Zybio Z3 - Linearity

11
Table 2-9 Whole Blood Repeatability Requirements
Parameter
Condition
Whole Blood Repeatability
(CV/absolute deviation d)
Pre-dilute Repeatability
(CV/absolute deviation d)
WBC
7.0～15.00×10
9
/ L
≤2.0％
≤4.0％
4.0 ~ 6.9×10
9
/ L
≤ 3.5
RBC
3.50 ~ 6.50×10
12
/ L
≤1.5%
≤2.0%
HGB
100 ~ 180 g/L
≤1.5%
≤2.0%
MCV
70.0～110.0 fL
≤1.0%
≤1.5%
PLT
100 ~ 149×10
9
/ L
≤5.0%
≤8.0%
150 ~ 500×10
9
/ L
≤4.0%
HCT
30～50%
/
≤ 2.5
MPV
-
≤4.0%
≤5.0%
2.7.4 Linearity
Linearity was determined by running diluted samples. Samples of different concentrations were
tested in both whole blood and pre-dilute modes; the slope and intercept were calculated per the
linear regression equation, and then the deviation between the theoretical value and test result was
obtained, which shall meet the requirements in the following table.
Table 2-10 Linearity Requirements
Para
meter
Linearity Range
Deviation Range
(Whole Blood)
Deviation Range
(Pre-dilute)
WBC
0.0～100.0×10
9
/L
±0.30×10
9
/L or 5％
±0.50×10
9
/L or 5％
100.1～200.0×10
9
/L
±9％
±18%
RBC
0.0～8.00×10
12
/L
±0.05 ×10
12
/L or
±5％
±0.05 ×10
12
/L or
±5％
HGB
0～280 g/L
±2g/L or ±2％
±2g/L or ±3％
PLT
0～1000×10
9
/L
±10×109/L or ±10%
±10×109/L or ±10%
1001 ~ 4000×10
9
/L
±12%
±20%
HCT
0~67%
±4% (HCT value) or
±6% (deviation
percent)
/
Note: The linearity ranges above are expressed in both absolute deviation and deviation percent, meeting
either of the ranges are OK.