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Posted: Monday, December 30, 2013

Stago Launches Products for Measurement of Apixaban

 

The STA® – Apixaban Calibrator and Controls are highly specific, automation-ready products for determining the apixaban concentration in plasma when used in conjunction with the STA® - Liquid Anti-Xa assay (catalog #s 00311US and 00322US).  This method has been shown to have excellent performance with respect to sensitivity, dynamic range of the assay, inter-subject variability and coefficient of variation (CV).1,2,3 

 

Apixaban (Eliquis®), a synthetically derived drug from Janssen Pharmaceuticals and Bayer Healthcare, inhibits the blood coagulation cascade by its inhibitory action on coagulation factor Xa, resulting in inhibition of fibrin clot formation.2

 

The STA® – Apixaban Calibrator (catalog # 01112) contains 4 calibrator points, establishing a linearity range of 20 to 500 ng/mL.  In addition, the STA® – Apixaban Control (catalog # 01111) product contains two levels of control at the low and high end of the calibrator range.  The calibrator is stable for 4 hours and the control for 8 hours on board the STA line of automated coagulation analyzers.  In addition, the reconstituted control is stable at 2-8° C for 7 days.

 

Utilization of STA® – Apixaban Calibrator and Controls ensures high specificity and precision for apixaban determination.  In addition, barcoding of critical information on the reagent vials prevents transcription errors.

 

The apixaban controls and calibrators are labeled for research use only, and are not for use in diagnostic procedures in the United States and Canada.

 

  1. Becker RC et al., Chromogenic laboratory assays to measure the factor-Xa inhibiting properties of apixaban - an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011; 32:  183-187
  2. Barret YC et al., Clinical laboratory measurement of direct factor Xa inhibitors: Anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010; 104:  1263-1271
  3. Barret YC et al., A randomized assessment of the pharmacokinetic, pharmacodynamic, and safety intereaction between apixaband and enoxaparin in healthy subjects. Thromb Haemost 2012; 107:  916=924

About Diagnostica Stago, Inc.

Diagnostica Stago, Inc. is the exclusive provider of the Diagnostica Stago Hemostasis product lines in the United States and offers a complete system of coagulation instruments and optimized reagent kits for research as well as for routine analysis. Diagnostica Stago, Inc. is the U.S. subsidiary of Diagnostica Stago, S.A.S. France, a leader in the development and manufacture of Hemostasis products. For more information about any Stago product or service, please call 800-222-COAG or visit our website at www.stago-us.com.

 

ELIQUIS is a registered trademark of Bristol-Myers Squibb Company.

 

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Contacts:

 

Hamid Erfanian, Director of Marketing

Diagnostica Stago, Inc.

(973) 867-2042

Hamid.Erfanian@us.stago.com

 

Posted: Monday, December 30, 2013

Stago Launches New Research Product for Antiplatelet Drug Testing

 

Diagnostica Stago Inc. has introduced a new enzyme-linked immunosorbent assay (ELISA) kit, Cy-Quant VASP/P2Y12 (cat # 01076) which is used to examine platelet responsiveness to specific platelet ADP receptor (P2Y12) antagonists and their in vitro effects.  In this way, this research assay can be used to determine the effectiveness of these anti-P2Y12 drugs such as clopidogrel (Plavix®), prasugrel (Effient®), and ticagrelor (Brilinta®).  The assay is P2Y12-specific and independent of other platelet receptors.  Aspirin and abciximab (ReoPro®) do not interfere.  In addition, platelet count and vWF level do not affect the assay.

 

This research-use-only (RUO) assay protocol is simple.  Small-volume citrated whole blood samples are used to measure intracellular platelet vasodilator-stimulated phosphoprotein (VASP) after exposure to different platelet agonists. 

 

Able to run on any plate reader reporting 450 nm wavelengths, this assay provides the VASP phosphorylation status, which after determination of platelet reactivity index (PRI), is then utilized as a surrogate biomarker for inhibited, activated or resting platelets.  The assay’s superior stability means that samples may be analyzed up to 48 hours after collection, allowing for analysis away from the original site of blood collection.  Individual, breakable wells allow for users to use only those reagents and disposables needed to run the assay, resulting with little or no waste.

