Mindray BC-20s - Page 20

Product Specifications
2-5
consecutively for 3 times, and the test results are i1, i2, and i3; prepare a low concentration
sample (diluted low value control, dilution ratio: 1:10) which is within the range specified in
Table 2-6, test it consecutively for 3 times, and the test results are j1, j2, and j3. Calculate the
carryover according to the following equation, and the result shall meet the requirements in
Table 2-5.
Table 2-5 Carryover Requirements
Parameter Carryover
WBC
≤0.5％
RBC
≤0.5％
HGB
≤0.6%
PLT
≤1.0%
Table 2-6 Sample Concentration Range of Carryover Test
Parameter Unit High concentration range Low concentration range
WBC
×10
9
/L
> 15.00 < 3.00
RBC
×10
12
/L
> 6.00 < 1.50
HGB g/L > 200 < 50
PLT
×10
9
/L
> 300 < 30
2.7.3 Repeatability
Test a sample which meets repeatability requirement on the analyzer consecutively for 10 times,
calculate the CV(%) and absolute deviation (d) of each parameter, and the results shall meet the
requirements in the following table.
In the equation:
s
----standard deviation of sample test results;
x
----mean value of sample test results;
i
x
----actual test result of the sample;
d
----absolute deviation of the sample test results.
Table 2-7 Whole Blood Repeatability Requirements