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Volume 5 Issue 1 May 2015
2
INSIDE THIS ISSUE:
STAR Max® 2
Customer Corner 3
Paediatric and Microtainer racks 4
iHemOStasis and Haemoscore 5
2015 Stago Catalogue 6
STA ECA II 7
STA Apixaban Cals and QC 8
Stago Educational Websites 9
Dates to remember 9
STAR Max® Diagnostica Stago is pleased to announce the availability of the new STAR Max®.
This analyser is the most advanced fully automated coagulation specific instrument on the market today.
The STAR series instrument is the analyser of choice in Public Hospitals throughout Australia and New Zealand with approxi-mately 90% of the largest labs utilising Stago as the analyser of choice. The STAR series analysers are equally suited to the high throughput private labs and compati-ble with Total Lab Automation (TLA) solu-tions by all the major suppliers (over 150 STAR installations on TLAs world-wide).
The STAR Max® retains the best features of the STAR series to ensure reliability of the new platform. There are some unique hardware innovations including a drop down tray for easy front loading of the cleaner solution as well as a space saving slide-up side cover providing easy access for cuvette loading.
The new software is brilliant incorporating customisable Expert Rules. These Expert Rules allow reflex testing to any test, re-runs, the use of delta checks, auto-comments, and auto-validation of results.
With accreditation in mind, the STAR Max® features Method Validation soft-ware to assist in lot validation compari-sons, repeatability studies, reproducibility studies, carryover and Measurement of Uncertainty calculations. Complete trace-ability for every patient result including reagent lot number, QC, and consuma-bles used in producing the result is avail-able at anytime.
The STAR Max® software also features easy to use workflow monitoring tools including Turn Around Time for any test customisable by date and time periods, location etc assessed against your labora-tory’s bench-mark.
You can even use the software to calcu-late your normal reference intervals in-cluding eg mean normal prothrombin time.
This high throughput, flexible, feature packed analyser is available now.
Please contact us to discuss the STAR Max® and your laboratory needs:
3
Stago Customers Corner Stago Customers Corner is
available via the
www.stago.com.au website.
You simply log-in (clicking
the log-in button top right)
and you will get access to
all your data and available
services.
The information available
includes: your laboratory
data eg your analysers,
orders and ID-card;
Material Safety Data Sheets,
Package Inserts, Barcode
Sheets, Instrument
Documents, and Standard
Operating Procedures
If you would like access to
Customer Corner please
contact us for your log-in
and password - it’s free !
4
STA Paediatric and Microtainer Racks
These Stago racks have been available
for a number of years enabling the easy
loading of paediatric and microcontain-
ers onto the STAR series analysers. The
use of these racks speeds up the loading
of these samples.
The GREEN Stago Paediatric Rack is de-signed to accommodate the 1.8ml Bec-ton Dickinson paediatric tubes present-ing them at the perfect height for sam-pling. The rack features a barcode label identifier which “tells” the STAR automat-ically that the rack contains paediatric
samples without the operator needing to specify this in the software.
From the Test panel screen, paediatric samples loaded on these racks are dis-played in green in the patient file list.
Dedicated BLUE racks for sample micro-volumes (microcontainers/aliquots) are used with the aluminum microtainer adaptors. There is no need to manually identify this sample type in the STAR software as this rack is barcoded and
“tells” the STAR that microvolume tubes are in the rack.
From the Test panel screen, microcon-tainers + adaptors loaded on these racks are displayed in blue in the patient file list.
The catalogue numbers for these Stago accessories are:
88349 Paediatric Rack
80203 Microtainer Rack
(2 racks per pack to suit all STAR se-ries analysers.)
5
Stago are pleased to announce the release
of our block buster applications iHemOSta-
sis and Haemoscore. These applications
are available free of charge from the Apple
App Store and Google play worldwide.
The iHemOStasis tablet application serves
as a haemostasis primer for anyone looking
to increase knowledge in the area. The
uncomplicated user interface offers four
areas of interest:
Coagulation Cascade: Major coagulation mechanisms are animated along with de-tailed explanations of each phase, including intracellular and extracellular components.
