Clarity Platinum Operator's Manual page 20

Urine analyzer
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Clarity Platinum Urine Analyzer
OPERATOR'S MANUAL
The quality control function is designed to detect, reduce, and correct
deficiencies in a laboratory's internal process prior to the release of patient
results. Failure to conduct quality control testing or carry out QC procedures
could lead to unreliable performance of the test system, which could result
in misdiagnosis, delayed treatment, and increased costs due to retesting. It is
of great importance to ensure all results are both accurate and reliable.
Clarity Diagnostics produces Quality Control Solution Levels I and II, which
are used to perform quality control testing. For CLIA Waived settings, Clarity
Urinalysis quality controls must be tested under the following conditions:
When a new canister of strips is opened OR
100 tests have been performed OR
Test results appear to be inaccurate OR
• A new operator uses the analyzer OR
• Each new day of testing OR
• 30 days have passed since the previous QC Pass OR
• After performing maintenance or service on the analyzer.
If the QC tests do not provide the expected results, perform the
following checks:
Ensure the strips used are not past their expiration date.
Ensure the strips are fresh from a new canister.
Ensure the controls are not past their expiration date.
Repeat the test to ensure no errors were made during the test.
If QC testing still does not provide the expected results,
call Clarity Diagnostics Technical Support: (877) 485-7877,
Monday- Friday, 8am-6pm EST.
Note: For CLIA Waived settings, only the QC controls produced by Clarity
Diagnostics (CLA-UHCRL25) should be used, as the QC pass/fail criteria have
been optimized for the Clarity Platinum analyzer.
We Support Better Outcomes™
Page 17

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