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Quality Control
CardioChek Systems - Analyzers, PTS Panels Test Strips and MEMo Chips - are designed to ensure accurate blood chemistry results are reported. To ensure the entire system is functioning properly, Quality Control Solutions ("controls") should be used.
Click on the questions below for more information:
What are Quality Control Solutions?
What Control Tests Should Be Run?
What Quality Control Solutions Should I Use?
What Is the Recommended Procedure for Using Quality Control Solutions?
Where do I Find the Range Values for my Quality Control Solutions?
How do I Find Control Ranges on this Website?
CardioChek Quality Control Solutions are specially manufactured for CardioChek Systems to test that the system (analyzer, strip and MEMo chip) is working properly. When a drop of control solution is applied to a Test Strip and analyzed, a test result is displayed. If the displayed result falls within a range of values established by PTS laboratory testing, the user can be assured that the CardioChek System is working properly. Users are encouraged to establish control ranges for their laboratory.
Controls should be used to test system performance at two medical decision levels, thereby ensuring that when blood is used, the system is functioning properly across the clinical range.
PTS recommends users test both Level 1 and Level 2 control levels with each new lot of test strips, and not less than once per month. Clinical laboratories should perform Quality Control testing that complies with the policies of their facility. Facility policies are established to meet regulations required by their CLIA or other laboratory license.
Two types of control solutions are available:
Multi-Chemistry Controls. Catalog No. 0721.
- For use with Total Cholesterol, Triglycerides, Glucose, Ketone and Lipid Panel (Cholesterol and Triglycerides) test strips.
- Two vials: Level 1 and Level 2, one vial of each.
- For use with HDL Cholesterol and Lipid Panel (HDL) test strips.
- Two vials: Level 1 and Level 2, one vial of each.
Overview: Quality control solutions are tested on a Test Strip in the same manner a blood sample
would be run. A drop of control solution (instead of a drop of blood) is applied to the strip.
In 1-2 minutes, the CardioChek analyzer will display a result. If the result falls within a specified
range, the system is working satisfactorily. If not, the test should be repeated or PTS Customer
Service should be called.
Detail:
- Turn on the CardioChek PlA
- Insert the MEMo Chip for the lot of PTS Panels Test Strips you are using.
- Press the Enter button. (The analyzer will
display RUN TEST).
- Press the Next
button twice to scroll to UTILITY.
- Press the Enter button. (The analyzer will
display CK STRIP).
- Press the Next button once. (The analyzer will
display RUN CONTROL).
- Press the Enter button. (The analyzer will
display the lot number for the MEMo Chip and Test Strip. Then it will display INSERT STRIP).
- Insert a Test Strip. (The analyzer will then display APPLY CONTROL).
- Dispense one drop from the Level 1 Control vial. (The analyzer will display CONTROL, and after about two minutes will display the control result).
- Record the result.
- Compare the displayed result to the range of values established for the lot of strips with the lot of controls being used.
- Remove the Test Strip.
- Repeat steps 7-10 with the Level 2 Control.
- If both the High and Low results fall within the acceptable ranges, the system is functioning properly. If not, clean analyzer, check that correct MEMo chip and test strip combination are being used and repeat the test. If the results fail to fall within range the second time, call PTS Customer Service.
- Each package of multi-level or HDL controls contains a "Range Card" for all unexpired
lots of test strips. Simply find the lot number for the controls you
have, and read the appropriate High and Low range values.
OR
- Website. Find control values for all unexpired test strips and unexpired control
solutions on this website.
OR
- PTS Customer Service.
Lot numbers for the Level 1 and Level 2 Control Solutions should be different numbers. Please select a different lot number for one of the Control Solutions.