Drucker Diagnostics Paralens Advance User Manual

Page 31

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4.5.2 QBC Controls

QBC Hematology Control (p/n 424304) is available
for performance monitoring of the Autoread Plus
system. The control kit is shipped at regular
intervals and contains two levels of control material,
along with instructions for preparing and testing
control tubes and an assay sheet showing expected
results.

Good laboratory practice suggests that controls be
run to assist in monitoring the performance of the
total test system. For users in the United States,
the Clinical Laboratory Improvement Amendments
(CLIA) requires that controls be used for each day
of patient testing. For more information on CLIA
requirements, please consult www.phppo.cdc.gov/
clia/regs.

All types of QBC tubes – AccuTubes and standard
– can be tested with the control material. To test
QBC AccuTubes, use the [MODE] key to program
the analyzer to the Control mode shown opposite;
then insert the control-filled tube. Review the
instructions sent with the control to determine
which analyzer mode should be used for testing
other QBC tube types.

An eight-scan measurement and analysis procedure
occurs, identical to the display routine for QBC
blood tubes in Section 4.2.2. Control results appear
on the display panel and printout.

Refer to the instructions and assay values
supplied with the control kit for identification of the
hematology parameters and acceptable ranges to
be obtained with QBC Control.

QBC Extended Range Controls (p/n 424305) are
also available. United States users are required to
run these controls every six months to meet CLIA
requirements for calibration verification.

Extended Range Controls are available on an
as-needed basis. The kit contains 3 levels of control
material along with instructions for preparing and
testing control tubes, and an assay sheet showing
expected values.

4-8

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