Quidel Triage D-Dimer QC

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Hi all,

Our freestanding emergency department runs external liquid quality control on their Triage D-Dimer every 8 hours of patient testing (the QC Device is run daily). This is a policy in place since before my time, and the testing personnel are questioning why is has to be run so often. Quidel agrees with the testing personnel that this is excessive. Before I change the policy, I wanted to see what other peers do?

Triage MeterPro Manual (Rev. A 2018/3): Based on the current CLIA guidelines and other regulating bodies, Quidel makes the following QC recommendations: Run two levels of external liquid QC with each new lot of reagents and once every thirty days with continued use of the same reagent lot number. The QC Device should be run daily.

Triage D-Dimer Product Insert (Rev C. 2020/05), they recommend the same as above but also mention "Users should follow government guidelines and/or accreditation requirements for quality control."


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We are also using the Triage for D-dimer. We did an IQCP, and run QC monthly and with new lot/shipment. 

Thank you, Kathleen! Do you mind sharing more info about your IQCP development? I'm new to POCT and this would be my first IQCP to implement on my own. I saw the CMS Guide to Developing an IQCP and it seems intense. But perhaps I'm thinking too much into it. 

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Joy Truong
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