Claudia Escobar, is this a software reflex workflow?
Claudia E. Escobar, MT(ASCP) SH, national partnership technical excellence specialist, Diagnostica Stago: Yes. We have customers who use a lupus algorithm based on ISTH guidelines. We have customers at large medical centers and reference labs that have challenges. Maybe in Dr. Volod’s position of having more control over the samples she receives, she can discern which samples are acceptable to test, versus at large reference laboratories, where they don’t have that luxury. The lupus algorithm we’ve implemented is mostly with customers at reference laboratories that will have to wing it until they get abnormal results and have to figure out how they want to manage those samples. Similar to what we’ve done with Hepzyme to remove unfractionated and low-molecular-weight heparin, we have customers that choose to go Dr. Volod’s route of “No, I’m not going to test those” or “Because I’m a reference lab, I have this one sample and have to test a particular patient and use a DOAC-removal product.” The software Dr. Volod speaks of would help with stopping points or reflex testing.
At a reference lab, you have to take all comers. You don’t have a chance necessarily to educate everyone on methods and samples and so on. Kristi Smock, can you comment on this?
Kristi J. Smock, MD, professor of pathology, University of Utah School of Medicine, and medical director, hemostasis/thrombosis laboratory, ARUP Laboratories: Yes, and nor do you have access to current medication records or other relevant information. We have incorporated DOAC neutralization into our algorithm for those reasons. We now have a series of steps in the algorithm to identify and neutralize anticoagulant medications, including heparins and DOACs. We’re using DOAC-Stop.
Dr. Goodwin (University of Vermont): Regarding lupus anticoagulant testing, we have been screening for DOACs in our thrombophilia panel since 2017. Our testing algorithm starts with measuring for anti-Xa activity and thrombin time. If anti-Xa activity is detected, we add a heparin neutralizer and retest the anti-Xa activity. If it doesn’t neutralize, we look at the chart, which will often show the patient is on a direct Xa inhibitor. About 10 percent of our patients’ lupus anticoagulant testing samples contained a DOAC in 2023–2024, based on a study we did. When I speak to my clinical colleagues, they say, “It’s not a problem. So long as the results are negative, I’m good to go.” I tell them that’s not always the case. Originally the data said you get false-positives and never mentioned false-negatives, and there’s still a belief that as long as you get a negative LA, you are not at risk for having a problem or interference from the DOAC.
Dr. Smock (ARUP): Yes, that’s not true. In particular, apixaban can cause false-negatives.
Dr. Goodwin (University of Vermont): Yes. So we stop when we have a DOAC.
Madeline Wiegman, Werfen is responsible for coagulation reagent marketing in North America. What is your reaction to what has been said?
Madeline Wiegman, product manager, hemostasis reagents, North America, Werfen: This is a challenge all labs face. It’s important to have DOAC assays when they’re indicated, and those indications are changing as we’re learning more and have more patients on these different drugs.
As we look at the future of coagulation testing, labs need to implement solutions, like our Hemosil apixaban and rivaroxaban tests, to tell if a patient is on a DOAC or neutralize the effect of the DOAC. It’s important to educate laboratorians on how DOACs can impact test results and what solutions may exist.
It puts a burden on instrument and reagent suppliers because you have to educate people who may have various levels of sophistication. Ashley Sanchez, how do you as a company deal with that?
Ashley Sanchez, BS, MT(ASCP), marketing manager, hemostasis solutions, diagnostics, Siemens Healthineers: When we do talk about apixaban testing or any DOAC testing, often the responses are, “We haven’t had to do it—why do we need to now?” Education is needed because, as you said, there are different levels of sophistication in each lab. Interests differ too. Leadership might be fixed on what they’ve done in the past or staff is not educated on DOACs and do not know what to do with an assay that isn’t giving the results they expect. What do they do next if there is a DOAC onboard? Education is needed and vendors can help.
Chris Gillespie, your comment on this.
Chris Gillespie, U.S. marketing manager, HemoSonics: I agree with Ashley. As a manufacturer, we have to consider the various levels of sophistication when we design the technology. For example, the Quantra system utilizes a dashboard-style display to make it easier to interpret hemostasis tests. We believe this approach improves the clinical team communication and results in improved patient care.