Coaguchek XS Pro Method comparisons
Hi everyone,
We currently use the Coaguchek XS Pro moderate complex handheld device for monitoring warfarin therapy at our anti-coag clinics.
Every six months I'm required to run a Method comparison where the Coaguchek user does a capillary fingerstick on a patient then has the patient drawn for a blue top and sent to the lab for testing on the Stago STA compact.
The problem arises when the Coaguchek INR is greater than 2.8 it is not comparing with the STA compact in the main lab. I follow the CLIA requirement for method comparison of +/- 0.5 INR.
I called Roche about this and they said it doesn't compare well unless you compare it to a coag analyzer that uses Dade Innovin. The Stago compact we use in the main lab uses a different PT reagent.
Does anyone else use the Coaguchek XS Pro? What do you do for Joint commission requirements when it comes to method comparison?
Thanks,
Jake
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Hi Jake,
I'm sorry I can't help you with a resolution to your question since we use the xs not the pro, so waived complexity although same strip/methodology.
I thought the comparison we did had a better correlation using the Stago Evolution so pulled up the abstract which got accepted for an anticoag conference poster. It won't make you feel any better but it reiterates during a formal supported study what the correlation was for us matched what you are experiencing.
Just an FYI shared - and I hope someone else can help you with the xs pro method comparison. Best wishes, Peggy
Taken from abstract - presented by anticoag RN at an anticoag conference (I've lost track if this was or was not accepted for publication so I can't attach the study data):
In this study the difference in patient INR values as measured by the POCT CoaguChek XS device and central laboratory Stago Evolution and Siemens BCS XP analyzers was examined. This study, composed of 100 warfarin therapy patients and 20 coagulation normal subjects, showed that the difference between the POCT and clinical laboratory values increased with increasing INR and was exacerbated by the use of different thromboplastin reagents by the POCT and central lab. The CoaguChek XS and on-site Stago analyzers which used human recombinant (ISI = 1.01) and rabbit brain thromboplastin (ISI = 1.25), respectively, showed reasonable agreement for INR < 3.0 (kappa = 0.62) but significant difference for INR ≥ 3.0 (kappa = 0.10). In contrast, the CoaguChek XS and Siemens BCS XP, which both employed human recombinant thromboplastin (BCS ISI = 1.02), showed greater agreement for the complete range INR values (INR < 3.0 kappa = 0.84; INR ≥ 3.0 kappa = 0.70). ECAA Poller calibrant data showed the automated instruments were performing as expected, indicating that ISI calibrations were correct but insufficient to standardize the INR values for the different thromboplastin methods across the full range of measured INRs.
Try this:
https://www.westgard.com/guest11.htm#waived