ACT

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Is anyone doing linearity for Activated clotting time ? Is there a requirement / Standard ?

Thank you,
Dimitrinka Yancheff

7 Replies

Deanna Bogner

Wed Jul 16, 2025 at 10:34AM

ACT is not linear.

Erika Deaton-Mohney BS, MT(ASCP), CPP

Wed Jul 16, 2025 at 10:46AM

I can only speak to our testing and to our accreditation agency, CAP. After the initial verification study, the laboratory is not required to perform AMR verification for clot-based tests. It is best to connect with our accreditation agency and request specifics.

Tori Nemitz

Wed Jul 16, 2025 at 10:48AM

ACT on which instrument? Istat, no. Medtronic HMS yes we do a linearity every 6 months per our IQCP.

Tori Nemitz

Wed Jul 16, 2025 at 10:49AM

To Erika's point though, it is not a requirement and generally not done.

Kathleen David

Wed Jul 16, 2025 at 11:06AM

Clot-based tests do not need to have linearity assessed; they will not be linear. You can do a dose-response curve to prove accuracy, where increasing amounts of heparin are added to the whole blood sample and tested on the device, but this is not the same as linearity.

Alma Knudson

Wed Jul 16, 2025 at 12:41PM

No requirement for linearity if the unit of measure is TIME – “SECONDS”.

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
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Miranda Cotter

Mon Jul 21, 2025 at 11:53AM

We perform the ACT Heparin Linearity Procedure on our ISTATs when new ISTATs are validated. We only do this for initial validation and not any 6 month studies.

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