Dabigatran is the active component of the oral anticoagulant prodrug, Dabigatran Etexilate and in specific situations or in emergency situations warrants monitoring.

Aniara Diagnostica LLC offers Dabigatran Plasma Calibrators (A222801) and Control Plasma (A224701) to be used in conjunction with the Hemoclot Thrombin Inhibitor Kit (ACK002K and ACK002L) to assist the laboratory in the set up of the dabigatran assay. Since dabigatran etexilate (Praxda) is a pro-drug controls cannot be made in the lab.

Dabigatran Plasma Calibrators enable the creation of a calibration curve for the measurement of Dabigatran in plasma, and are titrated and optimised for use with the HEMOCLOT Thrombin Inhibitors anti-IIa clotting assay. This assay is designed for the quantitative measurement of Hirudin, Argatroban, and other current and future direct thrombin inhibitors in plasma by their direct antithrombin activity. The calibrators and controls are currently being submitted to the FDA for approval using the HEMOCLOT Thrombin Inhibitor Kit.  If the dabigatran calibrators are used with other kits, results can vary according to the assay reactivity and its standardization.

For more information please contact Aniara Diagnostica LLC at info@aniara.com, visit our website at www.aniara.com or www.dabigatrantesting.com

Clinical coagulation laboratories have an opportunity to have lunch on Aniara Diagnostic LLC.  By entering a monthly lottery, you have a chance to win lunch for your lab. Winners are selected at random and if your location is selected, Aniara will contact you to make all of the necessary arrangements. Enter often to increase the odds of winning lunch for you and your colleagues. Set up a lunch and learn or just have a nice lunch with fellow co-workers.

For those clinical laboratories that may not accept lunch due to institutional policies, Aniara offers an alternative. If you enter and select the WIN & GIVE option, you’ll be entered for a chance to donate $300 to a chosen charity.

Entrants must represent a Clinical Corporation or Special Coagulation Laboratory to be eligible. To enter and for a list of terms and conditions and complete contest rules: Aniara | Lunch Lottery Terms & Conditions

Publications of NASCOLA Surveys, Proficiency Data, or “Test of the Month” articles:

1.      Hayward CM,  Moffat KA, Raby A, Israels S, Plumhoff E, Flynn G, Zehnder JL.  Development of North American Consensus for Medical Laboratories That Perform and Interpret Platelet Function Testing Using Light Transmission Aggregometry.  Am J Clin Pathol 2010; 134:955-963.    

2.      Khor B, Van Cott EM.  Laboratory tests for antithrombin deficiency. Am J Hematol 2010 (Dec); in press.

3.      Dembitzer FR, Ledford Kraemer MR, Meijer P, Peerschke EIB. Lupus anticoagulant testing: performance and practices by North American clinical laboratories.  Am J Clin Pathol 2010 (Nov); 134: 764-773.

4.      Otis SA, Zehnder JL.  Heparin-induced thrombocytopenia: Current status and diagnostic challenges.  Am J Hematol, 2010 (Sep); 85(9): 700-706. 

5.      Ledford-Kraemer MR.  Analysis of von Willebrand Factor (VWF) Structure by Multimer Analysis.  Am J Hematol, 2010 (May); 85(5): 510-514.  

6.      Smock KJ, Rodgers GM.  Laboratory evaluation of aspirin responsiveness.  Am J Hematol 2010; May;85(5):358-60. 

7.      Khor B, Van Cott EM.  Laboratory tests for protein C deficiency.  Am J Hematol 2010; Jun;85(6):440-2.

8.      Castellone D, Van Cott EM. Laboratory monitoring of new anticoagulants. Am J Hematol 2010 Mar;85(3):185-187.

9.      Van Cott EM. All that glitters is gold?  Am J Hematol. 2010 Apr;85(4):223-224.

10.  Smock KJ, Rodgers GM.  Laboratory identification of lupus anticoagulants.  Am J Hematol 2009 Jul;84(7):440-442.

11.  Nichols WL, Rick ME, Ortel TL, Montgomery RR, Sadler JE, Yawn BP, James AH, Hultin MB, Manco-Johnson MJ, Weinstein M.  Clinical and laboratory diagnosis of von Willebrand disease: a synopsis of the 2008 NHLBI/NIH guidelines. Am J Hematol. 2009 Jun;84(6):366-370.

