Stago Newsletter. Volume 3, Issue 2 October 2012

Transcription

1 1 Stago Newsletter Volume 3, Issue 2 October 2012

2 2 The Spring Edition INSIDE THIS ISSUE: The Spring Edition 2 Stago Symposium HAA/ASPTH 2 Stago User Group Meeting 3 Rivaroxaban Cals and QC 4 STA Liquid Anti-Xa 5 STA Routine QC 2ml 5 Stago STic Expert HIT 6 Dates to remember 7 A busy period is upon us with the NZIMLS Annual Scientific Meeting held in Wellington, August 27-31; AIMS National Scientific Meeting in Darwin, September 24-27; ASTH Workshop Melbourne, October 27; and HAA/ASPTH Conference in Melbourne October Diagnostica Stago is a major sponsor for the HAA/APSTH. We are holding a Stago Symposium on Monday October 29 at 5pm. Please see the invitation below and everyone is welcome. In September, Diagnostica Stago held a User Group Meeting in Melbourne. Please see inside for the full report. CDs of the presentations are now available. Stago staff will be delivering these over the next few months to attendees. If you would like a CD please let us know. Stago are pleased to announce the availability of Rivaroxaban calibrators and controls for use with the Anti-Xa method. See page 4 for details. Don t forget about our new STA Liquid Anti-Xa kit which is available now. The STA Rotachrom Heparin kit is being phased out over the next 6 months. Assayed Routine Quality Controls are now available in 2ml size with 24 hour stability. More information on page 5. In this edition you will also find some information about the new Stago STic Expert HIT screening test for suspected Heparin Induced Thrombocytopenia. This test allows the exclusion of HIT when combined with the pretest clinical score. The unitary test is IgG specific and includes an in-built control. It also has a long shelf-life. It is very easy to use and read, with results available in just 10 minutes. See page 6 for details. If you have any questions or feedback please contact us: info@stago.com and visit our website:

3 The Stago UGM The 2012 Stago ANZ User Group Meeting took place at the Skyline Conference Centre, Melbourne, Australia on September 4 and 5. The Skyline is on level 12 of the Victoria University building in the heart of Melbourne commanding outstanding views. Over 100 customers attended from all parts of Australia and New Zealand to hear about Diagnostica Stago reagents and instrumentation. David Courtois (Stago France) presented on the new Stago STic Expert HIT screening test for Heparin Induced Thrombocytopenia. Some local data was also presented in support of the STic Expert HIT kit, together with discussion of Stago Rivaroxaban Calibrators and Controls, and the new STA Liquid Fib (liquid stable fibrinogen), which will be available soon. Kevin Paull (General Manager Stago ANZ) presented an update of our company performance since the last UGM in 2010 derived from customer feedback. Customers were able to identify the positive aspects of working together to achieve excellent performances in service and applications support areas. We see the service provided as being just as important as the products we provide. These surveys monitor how we are going in this regard. We encourage you to continue providing feedback and let us know about your issues so we can endeavour to do our best to achieve a great outcome for you. Kevin also discussed the Key Performance Indicator reports that we can supply to you on a regular basis to give a comprehensive review of ordering patterns, hotline calls, phone fix rates, engineer on-site response times, and instrument service history. The KPI's we provide are highly regarded. Kevin ended the meeting session with an update on the Tcoag line of reagents and instruments and what customers can expect as Diagnostica Stago takes over distribution of Tcoag in October this year. Vicki Guppy (Technical Support Manager Stago ANZ) provided a review of the Quality Assurance in the Stago Manufacturing Process to assure customers of the comprehensive quality management that is integral to the manufacture of all Stago products. Vicki also presented the new STA Liatest DDimer Plus and Fibrinolysis range and the changeover from the congenital deficient Factor XII (STA Factor Def XII) to the new Stago Immunodepleted Factor XII. The UGM was also the opportunity to provide our customers with a presentation and sneak peek at the new STA Compact Max by Dave Harrison (Sales and Marketing Manager Stago ANZ). Feedback shows the new STA Compact Max will hit the mark for meeting customer expectations and instrument requirements. It will be on show at HAA in October. We were privileged to have Dr Kate Burbury (Clinical Haematologist at Peter MacCallum Cancer Centre) present on the clinical challenges faced by the medical team when wanting to perform surgery on warfarin anti-coagulated patients. Dr Burbury discussed the strategy for Warfarin Reversal using Vitamin K in these patients and the very successful outcomes obtained. Several customers shared their experiences on a number of topics including a Stago Factory visit by Sarah Just (Prince of Wales Hospital), Liverpool SSC 2012 meeting highlights by Geoff Kershaw (Royal Prince Alfred Hospital), an interesting case study by Margaret Collecutt (Alfred Hospital) of a patient undergoing heart bypass surgery requiring heparin 3 reversal but having protamine sulphate antibodies, Thrombin Generation experiences with the CAT by David Patterson (Canterbury Health Laboratory NZ), and a Local ISI calibration protocol by Kent Chapman (John Hunter Hospital). Jean Dufraisse (Business Development Manager Stago Australia and Japan) presented on Stago's Mission and Vision, Global expansion, as well as the humanitarian side of our organisation provided through corporate sponsorship. Finally, Leigh Robertson (Service Manager Stago ANZ) presented some topical "Tool Time" tips concerning the Liquid Level Detection system and troubleshooting, Cap Piercing and troubleshooting, New STA-R Evolution Expert PBR Cap Piercing System and Analyser data files used in troubleshooting. During the dinner on the first night, we were entertained by Simon Taylor (Comedian). Simon loves psychology. His enthusiasm for the human mind turned into a comedy show about morality, happiness, language and love. Simon had the audience transfixed and thoroughly entertained. The CD of presentations will be distributed to attendees. If you would like a copy please contact: info@stago.com