Quick Guide: Detailed descriptions of the most current assays used to examine he-mostasis in a global fashion along with vari-ous therapies, disease state classifications and decision trees.
Special Focus: Product literature supporting Stago’s anticoagulant, thrombin generation and flow cytometry products is housed, along with reference ranges for hemostasis tests in childhood and pregnancy.
Clinical Cases: Three case studies are pre-sented, along with quizzes to test the view-er’s knowledge.
The Haemoscore app is available for tablet and smartphone from the Apple Store and Google play.
Clinical scores and algorithms play a central role in modern patient care derived from evidence-based medicine.
Evidence based medicine provides guide-lines to physicians aimed at improving effi-cacy and safety of patient management.
An international expert panel has developed this application that compiles, in a clear and simples way, most recognised and useful clinical scores and diagnosis algorithms in the field of Thrombosis and Haemostasis.
Each algorithm includes the indication and a brief interpretation emphasising the most relevant aspects of each one followed by some representative references.
We hope his application may guide the clinician in the most appropriate diagnostic strategy, answering some of the questions that may arise when treating thrombotic and bleeding problems.
iHemOStasis and Haemoscore - Stago Apps for iPad and Android
6
The Stago 2015 Haemostasis Catalogue is available in softcopy or hardcopy.
Please drop us a line if you would like one and specify the desired format: [email protected]
7
STA® ECA II and Dabigatran Cal and QC
STA® - ECA II is intended for use with the
STA-R® analyzer for measuring the direct
anti-IIa activity of dabigatran in a competi-
tive assay using a synthetic chromogenic
substrate. The kit allows the quantitative
determination of dabigatran in the plasma
of patients taking the drug. The measure-
ment of dabigatran anti-IIa activity is con-
verted into dabigatran plasma concentra-
tion. This concentration is helpful for clini-
cians to assess the extent of anticoagula-
tion in situations requiring further charac-
terisation of the clinical picture.
Dabigatran has been cleared without any
laboratory monitoring based on its safe
PK/PD profile and short half life. However,
in certain circumstances such as emergen-
cy surgery or severe bleeding, measuring
the plasma concentration of dabigatran
may be useful for helping physicians in
medical decisions.
The STA® - ECA II assay is based on the
cleavage of prothrombin by ecarin, a snake
venom metalloprotease from Echis carina-
tus. The generated activation products
(mainly meizothrombin) enzymatically
cleave a chromogenic substrate resulting in
paranitroaniline release. This cleavage is
inhibited in a concentration-dependent
manner by direct thrombin inhibitors (DTI),
when present in the plasma sample.
The quantity of paranitroaniline released
measured at 405 nm is inversely propor-
tional to the amount of direct thrombin
inhibitors, such as dabigatran, present in
the plasma.
STA – ECA II contains 3 reagents
R1: Prothrombin – 3.5 mL
R2: Substrate – 2 mL
R3: Ecarin – 2 mL
STA – Dabigatran Calibrator has 5 levels of
calibrators :
0 - 50 - 100 - 175 - 250 ng/mL
STA – Dabigatran Control
2 levels of control :
60 - 200 ng/mL
The STA – ECA II reagents are stable on
board (Stago analyser) for 3 days but can
be stored in the refrigerator 2-8’C for 28
days.
The test turn around time is only 6
minutes.
The STA® ECA II working range is
15 to 460 ng/mL
The correlation of STA ECA II with HPLC/
MS measuring total dabigatran is excel-
lent.
The kit is available now for use on STAR
and STAR Max. An adaption for the STA
Compact Max is expected later this year
(2015). This Ecarin-based chromogenic
assay is a specific method for DTI meas-
urement providing accurate evaluation of
dabigatran levels in patients’ plasmas.
There is no interference from variations
of FII or fibrinogen levels, or from the
presence of heparin.
Look out for the poster at ISTH 2015,
Toronto by Dr Genevieve Freyburger.