 

Stago’s VASP assay is an alternative to traditional functional assays such as platelet aggregometry.  Additionally, this method offers inter-laboratory and day-to-day reproducibility as well as positive and negative threshold determinations.  The Cy-Quant VASP/P2Y12 kit is for research use only in the U.S. and Canada (not for use in diagnostic procedures).

 

About Diagnostica Stago, Inc.

Diagnostica Stago, Inc. is the exclusive provider of the Diagnostica Stago Hemostasis product lines in the United States and offers a complete system of coagulation instruments and optimized reagent kits for research as well as for routine analysis.  Diagnostica Stago, Inc.  is the U.S. subsidiary of Diagnostica Stago, S.A.S. France, a leader in the development and manufacture of Hemostasis products.  For more information about any Stago product or service, please call 800-222-COAG or visit our website at www.stago-us.com.

 

PLAVIX is a registered trademark of Bristol-Meyers Squibb/Sanofi Pharmaceuticals Partnership.  EFFIENT is a registered trademark of Eli Lilly and Company.  BRILINTA is a registered trademark of the AstraZeneca group of companies.  ReoPro is a registered trademark of Eli Lilly and Company. 

 

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Contacts:

 

Hamid Erfanian, Director of Marketing

Diagnostica Stago, Inc.

(973) 867-2042

Hamid.Erfanian@us.stago.com

 

Posted: Thursday, September 12, 2013

Stago Launches Products for Measurement of Rivaroxaban

 

We would like to announce that Diagnostica Stago, Inc. offers the STA® – Rivaroxaban Calibrator and Controls, which are highly specific, automation-ready products for determining the rivaroxaban concentration in plasma when used in conjunction with the STA® - Liquid Anti-Xa assay.  This method was shown to have favorable performance with respect to its linearity and coefficient of variation (CV) in a recent publication.1 

 

Rivaroxaban (Xarelto®), a synthetically derived drug from Janssen Pharmaceuticals and Bayer Healthcare, inhibits the blood coagulation cascade by its inhibitory action on coagulation factor Xa, resulting in inhibition of fibrin clot formation.2

 

The STA® – Rivaroxaban Calibrator (catalog # 00704US) and Control (catalog # 00706US) products contain two levels of control at the low and high end of the calibrator range.  Utilization of STA® – Rivaroxaban Calibrator and Controls ensures high specificity and precision for rivaroxaban determination. 

 

The rivaroxaban controls and calibrators are labeled for research use only, and are not for use in diagnostic procedures in the United States and Canada.

  1. Harenberg et al. Semin Thromb Hemost 2012; 38:  178-184
  2. Samama, Thromb Res 2011; 127:  497-504

 

XARELTO is a registered trademark of Janssen Pharmaceuticals, Inc.

 

Posted: Thursday, September 12, 2013

Stago’s Ecarin Chromogenic Assay Provides Precise Research-Use DTI Results

 

We would like to announce that the ecarin chromogenic assay (ECA) from Diagnostica Stago, Inc. is a highly-specific tool for determining the exact direct thrombin inhibitor (DTI) concentration in plasma without any sample interferences.

 

Unlike the activated partial thromboplastin time (aPTT), Stago’s ECA results are independent of coagulation factors and plasmatic inhibitors within the sample; and as it is not influenced by lupus anticoagulants, the assay allows for specific determination of the drug levels. ECA is insensitive to heparin, LMWH, fondaparinux and direct factor Xa antagonists. Additionally, the ECA dose response results are linear and do not plateau at elevated concentrations.