4 Rivaroxaban QC and Calibrators now available 4 Rivaroxaban is a new oral an coagulant, direct factor Xa Inhibitor, developed by Bayer HealthCare and sold under the trade name Xarelto. It is approved in three indica ons in Europe: preven on of stroke and systemic embolism in adult pa ents with non-valvular atrial fibrilla on (AF) with one or more risk factors treatment of deep vein thrombosis (DVT) and preven on of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults preven on of VTE in adult pa ents undergoing elec ve hip or knee replacement surgery. In the US, Xarelto is approved for stroke preven on in AF pa ents and preven on of VTE in hip or knee surgery. In April 2012, the TGA approved Xarelto for the preven on of stroke and systemic embolism in pa ents with non-valvular atrial fibrilla on (NVAF) and at least one addi onal risk factor for stroke, and treatment of deep vein thrombosis (DVT) and preven on of recurrent DVT and pulmonary embolism in Australia. In total, Rivaroxaban is approved in more than 110 countries worldwide. This makes Rivaroxaban a future major player in the world of an coagulants. Rivaroxaban is contraindicated in renal impairment (crea nine clearance <15mL/min), moderate and severe hepa c impairment with elevated INR, or with azole an fungals or HIV-protease inhibitors. These increase blood levels of Rivaroxaban and therefore bleeding risk. The Stago STA -Rivaroxaban Calibrator & Control, is a new solu on for the determina on of Rivaroxaban concentra on required to support the examina on of pa ents in different clinical situa ons. This solu on uses the an -Xa method (00311 STA -Liquid An -Xa), is insensi ve to analy cal and biological variables, and has a wide working range STA Rivaroxaban Calibrator (3 vials x 4 levels x 1ml) STA Rivaroxaban Control (3 vials x 2 levels x 1ml) info@stago.com fax or phone Australia New Zealand

