Quality Control

Always investing in quality improvements, Polymer Technology Systems, Inc., the makers of the FDA-cleared CardioChek^® home cholesterol test system consistently invest in analyzer technology, manufacturing equipment and processes, QA/QC equipment, and of course, our employees. Our interest in quality doesn't end once our product leaves the shelf. To be sure our products are always performing at peak level, we even provide quality control solutions.  And in order to continue making improvements in our products and services, we solicit and listen to your feedback.

Quality Control - What Quality Control Solutions Should I Use?

Two types of control solutions are available:

 Multi-Chemistry Controls. Catalog No. 0721

 HDL Controls. Catalog No. 0722

For use with CardioChek HDL Cholesterol test strips

Two vials: Level 1 and Level 2, one vial of each

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 the specified range, the system is working satisfactorily. If not, the test should be repeated or PTS, Inc. Customer Care should be called. It is recommended practice to test controls before testing your blood to ensure best quality results.

Turn on the CardioChek analyzer.
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, Inc. Customer Care.

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Where Can I Find the Range Values for Quality Control Solutions?

Quality Control Range Cards Available (General)

 HDL Control Range Card

 HDL Control Range Card

Quality Control Range Cards Available (Lot-Specific)

Multi-Chemistry Control Range Card (Lot-Specific)

 Multi-Chemistry Control Range Card: Lot MC11

 Multi-Chemistry Control Range Card: Lot MC12

Multi-Chemistry Control Range Card: Lot MC13

 Multi-Chemistry Control Range Card: Lot MC14

 Multi-Chemistry Control Range Card: Lot MC15

HDL Control Range Card (Lot-Specific)

 HDL Control Range Card: Lot HC12

 HDL Control Range Card: Lot HC13

 HDL Control Range Card: Lot HC14

 HDL Control Range Card: Lot HC15

 HDL Control Range Card: Lot HC16

How can I set my own ranges using PTS Panels liquid controls?

Setting Ranges for PTS Panels Liquid Controls

ChekMate Quality Control Kit Ranges

This newly designed quality control kit contains 4 specially-configured check strips and 2 MEMo Chips^® which allow the user to test up to two devices simultaneously to verify proper performance. This product provides assurance of the optimal functioning of each device testing “window,” and is positioned to complement current PTS Panels^® liquid controls to verify daily system performance and document compliance with quality standards. Using this product as part of a complete quality control program provides the added benefit of reducing the need to consume test strips by running liquid controls. For ranges and a record sheet, click on the PDF link.

ChekMate Quality Control Sheet

ChekMate Quality Control Sheet: Editable

Establishing Ranges for ChekMate

ChekMate Quality Control Range Cards Available (Batch-Specific)

ChekMate Range Card: Batch 0860-06513-01

 ChekMate Range Card Batch 0860-09213-01

 ChekMate Range Card Batch 0860-12013-01