.15% or less (0.026 – 0.050 × 10
3
/µL)
Reproducibility C.V.10% or less (0.050 × 10
3
/µL or more)