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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We are now sending all 3.5 and above to the main lab for confirmation
coaguchek verses main lab in 1 week:
6.7/ 4.5
6.4/ 4.8
5.4/ 3.8
4.7/ 3.4
4.2/ 3.2
We have two of the new lots. We are collecting comparison data by auditing POCT results weekly and searching for any paired lab results. We have not found many, but the
results are satisfactory. The only pair with an INR>3.5 is POCT 4.0/Lab 3.8. Other pairs have a slightly negative bias of -0.1 to -0.2, although one result was -0.3 (POCT 1.5/Lab 1.8). These results are consistent with what we observe with other lot numbers,
and meet our criteria for acceptability.
This really is not a new and unusual occurrence, although it is a painful one. Other manufacturers have had this problem in the past, in at least one case leading to a recall, because the WHO reference thromboplastin changes.
As can be seen by these posts, not everyone is going to have an issue. Others may have no issue now, but will when the lab reagent changes to one that is calibrated to the '16 thromboplastin.
As I see it, the most important thing is to run some samples for a correlation to your lab to see if anything has changed. If not, count your blessings and move forward. If yes, there are still options. First, if the patient has been monitored by the same POC device over time and the results are still consistent with the patient presentation, you can opt to simply move forward as is. Most PT/INR guidelines recommned that a single system be used for each patient due to systematic differences between labs & labs, labs & POC and POC & POC.
If that makes you uncomfortable and you don't want to use the POC device, you can send everyone to the lab. Expect that initially when this change is made you will see more dose adjustments than usual due to the change in monitoring method.
If you only see the discrepancies at higher INR, change the reflex value that requires a lab result to confirm.
Train the docs/ clinic staff on the new bias between lab and POC and allow them to decide what is best for patient care.
My 2 cents.
Marcia
mlzucker.zivd@gmail.com
Marcia, ever the voice of reason! Thanks so much for your post. I'm not sure what we'll do; our medical directors don't feel we have a problem at this point, and we intermittently get emails from users about discrepancies, mostly which I believe are due to pre-analytic issues or patient diagnosis. It's difficult to separate out. I do appreciate hearing from you, especially since we never got a chance to talk at AACC!
Can someone send a link to or copy of the technical bulletin? We have a couple of clinics using the Coaguchek and we've never seen this. Ivy
At first we thought also that it was pre-analytical and even set-up observations with our seasoned coagulation nurses until we started hearing about the discrepancies from multiple sites. We then collected all the locations discrepancies and saw how far reaching this was and they were all using the affected lot numbers of test strips. We sent all this data into the Roche Technical team as requested.
Hello everyone!
Yes, indeed! A complete nightmare with the Coaguchek vs Stago, but it can be done. After doing correlations, any result >3.5 is now confirmed on the Stago. We've had patient complaints, but its for the best. This was back in April when my State inspector said our ranges were too wide. We didn't get notification from Roche, so I'm actually glad my inspector said something.
Ivy, I sent you a message. Send me an email and I'll happily share the bulletin.
jmumfor3@jhmi.edu
What instrument is the lab using?
We are using the ACL Top 500 in our main laboratory. Has anyone performed a correlation with that device (with the new strips)? I was told the Coaguchek XS does not correlate due to the reagent used in the ACL Top 500. Any input is greatly appreciated!
I just did a small correlation with our brand new ACLTop 500’s and was very happy with the results. My question is what will happen when they get calibrated to
the new WHO standards (as they’re new I’m not sure if they have been already and no one could seem to tell me).
Lab CoaguChek
1.7 1.6
>8.8 >8.0
1.8 1.7
5.6 5.4
4.4 4.4
Fingers crossed that things remain this good. Our previous point where results stopped correlating with our old Hematology analyzer was 3.5.
Lara
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I am coordinating one to begin on next Tuesday with our ACL Top 500s, at least 20 patient studies. Our current reagents are not on the new WHO Standard calibration. The next lot number will be, I am told. I'm hoping for the same results that Lara got. :)
I just wanted to follow up, we did a 50 patient study and results below 3.5 look great! We have changed our protocol accordingly.
I just received a message from our Roche sales rep and she stated that a correction memo is being sent out soon from Roche concerning the calibration change to the new WHO standards. She said the memo will state to repeat levels above 4.5. We found in our comparison studies we can trust results up to 4.0. Our rep also said that Roche will be going back to the old calibration standard and reagent strips should be available somewhere between Oct and Nov.
I have a copy of the new bulletin if anyone needs it I'm happy to email it to you directly.
Please send me an email requesting a copy at jmumfor3@jhmi.edu.
The lots that have been recalibrated to the old WHO standard should be available to customers sometime after October.
Sent via Groupsite Mobile.