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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.
Where Can I Find the Range Values for Quality Control Solutions?
Quality Control Range Cards Available (General)
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
Polymer Technology Systems, Inc.7736 Zionsville Road | Indianapolis, IN | 46268 | USA
We develop and manufacture diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions. Our products are distributed in more than 100 countries.
More Contact Info
CardioChek Test System Accepted by HEART UK for Use in Nationwide Program
PTS, Inc. Signs Agreement to Provide Point-of-Care Lipid Testing to Life Line Screening
HRA Now Available!
New Products & New Performance Data
Download Performance Data
Take the Competency Quiz
for CardioChek Analyzer
CardioChek®is FDA cleared and may be eligible for flexible spending account reimbursement.
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