 

The ECA kit may be adapted to Stago’s automated instruments, and the wide measuring range includes two reagent formats dedicated to each DTI type (ECA-H for recombinant hirudins, ECA-T for synthetic DTIs). Recombinant hirudins include desirudin (REVASC®, Iprivask®). Synthetic DTIs include argatroban (Argatroban), bivalirudin (Angiomax®), and dabigatran etexilate (Pradaxa®). Specific standards and controls are also available. The ECA kit is for research use only in the United States and Canada, and is not for use in diagnostic procedures.

 

REVASC is a registered trademark of Canyon Pharmaceuticals Group. Iprivask is a registered trademark of Novartis AG. Argatroban is manufactured, distributed and marketed by GlaxoSmithKline. Angiomax is a registered trademark of The Medicines Company. Pradaxa is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co.

Contacts:

 

Paul Riley, PhD

Manager, Research Use Products

Diagnostica Stago, Inc.

(973) 631-1200 x4238

paul.riley@stago-us.com

 

Posted: Thursday, February 17, 2011

Dabigatran controls and calibrators available from Aniara Diagnostica LLC

 

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

 

 

Posted: Wednesday, January 19, 2011

New Products from r2 Diagnostics

 

r2 Diagnostics has announced the introduction of new venom screen and confirm reagents for detection of lupus anticoagulants.

 

LupoTek DetecTin VL and CorrecTin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated plasma.  LupoTek DetecTin VL and LupoTek CorrecTin VL use Vipera lebetina venom (VLV) rather than Vipera russelli (Russell’s Viper) venom (RVV). Using VLV is more eco-friendly than using RVV, as the VL viper is less endangered than the VR viper.

 

Vipera lebetina venom (VLV), like Russell's viper venom (RVV), will directly activate Factor X without requiring Factor VII. The activated Factor X in conjunction with Factors V, II, calcium ions and phospholipid will generate thrombin which converts fibrinogen to fibrin, producing a clot in the test system.

 

LupoTek DetecTin VL, the low phospholipid reagent, is designed as the screening reagent to detect a prolongation of the clotting time. LupoTek CorrecTin VL is the high phospholipid reagent that neutralizes the LA and corrects the clotting time to normal, confirming the presence of a Lupus Anticoagulant.

 

LupoTek DetecTin VL and CorrecTin VL demonstrated sensitivity of 100% and specificity of 100% with a normalized ratio of 1.30 in a 122 patient cutoff study.

 This reagent combination also demonstrated 98% positive agreement, 96% negative agreement, and 97% overall agreement with dRVV reagents in a 155 patient, multisite study.

 

 

LupoTek KCT - Kaolin Clotting Time - is also intended to assist in the detection of lupus anticoagulants in citrated plasma, and recently gained FDA 510(K) clearance. The LupoTek KCT is a modified activated partial thromboplastin time (APTT) reagent without any added phospholipids.  The KCT is exquisitely sensitive to LA, and has been reported as the most sensitive test for LA. (Lesperance B, David M, Rauch J, Infante-Rivard C, Rivard GE: Relative sensitivity of different tests in the detection of low titer lupus anticoagulants. Thromb Haemost 1988 Oct 31;60(2):217-219)

 

In a study of 180 patients, the KCT demonstrated 100% agreement in previously diagnosed LA patients and  59% agreement in those patients who were determined to have no evidence of  LA as compared to an APTT using a LA-sensitive reagent,  which demonstrated  87% agreement in the LA- positive group and 15% agreement in the LA-negative group.

 

The LupoTek KCT is suitable for use on most semiautomated and automated coagulation analyzers.

 

Posted: Friday, November 20, 2009

NASCOLA members contribute to “Test of the Month” feature in the American Journal of Hematology

 

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.


The link to the full text for subscribers
 

Posted: Friday, November 20, 2009

NASCOLA members publish in American Journal of Clinical Pathology: Laboratory assessment of factor VIII inhibitor titer: the North American Specialized Coagulation Laboratory Association experience.

 

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.


The link to the full text for subscribers
 

Posted: Thursday, June 11, 2009

NASCOLA Member Publication III

 

 

NASCOLA member, William L. Nichols contributed to 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.

