Roche's Strips Calibrated to Current WHO standard-anyone seeing issues

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

 

 

cid:image001.jpg@01D0F61B.86844670

www.acllaboratories.com

 

 

Replies to this Topic

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. 

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