12.  Peerschke EI, Castellone DD, Ledford-Kraemer M, Van Cott EM, Meijer P. Laboratory assessment of factor VIII inhibitor titer: the North American Specialized Coagulation Laboratory Association experience.  Am J Clin Pathol. 2009 Apr;131(4):552-558. 

13.  Hayward CPM, Moffat KA, Spitzer E, Timleck M, Plumhoff E, Israels SJ, White J. Results of an external proficiency testing exercise on platelet dense granule deficiency testing by whole mount electron microscopy. Am J Clin Pathol. 2009 May;131(5):671-675.

14.  Moffat KA, Ledford-Kraemer MR, Plumhoff EA, McKay H, Nichols WL, Meijer P, Hayward CPM. Are laboratories following published recommendations for lupus anticoagulant testing? An international evaluation of practices. Thromb Haemost. 2009 Jan;101(1):178-184.

15.  Cattaneo M, Hayward CPM, Moffat KA, Pugliano MT, Liu Y, Michelson AD. Results of a worldwide survey on the assessment of platelet function by light transmission aggregometry: a report from the platelet physiology subcommittee of the SSC of the ISTH. J Thromb Haemost 2009;7:1029.

16.  Verhovsek M, Moffat KA, Hayward CP. Laboratory testing for fibrinogen abnormalities.  Am J Hematol. 2008 Dec;83(12):928-931.

17.  Abstracts: 2nd Mayo/NASCOLA Coagulation Testing Quality Conference. Am J Hematol 2008(Dec);83(12):941-948.

18.  Price EA, Hayward CP, Moffat KA, Moore JC, Warkentin TE, Zehnder JL. Laboratory testing for heparin-induced thrombocytopenia is inconsistent in North America: a survey of North American specialized coagulation laboratories. Thromb Haemost. 2007 Dec;98(6):1357-1361. 

19.  Olson JD, Preston FE, Nichols WL.  External Quality Assurance in Thrombosis and Hemostasis: An International Perspective. Semin Thromb Hemost 2007;33:220–225.

20.  Van Cott EM, Ledford-Kraemer M, Meijer P, Nichols WL, Johnson SM, Peerschke EIB.  Protein S: An Analysis of the North American Specialized Coagulation. Laboratory Association Proficiency Testing.  Am J Clin Pathol 2005; 123: 778-785.

21.  Moffat KA, Ledford-Kraemer MR, Nichols WL, Hayward CP.  Variability in clinical laboratory practice in testing for disorders of platelet function: results of two surveys of the North American Specialized Coagulation Laboratory Association. Thromb Haemost. 2005 Mar;93(3):549-553.

Aniara recently announced the recipient of the 2009 Coagulation/Hemostasis Technologist Award for Excellence.  Marilyn Johnston, from NASCOLA member laboratory,  Hemostasis Reference Laboratory in Hamilton, Ontario, Canada, is the winner of this generous award.  She was nominated in 3 separate letters from peers and was ultimately chosen by the CHTAE selection committee. 

In addition to being recognized nationally and internationally for her contributions to the field of hemostasis, the committee was most impressed with her work in mentoring others.  Quotes from the nomination letters include:

“Marilyn has acted as mentor for a number of technologists and research fellows and continues to share her knowledge and expertise in the area of hemostasis and thrombosis. “

 “Marilyn encouraged her team to take the extra time and use the technology needed to dissect complex cases. She would bring in new technology when needed, adapt old technology if applicable and make up new technology if none existed. Many of the technologists working for Marilyn were inspired to achieve advanced certification by her mentorship.”

“Marilyn exemplified true entrepreneurial leadership in the creation and development of a unique hemostasis specialty testing laboratory for the purpose of aiding young medical researchers and laboratorians in the development of their career interest especially in the area of anticoagulation testing which continues to enhance the knowledge and understanding of hemostasis. Her contributions to the education of technologists, medical students and residents in the area of hemostasis are significant as exemplified by the numerous journal publications, scientific reviews, book chapters and speaking engagements.”

Our congratulations to Marilyn for a much-deserved award and recognition.  Thank you to Aniara (an Associate NASCOLA Member) for initiating and continuing to support this wonderful award. 

NASCOLA members, Kristi Smock and George Rodgers, have published a “Test of the Month” feature in the American Journal of Hematology on lupus anticoagulant testing.  The abstract is below, along with a link to the full article for NASCOLA members who are subscribers to the Wiley InterScience publications site:

Laboratory identification of lupus anticoagulants.

