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Heparin Brill-Edwards Curve Calibrators?

Steve Duff, co-CEO of Precision BioLogic received this question from a subscriber:

Has Precision ever considered producing a set of 30 plasmas containing varying levels of unfractionated heparin? I think there is a strong need for a commercial product that can be used to fulfill the CAP requirement for heparin therapeutic range development. It is a struggle for the smaller labs, such as those in community hospitals, to find 30–40 samples that meet the criteria. They may see 2–3 patients a year on unfractionated heparin, but are required to find 30–40 samples from patients on unfractionated therapy, with no concomitant warfarin. These are currently needed during initial installation of an analyzer, and every year when they change lot numbers of PTT reagent, so it would be an ongoing demand.

Steve replies, “What you are describing is the ‘holy grail’ that we’ve been chasing for decades. We envisioned a set of 30 samples (ex vivo) on UFH therapy which would have anti-Xa values assigned. The lab would then simply perform PTTs on the set, go online and input their PTT results and the lot number for the set. Software would immediately calculate and spit out their Brill-Edwards curve with the PTT therapeutic range in seconds.

The challenge (as I’m sure you have suspected) is getting a sufficient volume of plasma from individuals on UFH. Typically, we receive plasma via apheresis procedures on “healthy individuals.” It is virtually impossible to have someone on UFH cleared as a healthy individual by the medical director of an apheresis centre since UFH is nearly always tied to a previous event.

Any ideas here? We’d pursue this with vigour if we could see a path forward to UFH source plasma.

[This seems like a timely discussion given the majority of those answering this month’s Quick Question are routinely preparing Brill-Edwards curves.]

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