5 STA Liquid An -Xa to replace STA Rotachrom Heparin 5 In early 2011 we announced the availability of the new STA Liquid Anti-Xa kit. By the middle of 2013 the STA Rotachrom Heparin kit will no longer be available. Now is the time for you to have a look at and changeover to the new kit. The STA Liquid Anti-Xa (Catalogue number 00311) has an on-board stability of 7 days, an open vial storage stability at 2-8 C of 3 months and a shelf life of ~24 months On a single curve, the laboratory can assess the anti-xa activity for low molecular weight heparin and unfractionated heparin using the STA Multi Hep Calibrator. This is a set of 5 calibrators covering the measurement range IU/ml. Alternatively, separate curves can be established using these calibrators for LMWH and UFH anti-xa measurement. Specific matched QC is available too: STA Quality UFH and STA Quality LMWH. Diagnostica Stago can also provide you with calibrators and controls for monitoring Fondaparinux (Arixtra ) and Rivaroxaban (Xarelto ) using the STA Liquid Anti-Xa kit STA Fondaparinux Calibrator provides a working range of ug/ ml with matching controls STA Fondaparinux Control (6 x 2 levels x 1ml) having target values of 0.5 and 1.4 ug/ml. The STA Rivaroxaban Calibrator set provides a working range ng/ New Routine Quality Control ml and the STA Rivaroxaban Control set has 2 levels of QC with target values of 80 ng/ml and 300 ng/ ml respectively. Please contact your Diagnostica Stago representative or info@stago.com for more information and pricing. Make the switch now! Diagnostica Stago is pleased to announce the availability of new quality control material for routine coagulation testing STA Routine QC 2ml normal and abnormal control plasmas for PT, INR, APTT, fibrinogen, thrombin time (normal) and AT STA -Routine QC P PLUS is our new abnormal plus control level for PT (Sec), APTT, Fib, TT, AT. These new QC s have excellent on- board stability of 24 hours (STA- Compact and STA-R analysers) and a 2ml vial size. The QC target and ranges are supplied on a barcode sheet for easy importing into Stago instruments. The expected values for the STA - Routine QC P Plus material using Stago reagents are: PT seconds (abnormal ++) APTT >85 secs (abnormal +++) Fibrinogen 1-2 g/l (abnormal ++) Thrombin Time secs (abnormal) Antithrombin 40-60% (abnormal ++) The new STA -Routine QC P PLUS complements our existing range of assayed quality control material STA Coag Control N+P, STA System Control N+P and STA Routine QC 2ml and provides values covering the analytical range encountered in the laboratory STA Routine QC 2ml STA - Routine QC P Plus info@stago.com fax or phone Australia New Zealand

6 6 A new test for HITTS Heparin Induced Thrombocytopenia (HIT HIT) is an immunologic adverse reaction of heparin therapy. Antibody-mediated platelet activation and consequent thrombin generation result in a fundamental paradox: venous and/or arterial thrombosis occurs despite the administration of an anticoagulant. Prompt diagnosis and shift to an alternative anticoagulant are key to avoid serious complications for the patient. Neverthless, diagnosis of HIT can be problematic. An efficient clinical assessment combined with HIT tests with high NPV and PPV allows one to: safely rule-out HIT and contribute to reduce the occurrence of overdiagnosis diagnose HIT with a high specificity Stago offers a range of products for HIT diagnosis that complies with ISTH recommendation and address customers needs. Exclusion step: STic Expert HIT It is a screening test for all HIT suspected cases. A unitary, rapid and easy to use test, it allows clinicians to make a decision based on clinical data and laboratory results regarding heparin management when a patient is suspected of HIT. With a high Negative Predictive Value, it allows exclusion of HIT when combined with a clinical score (~90% of HIT suspected patients). IgG specific, with a high specificity, it reduces over-diagnosis and overtreatment. Confirmation step: Asserachrom HPIA-IgG IgG IgG specific ELISA assay with unrivalled performance which allows confirmation or exclusion of HIT when used in combination with a functional test (SRA/ HIPA).

7 Dates to Remember 7 August 27-31, 2012 NZIMLS Annual Scientific Meeting 2012 Wellington Convention Centre, Wellington, New Zealand September 24-27, 27, 2012 AIMS National Scientific Meeting 2012 Darwin Convention Centre Darwin, Australia October 28 31, 2012 APSTH and HAA 2012 (ASTH Workshop October 27, 2012 Melbourne Convention and Exhibition Centre Room 212) Asian-Pacific Society on Thrombosis and Hemostasis and Annual Scientific Meeting of the HAA (HSANZ, ANZSBT and ASTH Annual Scientific Meeting, 2012) Melbourne Convention and Exhibition Centre Melbourne, Australia 29 June 4 July 2013 XXIV ISTH Congress with 59th Annual SSC Meeting 2013 Frits R. Rosendaal, President Amsterdam, The Netherlands Educational Website 24 hours per day 7 days per week Welcome to Stago-EdVantage.com New science and the transfer of knowledge leads to new standards of care, better patient outcomes and improved quality of life for the patients we serve. Diagnostica Stago, has long been committed to providing educational support to haemostasis testing laboratories. Our customers participate by providing feedback and program requests on specific topics that may aid them in the use of our products or provide knowledge to better serve as their institution s haemostasis resource. Australian and New Zealand participants can achieve APACE and CPD continuing education credits and certificates by registering and completing the activities on this site. Please visit: AUSTRALIA NEW ZEALAND At the Heart of Haemostasis Diagnostica Stago Pty. Ltd. 651 Doncaster Road Doncaster, VIC, 3108 Australia Phone (AUS): STAGO Phone (NZ): STAGO Fax: info@stago.com