Coagulation Correlation
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Our main lab recently transitioned to the STAGO Compact Max for coagulation testing and INR results are not correlating as well with our POCT Roche Coagucheck XS Plus. I am aware of historic difficulty of getting POCT and main lab instruments to correlate for Coag. but was wondering if anyone else had this combination of instrumentation and what their correlations look like.
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For us, the results between the Stago and the Coagucheck only correlated below 4.0
We are evaluating CoagSense to replace the CoaguChek since we moved to Stago. CoaguChek will not correlate to Stago for multiple reasons-primarily Stago has a different thromboplastin source (rabbit) than CoaguChek (human), different ISI, add to it different sample type and mechanical clot detection vs amperiometric and algorithmic calculation.
The CoagSense company had in 2/2019 approved by the FDA a similar to CoaguChek meter with one big difference to it - it is essentially a mini fibrinometer.
Karen, I would love to know how your correlations went when you finish....
Our Coaguchek/Stago only correlated to 3.0 so anything 3.0 and above is determined by venipuncture and tested on the Stago.
Julie Brim
The Vancouver Clinic
jbrim@tvc.org
We use the Roche coaguchek system. When we used the Stago instrumentation, we could only correlate to 3.5. Since we had a move to IL, we were able to correlate up to 4.3.
Has anyone had any success in correlating at the high end (>4)? Also, any suggestions in how to create a high sample up to the linearity of the coaguchek xs (>8.0) to see how this device responds?
Hi,
I tried many methods of doctoring samples but it seems to only want an actual capillary sample. I had a couple of patients in the 5-6 range that I could validate but other
than that no luck. We don’t allow our users to report any values >5.0. These samples need to be sent to the lab. Since we went LIVE with the CoaguCheks a few months ago, they have had a few patients that were high (>5.0) and I was able to check the Lab result.
It compared well with the CoaguChek result. Our Coag Division Head (Hematopathologist) was fine with my validations and the fact that >5.0 results would have a sample sent to the Lab. My sites have been 100% compliant so far with the process.
Don’t know if this helps but good luck.
Kathy Andrews
MLT, RT
Point of Care Coordinator /
Coordinatrice des Analyses Hors Laboratoire
Moncton & Miramichi Area /
Régions de Moncton et Miramichi
Horizon Health Network / Reseau de Sante Horizon
Tel: (506)-857-5315 Fax: (506) 857-5325
kathy.andrews@horizonnb.ca
“In order to succeed, we must first
believe that we can.”
Nikos Kazantzakis
From: Samantha Bree via POCT Listserv (Groupsite) [mailto:users+1226649@poct.groupsite.com]
Sent: November-14-19 5:29 PM
To: Andrews, Kathy (LAB) (HorizonNB)
Subject: [POCT Listserv] Re: Coagulation Correlation
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We also use a “chart review” process to validate our coagulation method. Trauma patients often have blood sent to the laboratory at the same time that the POC test is done.
Julie,
I did a 3-way study between the POC methods CoaguChek and CoagSense and the Lab method Stago. Our Lab switched from the IL ACL in 2017 to the the Stago. The CoaguChek compared to the ACL through the therapeutic range and to the FDA cutoff of INR 4.5, however when the Lab method switched to the Stago there was a significant high bias at the high therapeutic range and beyond.
The CoaguChek only correlated to Stago up to INR of 3.0 in our study. This result supports the scientific literature of noncomparability between these methods due to differing thromboplastin reagents and ISI. The CoagSense meter correlated to INR 4.7, above the FDA recommended Lab confirmation INR of 4.5, and above the top end of the therapeutic anticoagulated INR of 4.0.
To assess comparability between Lab and POC, we evaluate INR in the therapeutic range. INR is a calculation, not a direct measurement, so there wouldn't be linearity expected at high INR results. The CoaguChek only compares through half of the therapeutic anticoagulated range of INR 2.0-4.0 when compared to the Stago, whereas the CoagSense compares through the entire therapeutic range and above the FDA confirmation INR cutoff.
The bottom line is when you switch Lab methodology you need to assess potential impact on the point of care methods in use.
Karen
POCT INR do not correlate very well as a group. We use the Coaguchek XS, when we had Stago instrumentation it would correlate up to 3.5, with IL tops it correlates to 4.3.