istat ACT linearity material

HI
Attached is the linearity procedure from Abbott.

714547-01E.pdf

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!

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.

I would concur with Angie.

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.

Be careful about the AMR for coag testing. The CAP does not require this AMR verification at 2x per year, but DOES require it at Verification. This can be found in the FAQ section of the e-Solution Suite for All Common standards related to AMR.