Procedure

A Carryover
Measure a high concentration blood sample 3 times, followed by measuring a low
concentration sample 3 times

B Precision
Within Run Precision
2 sample for each category:
* Each sample perform 11x continous run
Normal:
HGB
WBC
PLT
LOW:
HGB (< 7g/dL)
WBC (< 2x10^9/L)
PLT (< 50x10^9/L)
HIGH
HGB (>18g/dL)
WBC (> 50x10^9/L)
PLT (> 600x10^9/L)
Between Run Precision

3 levels of XNL Check

*Perform 4x run per day and continous for 5 days

C Correlation study
40 different patient samples are tested (analyze 8 samples per day)
within 2 hours of each analyzer

WBC (x10^9/L)
<2.0
2.0 – 5.0
5.1 – 11.0
11.1 – 50.0
>50.1

RBC ( x10^12/L)
<3.00
3.00 – 4.00
4.01 – 5.00
5.01 – 6.00
>6.01
 Hb (g/dL)
<10.0
10.0 – 12.0
12.1 – 16.0
16.1 – 18.0
18.1

PLT (x10^9/L)
<40
40 - 125
126 -300
301 - 500
500 - 600
>601

D Linerity
use Sysmex Range Check X II

E Reference Interval(verify current reference ranges)

Compare with 20 local reference samples