CHAPTER 7 Quality control
Sysmex XE-5000 Instructions for Use 7-1
Revised June 2008
7. Quality control
Quality control is performed in order to monitor an
instrument's performance over time. e-CHECK(XE) is the
quality control material recommended by Sysmex to monitor
the performance of XE-5000 analyzer. As the manufacturer,
our recommendation is in accordance with the CLIA standard
of 2 levels of control, once everyday of instrument operation
or as your laboratory policy dictates. It should be noted that
for troubleshooting purposes, additional control runs may be
necessary.
7.1 Quality control materials
Use control blood.
Use e-CHECK(XE) for the control blood.
7.2 Quality control methods
There are two QC methods for the XE-5000, one using control
blood and one using normal samples.
QC using control materials
•X
control: Control blood is analyzed twice, and the
mean value of the two analysis is used to
evaluate analyzer performance.
• L-J control: Control blood is analyzed once and the result
is used as control data.
It can monitor changes over time.
QC using normal samples
•X
M control: This program calculates the summation
average of batches of samples (usually 20)
using Bull’s algorithm, and plots the resulting
value as control data.
Information
Do not use any material other than the specified
control blood. The control blood is specifically tailored
to the analysis technology employed by the
instrument.
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