Clinical and laboratory diagnosis of von Willebrand disease: A synopsis of the 2008 NHLBI/NIH guidelines


Von Willebrand factor (VWF) mediates blood platelet adhesion and accumulation at sites of blood vessel injury, and also carries coagulation factor VIII (FVIII) that is important for generating procoagulant activity. Von Willebrand disease (VWD), the most common inherited bleeding disorder, affects males and females, and reflects deficiency or defects of VWF that may also cause decreased FVIII. It may also occur less commonly as an acquired disorder (acquired von Willebrand syndrome). This article briefly summarizes selected features of the March 2008 evidence-based clinical and laboratory diagnostic recommendations from the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel for assessment for VWD or other bleeding disorders or risks. Management of VWD is also addressed in the NHLBI guidelines, but is not summarized here. The VWD guidelines are available at the NHLBI Web site http://www.nhlbi.nih.gov/guidelines/vwd). Am. J. Hematol. 84:366–370, 2009.



The link to the full text for subscribers: 

 

Updated: Tuesday, June 02, 2009

Posted: Tuesday, February 03, 2009

NASCOLA Recognition Award 2009

 

NASCOLA is pleased to announce that Dr. James White was awarded the first NASCOLA Recognition Award Program at the 2009 NASCOLA/Mayo Clinic Meeting.  Dr. White received this recognition for his life long contributions to laboratory assessment of platelet ultrastructure, including his pioneering work on using electron microscopy in the diagnosis of platelet disorders. He is widely recognized as a world leader in our field. He has made sentinel discoveries on the structural defects in platelets from individuals with platelet disorders.

The NASCOLA recognition award is a nonmonetary prize, awarded every two years, to recognize outstanding achievements and contributions of members. We encourage you to begin thinking about nominations for 2011. There are two award categories: one at the technologist level, and the other at the physician/scientist level.
 Nominations should include a letter or letters of recommendation, that outline why you feel an individual should be nominated for a recognition award.  Multiple letters for nominees are welcome – at least one must be from a NASCOLA member.  Please note, to be eligible for a recognition award, the nominees must be affiliated with an active NASCOLA institutional membership. In early 2011, we be welcoming your nominations again.

We congratulate Dr. White on his achievements!

 

Posted: Friday, January 16, 2009

NASCOLA Member Publications II

 

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: 

 

Posted: Thursday, January 15, 2009

NASCOLA Member Publications

 
 

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

 

Posted: Thursday, November 20, 2008

2008 Coagulation/Hemostasis Technologist Award for Excellence

 
Every year, the ANIARA Coagulation / Hemostasis Technologist Award for Excellence (CHTAE) Committee recognizes a Special Coagulation Technologist in the North American continent by awarding one technologist the "The 2007 Coagulation/Hemostasis Technologist Award for Excellence" award and a check in the amount of $1,000, at the annual ASH meeting. The committe chooses the recipient from a large pool of nominations that are received every year. ANIARA Corporation does not participate in the selection process. The selection is made a by a committee of volunteer peers. The committee reviews the applications and votes to determine the recipient of the award.

2007 Committee Members:

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

The 2007 Committe's Decision:

Karen Moffat

"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."

 

Posted: Monday, April 28, 2008

Opportunity for Member Trainees

 
NASCOLA thanks its member laboratories for their enthusiastic participation in the ISTH initiative on standardizing platelet aggregation studies. This initiative, led by the Platelet Physiology Scientific Subcommittee of the International Society on Thrombosis and Haemostasis (SSC/ISTH), was an important step forward in gathering information on how aggregation testing is done worldwide. The ultimate goal is to develop a consensus on standardizing the many pre-analytical and analytical variables that affect the results of platelet aggregation studies. A preliminary report on the findings was presented at the ISTH meeting in Geneva by Dr. Marco Cattaneo, Chair of the “Working Party on Platelet Aggregation” and the group will be analyzing further the collected information on practices. Thank you once again for your important involvement in this initiative.

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

James Zehnder, MD
Chair, NASCOLA Education Committee