54 CLINITEK Status+ Analyzer Operator’s Guide
Calibration & QC
Urinalysis Strip Quality Control Testing
Test negative and positive controls when you first open a new bottle.
Water should NOT be used as a negative control. Each laboratory
should establish its own goals for adequate standards of performance.
For information about control manufacturers, contact the Siemens
Customer Service Department.
Run QC tests to ensure reagent storage integrity; train new users;
confirm test performance; and when patients’ clinical conditions or
symptoms do not match the results. Also, run QC tests per your
laboratory procedures. Liquid ready-to-use controls are available. Do
not use water as a negative control. For recommendations and
technical questions, call your local technical support provideror
distributor, or visit www.siemens.com/diagnostics.
Compare QC results to the QC manufacturer’s acceptable results list. If
the QC results are not acceptable, do not test the patient samples until
you solve the problem. Repeat QC tests until you have acceptable
results.
For expected values for each analyte, see the quality control
instructions for use product insert.
hCG Cassette Quality Control Testing
Each test includes two procedural controls, which indicate that
sufficient sample was added for capillary flow to occur and the correct
procedural technique was used. If the analyzer detects a failure of
either of these two procedural controls, an error is reported and the
test must be repeated.
Run QC tests to ensure reagent storage integrity; train new users;
confirm test performance; and when patients’ clinical conditions or
symptoms do not match the results. Also, run QC tests per your
laboratory procedures. Liquid ready-to-use controls are available. Do
not use water as a negative control. For recommendations and
technical questions, call your local technical support provider, or visit
www.siemens.com/diagnostics.
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