istat ACT linearity material

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We will soon be implementing the i-STAT and will initially be performing only ACT Kaolin and ACT Celite testing. Since the i-STAT ACT methodology is not clot-based, CAP requires us to perform linearity studies at implementation and every six months thereafter.

Does anyone have a recommendation for linearity material they are currently using for i-STAT ACT testing? The only product I have found so far is Eurotrol CueSee Coag. However, the material is unassayed, so we would need to establish our own target values.

I would appreciate any recommendations or feedback on products that have worked well for your laboratory.
Deborah Martuch, MLS(ASCP)
deborah.martuch@hf.org

5 Replies

Amanda Casavant

Wed Sep 23, 2026 at 1:17PM

HI
Attached is the linearity procedure from Abbott.

714547-01E.pdf

Angie Yost

Wed Sep 23, 2026 at 1:32PM

Hi Deborah! When you say linearity studies, are you talking about AMR verification and/or calibration verification? In POC.08300, there is a note at the very end that says "Single use devices, and other test devices that do not allow user calibration, do not require calibration verification". The i-Stat does not allow user calibration. For AMR verification, POC.08600 states "AMR verification is not required for clot-based coagulation tests, platelet function tests, and
other tests where output is a unit of time or arbitrary reporting unit (rather than measured analyte concentration)". The i-Stat ACT-C is reporting a unit of time (seconds) so I don't think AMR verification is required. Curious to hear what others have to say!

Miranda Cotter

Wed Sep 23, 2026 at 3:25PM

We perform the Heparin Linearity procedure upon initial validation of a new ISTAT analyzer only. We do not perform that at every 6 months due to POC.08600.

James Beck

Wed Sep 23, 2026 at 3:55PM

I would concur with Angie.

Mandye Canales

Wed Sep 23, 2026 at 5:43PM

CAP doesn't require AMR for coag testing based on the guideline. Sorry, I don't have it in front of me but I can follow up if you like. Also, Abbott may have a validation plan to follow and should provide some guidance in that document. I have seen them for blood gases and troponin. They are helpful in providing support. CAP is also very helpful in interpreting their guidelines. Let me know if I can help further.

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Topic	Replies	Likes	Views	Participants	Last Reply
istat ACT linearity material Deborah Martuch, MLS(ASCP), CPP about 5 hours ago	5	0	299	+ 2 more	Mandye Canales 28 minutes ago
Advice Needed Regarding GEM 100 Result Documentation Melva Anderson about 12 hours ago	6	0	251	+ 3 more	Melva Anderson about 6 hours ago
Venous Blood Gas Worklfow Sarah Spaulding 1 day ago	5	1	304	+ 2 more	Harvey Hveem about 4 hours ago

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istat ACT linearity material