Embed Size (px)
Citation preview
1
Volume 3, Issue 2Volume 3, Issue 2Volume 3, Issue 2Volume 3, Issue 2 October 2012October 2012October 2012October 2012
Stago Newsletter
2
INSIDE THIS ISSUE:INSIDE THIS ISSUE:INSIDE THIS ISSUE: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
The Spring Edition 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 28-31.
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: [email protected]
and visit our website: www.stago.com.au
3
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 ses-
sion with an update on the
Tcoag line of reagents and in-
struments 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
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 feed-
back and let us know about
your issues so we can
endeavour to do our best to
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
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:
4
Rivaroxaban QC and Calibrators now available
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 inhibi-
tors. 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.
00704 STA® Rivaroxaban Calibrator
(3 vials x 4 levels x 1ml)
00706 STA® Rivaroxaban Control
(3 vials x 2 levels x 1ml)
Email [email protected]
fax +61 3 9855 8999 or
phone 1800 4 78246 Australia
0508 4 78246 New Zealand
5
New Routine Quality ControlNew Routine Quality ControlNew Routine Quality ControlNew Routine Quality Control
Diagnostica Stago Diagnostica Stago Diagnostica Stago Diagnostica Stago is pleased to announce the availability of new
quality control material for routine
coagulation testing.
00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml normal
and abnormal control plasmas for PT,
INRINRINRINR, APTT, fibrinogen, thrombin time
(normal) and AT.
00714 STA®00714 STA®00714 STA®00714 STA®----Routine QC P PLUS Routine QC P PLUS Routine QC P PLUS Routine QC P PLUS is
our new abnormal plus control level for
PT (Sec), APTT, Fib, TT, AT.
These new QC’s have excellent onononon----
board stability of 24 hours board stability of 24 hours board stability of 24 hours board stability of 24 hours (STA-
Compact® and STA-R® analysers) and
a 2ml vial size2ml vial size2ml vial size2ml 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 25-45 seconds (abnormal ++)
APTT >85 secs (abnormal +++)
Fibrinogen 1-2 g/L (abnormal ++)
Thrombin Time 35-50 secs (abnormal)
Antithrombin 40-60% (abnormal ++)
The new 00714 STA®00714 STA®00714 STA®00714 STA®----Routine QC P Routine QC P Routine QC P Routine QC P
PLUS PLUS PLUS PLUS complements our existing range
of assayed quality control material
00679 STA® Coag Control N+P,
00678 STA® System Control N+P and
00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml and
provides values covering the analytical
range encountered in the laboratory.
00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml 00554 STA® Routine QC 2ml
00714 STA® 00714 STA® 00714 STA® 00714 STA® ---- Routine QC P PlusRoutine QC P PlusRoutine QC P PlusRoutine QC P Plus
EmailEmailEmailEmail [email protected]
faxfaxfaxfax +61 3 9855 8999 or
phonephonephonephone 1800 4 78246 Australia
0508 4 78246 New Zealand
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. NowNowNowNow 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 low low low
molecular weight heparin molecular weight heparin molecular weight heparin molecular weight heparin and
unfractionated heparinunfractionated heparinunfractionated heparinunfractionated heparin using the 00348
STA® Multi Hep Calibrator. This is a set
of 5 calibrators covering the
measurement range 0-2.0 IU/ml.
Alternatively, separate curves can be
established using these calibrators for
LMWH and UFH anti-Xa measurement.
Specific matched QC is available too:
00381 STA® Quality UFH and
00686 STA® Quality LMWH.
ml and the 00706 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 [email protected] for
more information and pricing.
Make the switch now !Make the switch now !Make the switch now !Make the switch now !
Diagnostica Stago can also provide you
with calibrators and controls for
monitoring Fondaparinux Fondaparinux Fondaparinux Fondaparinux (Arixtra®) and
RivaroxabanRivaroxabanRivaroxabanRivaroxaban (Xarelto®) using the STA®
Liquid Anti-Xa kit.
00354 STA® Fondaparinux Calibrator
provides a working range of 0.1-2.0 ug/
ml with matching controls 00355 STA®
Fondaparinux Control (6 x 2 levels x
1ml) having target values of 0.5 and 1.4
ug/ml.