Lupus anticoagulants (LA) are acquired autoantibodies that can cause antiphospholipid syndrome. LAs prolong phospholipid-dependent coagulation tests, acting as nonspecific inhibitors that are neutralized in the presence of excess phospholipid. However, there is no gold standard test and the testing is influenced by a number of variables. This article summarizes laboratory testing for LAs, with particular focus on technical issues and limitations of testing.

Am J Hematol. 2009 Jul;84(7):440-2.

NASCOLA members, Ellinor Peerschke, Donna Castellone, Marlies Ledford-Kraemer, and Elizabeth Van Cott, along with Piet Meijer from ECAT, have published an analysis of factor VIII inhibitors as assessed by NASCOLA proficiency testing.  The abstract is below, along with a link to the full article for NASCOLA members who are subscribers to Am J Clin Pathol:

Laboratory assessment of factor VIII inhibitor titer: the North American Specialized Coagulation Laboratory Association experience.

Quantification of inhibitory antibodies against infused factor VIII (FVIII) has an important role in the management of patients with hemophilia A. This article summarizes results from the largest North American FVIII inhibitor proficiency testing challenge conducted to date. Test samples, 4 negative and 4 positive (1-3 Bethesda units [BU]/mL), were distributed by the ECAT Foundation in conjunction with the North American Specialized Coagulation Laboratory Association and analyzed by 38 to 42 laboratories in 2006 and 2007. Whereas laboratories were able to distinguish between the absence and presence of low-titer FVIII inhibitors, the intralaboratory coefficient of variation was high (30%-42%) for inhibitor-positive samples, and the definition of lower detection limits of the assay was variable (0-1 BU/mL). Most laboratories performed the Bethesda assay with commercially supplied buffered normal pooled plasma in a 1:1 mix with patient plasma. These data provide information for the development of consensus guidelines to improve FVIII inhibitor quantification.

Am J Clin Pathol. 2009 Apr;131(4):552-8.

NASCOLA members, Madeleine Verhovsek, Karen A. Moffat, and Catherine P.M. Hayward contributed the the "Test of the Month" feature in the American Journal of Hematology.  Following is the abstract of the publication and a link to the full text for those NASCOLA members who are subscribers to the Wiley InterScience publications site.

Laboratory testing for fibrinogen abnormalities

Fibrinogen is essential for the formation of a fibrin clot. Acquired and congenital disorders of fibrinogenmay result in decreased concentration or altered function of fibrinogen, often leading to an increased risk of bleeding. Routine coagulation testing and specialized laboratory investigations can guide diagnosis in patients suspected of having a fibrinogen abnormality. This article summarizes the types of laboratory assays that are used to assess fibrinogen disorders, and key abnormalities found in different types of fibrinogen disorders. Am. J. Hematol. 83:928–931, 2008. VVC 2008 Wiley-Liss, Inc.

The link to the full text for subscribers: 

In accordance with the open access policies of the journal Thrombosis and Hemostasis, and with the permission of the publishers and authors, a PDF version of a publication can be posted to a website.  As such, we are pleased to offer the latest publication from NASCOLA members.  The original article, entitled, "Are laboratories following published recommendations for lupus anticoagulant testing? An international evaluation of practice" is published in: Thrombosis and Haemostasis 2009;101(1):178-184. The original article can be accessed on-line at: www.schattauer.de

Are laboratories following published recommendations for lupus anticoagulant testing? An international evaluation of practice

2007 Committee Members:

• Lesley Black
• Elaine Castelli
• Donna Castellone
• George Fritsma
• Susan Hoffman
• Ed Reyes

The 2007 Committe's Decision:

"It is with great pleasure that this committee announces the selection of Karen Moffat as the 2007 reciepent of Aniara’s Coagulation Hemostasis Technologist of the year. This year over 23 letters were reviewed representing outstanding coagulation technologists, however Ms. Moffat’s achievements were exceptional. Her dedication to continuing education and excellence were made evident by her many publications and teaching efforts. She truly represents excellence in the field. We congratulate Karen and are proud to be represented by her."

"All of the nominees deserve to be congratulated for their work and contributions in the field. The committee would especially like to recognize the diligent efforts of Ms. Kim Pleus from Methodist Hospital in Indianapolis for her amazing life saving efforts in detecting overdosing of heparin in babies. She is a true asset to the field."

Catherine P.M. Hayward, MD, PhD
President of NASCOLA, on behalf of the NASCOLA Executive Committee

James Zehnder, MD
Chair, NASCOLA Education Committee