ACT -C sample for Low Linearity

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I would like to reach out to see if anyone has experience with creating a sample to test for ACT-C (K) low linearity?

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As a coagulation test, ACT should be exempt from linearity specs/requirements, no?

Yes, I've created dilutions in the past for the Medtronic ACTPlus but as James pointed out, coagulation testing per CLIA do not require linearity testing due to how the assay does not measure concentration directly(functinal endpoints).

What is the goal of your study/experiment?

I am about to talk to my upper management about POCT department and regulatory changes.

If anybody is willing to share some information, can you please email me @ alma.calzadoknudson@enloe.org

* POCT Org chart – just want to know how many POCT staff (Please remove the employee name – I just need to see the configuration of the POCT staffing).
* How many POCT operators
* How many POCT Tests (Waived or Moderate Complexity)
* How many POCT instruments

Thanks for your help.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

If you are needing to meet CAP requirements for clot based testing, the CAP is very clear on ACT testing and linearity studies. In their frequently asked questions under Accreditation Resources, Checklist Requirement Q&A, All Common, Validation/Verification FAQs:

30. Do you need to perform reportable range for ACT testing or other clot based tests?  Yes. The laboratory must verify the reportable range during the initial test method validation/verification to demonstrate that the instrument can accurately achieve the upper and lower limits of the range. Analytical measurement range (AMR) verification is not required for clot-based tests after the method is initially placed in service.

Good news! This and many more topics are going to be discussed at the upcoming ADLM POCT Regional this November 4th. It will be a great opportunity to learn and grow as a POCC.
Registration is open: 2025 Point-of-Care Testing Conference | myadlm.org

See you all there.
Erika Deaton-Mohney

Also, I should have added that this can be completed by performing a heparin dilution with fresh whole blood. We were fortunate enough to have a reference method when moving to our new method for obtaining the reference method value, or known value.

I would be happy to discuss!
Erika
deatone@bronsonhg.org

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