The 00704 STA® Rivaroxaban Calibrator
set provides a working range 0-500 ng/
STA® Liquid An�-Xa to replace
STA® Rotachrom Heparin
6
A new test for HITTS
HHHHeparin IIIInduced TTTThrombocytopenia (HITHITHITHIT)
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 ExpertExclusion step: STic ExpertExclusion step: STic ExpertExclusion step: STic Expert® ® ® ® HITHITHITHIT
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® Confirmation step: Asserachrom® Confirmation step: Asserachrom® Confirmation step: Asserachrom®
HPIAHPIAHPIAHPIA----IgGIgGIgGIgG
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 RememberDates to RememberDates to RememberDates to Remember
August 27August 27August 27August 27----31, 201231, 201231, 201231, 2012
NZIMLS NZIMLS NZIMLS NZIMLS Annual Scientific Meeting 2012Annual Scientific Meeting 2012Annual Scientific Meeting 2012Annual Scientific Meeting 2012
Wellington Convention Centre, Wellington, New Zealand http://www.eenz.com/nzimls12/
____________________________________________________________
September 24September 24September 24September 24----27, 201227, 201227, 201227, 2012
AIMS National Scientific Meeting 2012AIMS National Scientific Meeting 2012AIMS National Scientific Meeting 2012AIMS National Scientific Meeting 2012
Darwin Convention Centre Darwin, Australia http://www.aims.org.au ____________________________________________________________
October 28October 28October 28October 28————31, 201231, 201231, 201231, 2012
APSTH and HAA 2012APSTH and HAA 2012APSTH and HAA 2012APSTH and HAA 2012 (ASTH Workshop October 27, 2012(ASTH Workshop October 27, 2012(ASTH Workshop October 27, 2012(ASTH Workshop October 27, 2012————Melbourne Convention and Exhibition Centre Melbourne Convention and Exhibition Centre Melbourne Convention and Exhibition Centre Melbourne Convention and Exhibition Centre Room 212)Room 212)Room 212)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 http://www.fcconventions.com.au/HAA2012
____________________________________________________________
29 June 29 June 29 June 29 June –––– 4 July 20134 July 20134 July 20134 July 2013
XXIV ISTH Congress with 59th Annual SSC Meeting 2013XXIV ISTH Congress with 59th Annual SSC Meeting 2013XXIV ISTH Congress with 59th Annual SSC Meeting 2013XXIV ISTH Congress with 59th Annual SSC Meeting 2013
Frits R. Rosendaal, President Amsterdam, The Netherlands http://www.isth2013.org
Diagnostica Stago Pty. Ltd.Diagnostica Stago Pty. Ltd.Diagnostica Stago Pty. Ltd.Diagnostica Stago Pty. Ltd.
651 Doncaster Road651 Doncaster Road651 Doncaster Road651 Doncaster Road
Doncaster, VIC, 3108Doncaster, VIC, 3108Doncaster, VIC, 3108Doncaster, VIC, 3108
AustraliaAustraliaAustraliaAustralia
Phone (AUS): 1800 4 STAGOPhone (AUS): 1800 4 STAGOPhone (AUS): 1800 4 STAGOPhone (AUS): 1800 4 STAGO
Phone (NZ): 0508 4 STAGOPhone (NZ): 0508 4 STAGOPhone (NZ): 0508 4 STAGOPhone (NZ): 0508 4 STAGO
Fax: +61 3 9855 8999Fax: +61 3 9855 8999Fax: +61 3 9855 8999Fax: +61 3 9855 8999
[email protected]@[email protected]@stago.com
www.stago.com.auwww.stago.com.auwww.stago.com.auwww.stago.com.au
AUSTRALIAAUSTRALIAAUSTRALIAAUSTRALIA————NEW ZEALANDNEW ZEALANDNEW ZEALANDNEW ZEALAND
At the Heart of HaemostasisAt the Heart of HaemostasisAt the Heart of HaemostasisAt the Heart of Haemostasis
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:
http://www.stago-edvantage.com/
Educational Website Educational Website Educational Website Educational Website
24 hours per day 7 days per week24 hours per day 7 days per week24 hours per day 7 days per week24 hours per day 7 days per week
Welcome to StagoWelcome to StagoWelcome to StagoWelcome to Stago----EdVantage.comEdVantage.comEdVantage.comEdVantage.com