00992 STA ECA II
00993 STA Dabigatran Calibrator
00994 STA Dabigatran Control
8
STA® Apixaban Cals and Controls are now CE marked
The STA® - Apixaban Calibrator kit is a set
of calibrator plasmas intended for use with
STA-R® and STA Compact® for calibration
of the measurement of apixaban anti-Xa
activity using the STA® - Liquid Anti-Xa
(REF 00311) kit. (Standard Operating Pro-
cedures are also available for non Stago
instrumentation.)
STA - Apixaban Calibrator & Controls al-
ready available as RUO (Research Use On-
ly) kits are now CE marked.
They retain the same catalogue numbers:
01075 STA - Apixaban Calibrator
01074 STA - Apixaban Control
STA - Apixaban Calibrator
•4 levels of calibrator : 0 - 100 - 250 - 500
ng/mL
•Stability: 4 hours on board
STA - Apixaban Control
•2 levels of control : 80 - 300 ng/mL
•Stability: 8 hours on board and 7 days at
2/8°C
Usually only one calibration is required per
lot number of STA Liquid Anti-Xa.
The Working range is 23 to 500 ng/mL
Test Turn around time: 6 minutes
The STA Liquid Anti-Xa method with STA
Apixaban Cal & Ctrl provides accuracy,
precision, and allows the measurement of
apixaban (Eliquis®) in any clinical situation
eg prior to urgent surgery, in case of
bleeding, to assess compliance, and in
case of suspected overdose.
The STA Liquid Anti-Xa method using the
dedicated STA Apixaban Calibrators shows
excellent correlation to LCMS (the “gold”
standard).
Look out for the poster at ISTH 2015.
The Stago 00311 STA Liquid Anti-Xa kit is
ideally suited to the urgent testing needs of
the busy laboratory. The liquid reagents
are barcoded and easy to use with long on-
board and refrigerated stabilities.
STA Liquid Anti-Xa is truly a universal anti-
Xa reagent with dedicated calibrators and
controls for heparin-like (UFH, LMWH and
Fondaparinux), Rivaroxaban, Apixaban and
Edoxaban (expected 2015). This chromo-
genic and specific anti-Xa method is not
affected by coagulation factors abnormali-
ties, levels of plasma proteins, or other
drugs (except anti-Xa drugs).
Diagnostica Stago is the partner of choice
for the measurement of anticoagulants
with the complete range of Anti-Xa and
DTI test kits, calibrators and controls.
1800 4 STAGO (78246) AUS
0508 4 STAGO (78246) NZ
9
Dates to Remember
Diagnostica Stago Pty. Ltd.
651 Doncaster Road
Doncaster, VIC, 3108
Australia
Phone (AUS): 1800 4 STAGO
Phone (NZ): 0508 4 STAGO
Fax: +61 3 9855 8999
www.stago.com.au
AUSTRALIA - NEW ZEALAND
At 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 pa-tients we serve.
Diagnostica Stago, has long been
committed to providing educational
support to haemostasis testing labor-
atories. 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 re-
source.
Australian and New Zealand partici-
pants can achieve APACE and CPD
continuing education credits and
certificates by registering and com-
pleting the activities on this site.
Please visit:
http://www.stago-edvantage.com
We are pleased to advertise the avail-
ability of educational resources at not
one but two Stago websites.
On a regular basis, keynote speakers
present interesting and topical
presentations on a variety of topics.
The webinar is available to view live
at a scheduled time and is available
on the website to view on-demand a
short time later. The live event allows
interaction with the presenter in real
time.
To participate all you need to do is
register at the website to gain access
and reminders of upcoming events.
Webinars on-demand currently avail-
able include: DDimers; HIT; NOACs;
LA; and the latest by Steve Kitchen
(UK) on QC in the Haemostasis La-
boratory.
Please visit:
http://www.stagowebinars.com
Stago
Webinars Live webinars
And available
on-demand
Congratulations to Kylie Twigg winner of the Stago
Prize awarded to the best Bachelor of Biomedical Science (Laboratory Medicine) student in their final year of study in 2014
RMIT University
Educational
Website 24 hours per day
7 days per week
Stago-EdVantage.com