FDA Public Workshop on POC PT/INR

The US Food and Drug administraion will offer a public workshop, “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy,” March 18, 2016 at their White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD.

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Anticoagulant Therapy

Jan 23 2016

george

FDA Public Workshop on DOACs

The US Food and Drug Administration has released the full transcript and video recordings of their October 26, 2015 all day public workshop, “In Vitro Diagnostic Testing for Direct Oral Anticoagulants.” The workshop features Frederick Korley, Adam Cuker, Dorothy Adcock-Funk, Robert Gosselin, Stephan Moll, and several FDA representatives. Here is the transcript: /sites/default/files/doac_testing_fda_transcript_10-26-15.pdf

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Anticoagulant Therapy

Jan 15 2016

george

A VWD Treatment Oddity

A colleague told George about what seems like an unusual subtype 2A von Willebrand disease case. When treating with Humate P, the VWF antigen (VWF:Ag) level rises as expected, however the VWF ristocetin cofactor (VWF:RCo) activity level consistently hovers at 20–30%. Those are all the facts available. Could this be a VWF inhibitor specific for […]

Bleeding Disorders

ISTH SSC Call for Abstracts

On behalf of the ISTH: Hello, As a related society of the ISTH, I wanted to personally share the announcement below with you regarding the abstract deadline for the ISTH 62nd Annual Scientific and Standardization Committee (SSC) Meeting in Montpellier, France. The deadline for abstract submission is February 1, 2016. Abstract submission is free. If […]

Events

Arterial Thrombosis Profile

From Kelly Townsend, Tricore Laboratories, Albuquerque: We recently had a compliance audit and our consultant suggested that we should offer two separate panels for thrombotic risk; one for arterial and one for venous. Are other labs offering two different hypercoagulable panels? Thank you, Kelly. Participants, when you answer, please list the assays you offer as […]

Thrombophilia

Switching From Rivaroxaban to Heparin

We’ve widely acknowledged that the anti-Xa assay, currently employed to monitor heparin therapy, may be readily adapted to measuring direct oral anti-Xa antthrombotics, and at least three hemostasis diagnostics manufacturers have developed and validated rivaroxaban and apixaban calibrators and controls for this purpose. These await US FDA clearance. Meanwhile, we estimate oral anti-Xa antithrombotic efficacy […]

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Anticoagulant Therapy

Jan 12 2016

george

Elevated Protein C Activity

From colleague and friend Kelly Townsend, Tricore Laboratories, Albuquerque: We periodically see elevated protein C activity results in our rheumatology patients. We’ve been wondering what might be leading to this finding. They do not all have positive LA, and in fact tend to have PTT‘s in the lower half of the reference interval (sometimes quite […]

Lupus Anticoagulant

Mixing Studies and the Rosner Index

Here is another excellent question from Sheila Minor: We use the Rosner index for both interpretation of a PT or PTT mixing study and for LA testing, in which we follow up the DRVVT confirm and ratio with a 50:50 DRVVT mix to resolve discrepancies. Most references state that a Rosner index value of 15 or […]

Lupus Anticoagulant

APCR Controls

From Sheila Minor: We are currently using the Chromogenix Coatest APC Resistance VS kit for APCR testing. Chromogenix provides 1 set of level 1 and level 2 controls in each kit. The instructions state that the controls may be refrozen one time at –20 C or colder in their original vials. That would be fine if we used […]

Thrombophilia

Platelet Count on Spun Blue-top

From Tiffany Jones, Orlando Health: I was wondering if you could clarify for me why we can’t use a blue citrate tube for a platelet count after it has been spun once. Are there any studies to back up this reason? My facility seems to get a fair amount of patients displaying EDTA-induced platelet clumping […]

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Specimen Management

All Posts

FDA Public Workshop on POC PT/INR

FDA Public Workshop on DOACs

A VWD Treatment Oddity

ISTH SSC Call for Abstracts

Arterial Thrombosis Profile

Switching From Rivaroxaban to Heparin

Elevated Protein C Activity

Mixing Studies and the Rosner Index

APCR Controls

Platelet Count on Spun Blue-top

George Fritsma MS MLS

Cheat Sheets from George

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