Zybio Z3 - 2.7 Performance Requirements

9
Mean Corpuscular Hemoglobin Concentration
MCHC
Red Blood Cell Distribution Width Coefficient of Variation
RDW-CV
Red Blood Cell Distribution Width Standard Deviation
RDW-SD
Hematocrit
HCT
Platelet count
PLT
Mean Platelet Volume
MPV
Platelet Distribution Width
PDW
Plateletcrit
PCT
Platelet Larger Cell Ratio*
P-LCR*
Platelet Larger Cell Count*
P-LCC*
Table 2-5 Histograms
White Blood Cell Histogram
WBC Histogram
Red Blood Cell Histogram
RBC Histogram
Platelet Cell Histogram
PLT Histogram
2.7 Performance Requirements
2.7.1 Background/Blank Count
Background refers to the background count performed automatically by the analyzer during the
startup process; its result shall meet the requirements in the following table.
The blank count requirements apply to both whole blood and pre-dilute modes.
Blank count test method: run diluent on the analyzer consecutively for 3 times, the highest
value among the 3 results shall meet the requirements in the following table.
Table 2-6 Background/blank count requirements
Parameter
Background/blank count requirements
WBC
≤ 0.20×10
9
/ L
RBC
≤ 0.02×10
12
/ L
HGB
≤1 g/L
HCT
≤ 0.5 %
PLT
≤ 5×10
9
/ L
2.7.2 Carryover
Carryover refers to the transfer of blood cells from high concentration sample to low concentration sample.
Verification method:
Prepare a high concentration sample (centrifuged high value control or special high value linearity
control) which is within the range specified in Table 2-6, mix and then test it consecutively for 3
times, and the test results are i1, i2, and i3; prepare a low concentration sample (diluted low value