Roche's Strips Calibrated to Current WHO standard-anyone seeing issues
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We recently learned that ROCHE has recalibrated their INR test strips to new WHO standard. We are seeing significantly higher readings in results 3.5 and greater. Our anticoagulation clinics and other departments are concerned. Is anyone
else experiencing this and what have you done in regards to INR testing?
Kim Pflugradt (Kubricky) MS, BS, MLT (ASCP)
Director of Point-of-Care-Wisconsin
ACL Laboratories
8901 W Lincoln Ave | West Allis, WI 53227
O: 414.328.7508| F: 414.328.8505
| P: 414.222.9290| kim.kubricky@aurora.org
Administrative Assistant Sr. |
Joanne Burch
O: 414.328.7662
|joanne.burch@aurora.org
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While I cannot speak to this specifically (Roche recalibration), I can say that this is not unusual. In ~2009 i-STAT recalibrated and had to issue a new CLEW as part of a recall due to the changes. This is not because the POC device is faulty, it is directly due to the new WHO standard. When the lab changes to a new lot of reagent that is calibrated to a new standard similar shifts occur.
We are seeing as great as 43% difference (most ranging from 10-25%) between the CoaguChek and lab (Siemens) values-how do you explain this to the MD's and nursing-especially when they have to call patients back to tell them there dose has to be adjusted.
Kim,
I think the solution would be for the Lab's Coag. instruments to be updated to the new standard. I love it when the POCT methods provide better results than the Lab.
Unfortunately the vendors have 2 years to switch and ours has no plans to do it soon.
Hi Kim,
I was not aware of the recalibration, but I know we have seen a number for results that do not compare to our lab instruments and have been of great concern. If you have any additional information that you could share regarding the new standard and/or the recalibration, it would be greatly appreciated. I have talked with Roche technical support and not once did anyone mention the strips being recalibrated.
To be clear- I suspect that there has not been a "recalibration", simply that the newer lots of strips are being calibrated in the same manner as older lots always were, but using a new reference thromboplastin.
Analyzer Bulletin TP-00300 was released on 7/6/18. If you haven’t received it yet I’d call tech support.
Lara
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Correct-new test strips have been calibrated using the new WHO standard.
I have called Roche because we did not receive a technical bulletin on this issue and still have not received yet. Does anyone have the bulletin available that they could privately email to me so I can look it over for our Coumadin clinic? Thanks
Hello, I have a copy.
jmumfor3@jhmi.edu, send me an email and I will happily share the bulletin.
Jeanne
Thank you Jeanne for sending it to me. Much appreciated.
We had a cutoff of 4.0. Since this change was announced we lowered the cutoff to 3.5 and our correlations have been extremely concerning. We are going to have to do a full correlation to see if the instrument is accurate at all anymore. I am very surprised there is not more talk about this!
I was surprised at the number of low responses as well. Wondering if we were one of the first to get the new lot #'s?
Kim
We just started to see drastic errors a few weeks ago but the Coumadin clinic says they could have had the new lot for somewhere between 4-8 months. I wonder why Roche put out the notice so late. Is anyone collecting data? How is it looking?
Could you give an example of the correlation results that you are concerned about?