EDAN H50 - Appendix 2 Analytical Performance; Linear Range Specifications; Background Requirements; Precision Specifications

H50/H51 Hematology Analyzer User Manual Analytical Performance
- 66 -
Appendix 2 Analytical Performance
A2.1 Linear Range
Parameter
Linear Range
Limits
r
WBC
0×10
9
/L ~10×10
9
/L
±0.3×10
9
/L
≥0.990
10.1×10
9
/L~100×10
9
/L
±4%
≥0.990
RBC
0×10
12
/L ~1. 00×10
12
/L
±0.05×10
12
/L
≥0.990
1.01×10
12
/L ~8.00×10
12
/L
±3%
≥0.990
HGB
0 g/L ~70g/L
±2 g/L
≥0.990
71g/L~250 g/L
±2%
≥0.990
PLT
0×10
9
/L ~100×10
9
/L
±10×10
9
/L
≥0.990
100×10
9
/L ~2000×10
9
/L
±5%
≥0.990
A2.2 Background
Parameter
Background/Blank Count Requirements
WBC
ʇ0.2×10
9
/L
RBC
ʇ 0.02 ×10
12
/L
HGB
ʇ 1 g/L
PLT
ʇ 10 ×10
9
/L
A2.3 Precision
Parameter
Range
Precision
WBC
3.5×10
9
/ L ~6.0u 10
9
/ L
≤3.0%
6.1u 10
9
/ L ~15.0×10
9
/ L
≤2.5%
RBC
3.5×10
12
/ L -6.5×10
12
/ L
≤1.5%
HGB
110 g/L -180 g/L
≤1.5%
PLT
100×10
9
/ L -500×10
9
/ L
≤4.0%
MCV
70 fL -120 fL
≤1.0%
HCT
35%-55%
≤ 2.0%
A2.4 Carry-over
Parameter Carry-over
WBC
ʇ0.5%
RBC
ʇ0.5%
HGB
ʇ0.6%
PLT
ʇ1%