From Gretchen Schaef Johns, M.D., Mayo Clinic, Jacksonville, FL: Is Ecarin available in the US and is the Ecarin clotting time (or the newer Stago Ecarin chromogenic test) research use only? Someone told me that you can’t get Ecarin in the US currently. Thanks.
Thanks for your question, Dr. Johns. As you indicate, Diagnostica Stago has developed both the Ecarin clotting time and the Ecarin chromogenic assay, both of which are described on their web site, however the assays are currently before the FDA awaiting US clearance, and are labeled research use only (RUO). The Ecarin time test is offered by several specialty reference laboratories, including Esoterix and Machaon (whose web site describes the test as under development). Stago does not routinely offer reagent Ecarin in the US, though I’ve heard that some laboratories have purchased through their European distribution system.
Alternatively, Hyphen Biomed offers the Hemoclot direct thrombin inhibitor test(dilute thrombin time test), marketed in North America by Aniara. Like the Ecarin clotting time and the Ecarin chromogenic assay, the dilute thrombin time assay is currently RUO.
This reminder arrived later on October 7, 2011 from Jeff Light of Centerchem:
Hi George, Ecarin remains available from Centerchem as a raw reagent for developing the Ecarin clotting time for in-house development. Also, very soon we plan to have FDA clearance for the Pefakit PiCT UC (uncalibrated) for measuring all anticoagulant therapy. Currently we are enrolling US study centers if any of your members could be interested.
Thank you, Jeff, I am familiar with Pefakit PiCT, even discuss it in my presentation, “Whatever Happened to the PT and PTT.” Not mentioning it here was a brain cramp, and I appreciate your reminder. Geo.