CoaguChek INR - cut off range
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What are you using for the cut off range for INR results on the CoaguChek before a venipuncture is required.
We state that - INR results >4.5 should have a venipuncture performed.
Is that what others are using or another range?
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We have found that INR results < 6.0 are acceptable. A lab draw is required if ≥6.0
We use anything greater than 4.5.
Cindy Engbert MLS (ASCP)CM
Point of Care Coordinator
FHN
1045 W Stephenson St
Freeport, IL 61032
Phone: 815-599-6704
Fax: 815-599-6215
Email: lengbert@fhn.org
www.fhn.org
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e-mail message and any attached file(s) is intended for the use of the
individual or entity to which it is addressed and may contain information that
is privileged and confidential. If the
reader of this message is not the intended recipient or an agent or employee of
the intended entity, you are hereby notified that any dissemination,
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Good morning!
Anything that is greater or equal to 3.0 needs a phlebotomy draw. In our studies, we compared Coaguchek Pro vs Stago and at 3.0 is where it did not correlate well.
Thanks
Julie Brim
The Vancouver Clinic-Vancouver WA.
We use 5.0.
We first used 3.0 when we had a Stago system, now use 4.5 since we've moved to IL.
We use 4.0. Anything equal to that or above requires a blood draw.
We use 5.0. Any greater or equal to 5 requires a blood draw. We also use the CoaguChek.
We've been using cut off >4.0 for years, based on comparisons with Stago; we think our data looks better compared to IL we now have on one campus but so far haven't changed the cut off to be higher.
After correlation studies on the newly calibrated strips and the most recent formulation of strips, we chose to confirm any Coauchek XS INR > 3.5 with a venous sample sent to a reference laboratory.
The FDA recommends confirming at or above 4.5. We also have the Stago vs. CoaguChek INR issue where above 3.2 they diverge and do not compare. Our cutoff has been 5.0 but I am working with our Medical Directors to bring it to the FDA cutoff recommendation of 4.5. I'd like to have it lower, but with 10 anticoagulation Service clinics in 11 rural counties, there would be a great deal of push back and patient dissatisfaction.
Karen, where can I find that FDA recommendation? We are implementing the iSTAT assay and I have been back and forth over what to use as the cutoff.
You should use a cutoff that has been defined by the correlation with the lab. Once differences are large enough to have clinical impact, you can require further testing. It cannot be defined by a third party since they do not have knowledge of how your lab system compares to your POC system.
I was curious what the cutoff was too, so I did a little research a while back.
Below is what the FDA recommends. I posted the link to the website as well. There is a lot of good information on the website.
"We recommend using a laboratory test for confirmation when INR results are above 4.5. When the INR is greater than 4.5, the discrepancies between the INR test meter results and the laboratory test results are higher than those at lower INR ranges."
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/WarfarinINRTestMeters/ucm595962.htm