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D-dimer Lot-to-lot QC


I attended your session on coagulation problems at the NW Medical Lab Symposium. Thank you for a great presentation and for putting the symposium information on your website.

I would like to know what protocol you use for checking out new lots of D-dimer reagent. We use the Siemens Stratus for D- dimer and they recommend a control by Innovance. There used to be product insert information about target QC ranges for each lot of reagent but they’ve stopped providing it.

We are a STAT lab in a clinic, so our patient volume is fairly low. We’ve been running 4 or 5 patients on the old and new lots of reagent and they generally agree well. We’re not sure how many QC data points we need to establish the new range and usually call Siemens to get peer data to set the range. Any recommendations you have would be appreciated.

Do I need to register on your website to receive an answer?

Thanks again for speaking at our meeting. I hope you enjoyed your visit.

Toni Okada, MLS, (ASCP), Lab Manager
Laboratory Services, Group Health Cooperative
Bellevue Medical Center

Hi, Toni, I am glad you were able to attend the Top Ten talk in Seattle (Lynnwood) and thank you for your compliment and your question. No, you don’t need to register on the site to receive your answer, however you may wish to register to append comments to recent posts and to receive our monthly cheat sheet.

I don’t have a satisfactory answer, though as you remember from the Top Ten presentation, there is a strong need for normalizing the D-dimer assay. I am surprised that the Innovance material no longer provides targets, and have contacted a Siemens representative for follow-up on the question. I checked with Cari Reed at UAB, and like many, UAB uses the controls provided in the kit, which automatically check calibration when placed on the instrument. We are using Diagnostica Stago’s materials. I’ve also checked with several plasma suppliers, and have not found a D-dimer calibration/QC control set. By posting the question, we may hear from someone who can provide some answers on lot-to-lot D-dimer management.

Comments (3)
Oct 26, 2018 9:02am

I have been getting dizzy
I have been getting dizzy when I stand up and my calves burn and cramp. When I bend over I get short of breath to the point that it feels like I ran miles. If I stand in one place within a minute my calves burn and cramp horribly. My Dr did a D Dimer and it was 8500, he rushed me in for a CT Scan Angiogram and my lungs are great, I just went for a Brain MRI, showed perfect brain, checked my heart, came out good. My thyroid is fine. He wants me to start on prednisone. My sed rate is also high 69. So he thinks I have an inflammation but he can’t find anything wrong in additional testing. I want him to check my legs, but will find out today if he will do that. I do have cirrhosis in my liver from HCV. I did the Harvoni treatment from March to June 2018 and it now is not detected. My Dr doesn’t know if the D Dimer and/or Sed Rate is elevated because of the treatment and/or the cirrhosis. I don’t know to panic or this isn’t something to panic about.

Mar 5, 2012 5:05am

Our lab is using the Innovance D-dimer reagent and control;
Our lab is using the Innovance D-dimer reagent and control; Innovance D-dimer reagent and control are approved to be used by Siemens Stratus. The product insert has information about target QC ranges for each lot of reagent. good luck.

Hematology Supervisor
Dept of Pathology; Laboratory Medicine

Oct 25, 2011 12:26pm

Hi Toni,
My laboratory is using the Liatest D-Dimer by Diag

Hi Toni,
My laboratory is using the Liatest D-Dimer by Diagnostica Stago on a STAR Evolution. When we switch lots of reagent, I run 15-20 plasmas that I have collected from volunteer co-workers that are deemed hemostatically normal via questionnaire. I typically will do a “normal range request” at least once during the year. I can then validate my cut-off value using a local population. As far as QC, we do run at least 30 points of each of 2 levels to be included in a peer group with Stago. Because D-Dimer is going to be such a bear to standardize, I imagine a commercial set may not be a sure thing. Good luck!
Crystal Azevedo, MT(ASCP)SH
Lead technologist, Coagulation Department
Affiliated Laboratory, Inc.
Bangor, Maine

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