Tools and resources
5 The technologies
ROTEM
www.rotem.de
The ROTEM system, manufactured by Tem International, is a point-of-care analyser used to assist with the detection, management and monitoring of haemostasis. The device uses thromboelastometry, a method for testing haemostasis. This includes measurements relating to the initiation of clotting, platelet and fibrinogen function and hyperfibrinolysis.
The ROTEM system uses 5 assays to examine the clotting characteristics of a whole blood sample. These are available as liquid reagents or single-use reagents. The following table details the information provided by each.
|
Reagent |
Information provided |
|
in-tem |
Assessment of clot formation, fibrin polymerisation and fibrinolysis via the intrinsic pathway |
|
ex-tem |
Assessment of clot formation, fibrin polymerisation and fibrinolysis via the extrinsic pathway |
|
hep-tem |
Analysis without heparin influence: specific detection of heparin (compared to in-tem), assessment of clot formation in heparinised patients |
|
fib-tem |
Analysis without platelets: qualitative assessment of fibrinogen status |
|
ap-tem |
In-vitro fibrinolysis inhibition: detection of lysis when compared to ex-tem |
The ROTEM analysis is generally performed with citrated whole blood, at point of care, during surgery or post-operatively. The system can run 4 tests concurrently and provides step-by-step instructions and automated pipetting of blood and reagents to simplify the test procedure.
The results of the test are calculated and presented on a touch-sensitive computer screen in the form of a graph of the coagulation process over time. The results of up to 4 tests can be viewed alongside each other and example curves can also be viewed to aid interpretation. The initial test result is available within 5 minutes, followed by full results within 20 minutes.
Results can also be incorporated into patient data management systems utilising hospital information system and laboratory information system connectivity.
An example of the ROTEM result can be seen on the manufacturer's website and educational resources are available at http://learning.rotem.de.
Cost and procurement
At the time of publication (August 2014), the current UK pricing and other procurement options available are as follows:
-
Capital purchase: £24,950 plus VAT. Cost of assays vary; please contact the company for more information.
-
Rental options: a rent-to-buy scheme agreed over 1–3 years with final payment securing ownership of the device. This price varies depending on duration of agreement but is generally between £450 and £900 per month.
-
Leasing agreement: no capital outlay. The costs of the device and servicing can be spread over the cost of the reagents and consumables. This varies in price depending on the agreed duration of contract and test volume.
-
Consignment agreement: the device is placed and remains the property of TEM. Agreement is made on test volume at the beginning of the contract, with a minimum of 800 tests required per year. Usage is audited every 6 months to ensure consistency. If the agreed volume is reached, the contract continues; if not, the device may be purchased, rented or removed. Consumable costs are slightly higher and depend on whether servicing is included as part of the agreement.
Consumables:
|
Description |
Cost |
Number of tests |
|
in-tem |
£116.30 |
10x10 |
|
t ap-tem |
£111.00 |
10x5 |
|
r ex-tem |
£125.00 |
10x10 |
|
fib-tem |
£116.00 |
10x5 |
|
hep-tem |
£174.30 |
10x7 |
|
star-tem |
£65.60 |
10x20 |
|
in-tem S |
£128.10 |
20 |
|
ex-tem S |
£128.10 |
20 |
|
ap-tem S |
£202.00 |
20 |
|
fib-tem S |
£202.00 |
20 |
|
hep-tem S |
£211.10 |
20 |
|
ROTROL N Level I |
£60.50 |
5x4 |
|
ROTROL P Level II |
£60.50 |
5x4 |
|
Cup & pin pro |
£645.80 |
200 |
|
Tip Tray eLine |
£46.10 |
10x96 |
For further details and up-to-date costs of equipment, reagents and consumables please contact the company.
Contact details
TEM UK Ltd, 2 Rivergreen Business Centre, Queen's Meadow, Hartlepool, TS25 2DL
National Sales Manager – UK & ROI, Jim Leith, jim.leith@tem-international.co.uk 07824 361091.
Area Sales Manager – UK Midlands, Jon Hollinshead, jon.hollinshead@tem-international.co.uk 07823 328545.
Area Sales Manager – UK South, Adam Knight, adam.knight@tem-international.co.uk 07824 361096.
Area Sales Manager – Ireland, Declan Brennan, Declan@dsbmedical.ie 00353 87 222 1770.
Office Manager – Hartlepool, Julie Bolton, julie.bolton@tem-uk.com 01429 871517, Fax 01429 871258.
ROTEM Hotline – Service & Support, 01429 528419.
TEG
http://www.haemonetics.com
The TEG 5000 Haemostasis Analyser system is a diagnostic device that provides whole blood haemostasis testing, can help assess bleeding and thrombotic risks, and monitor antithrombotic therapies.
TEG is based on the viscoelastometric method but the mechanical systems are slightly different to the ROTEM system. The TEG 5000 Haemostasis System utilises different assays to provide the following information via 2 independent channels.
|
Reagent |
Information provided |
|
Kaolin – activated test |
Assessment of clot formation, fibrin polymerisation and fibrinolysis |
|
Kaolin with heparinase |
Assessment of clot formation in heparinised patients |
|
Platelet mapping |
Assessment of platelet function and monitoring of antiplatelet therapy |
|
Rapid TEG |
A more rapid measurement of the clot strength than a standard kaolin assay with the addition of a correlated ACT value and is used mainly in emergency situations such as trauma |
|
Functional fibrinogen assay |
Assessment of the impact of fibrinogen on clot strength and stability (made possible by the suppression of the platelet contribution factor) |
The TEG system can use platelet mapping to produce a picture of a patient's potential response to antiplatelet therapy relative to their overall haemostasis.
Graphical and numerical results are relayed through a computer interface where real-time analysis is displayed. They can also be viewed remotely in real time, via an appropriate hospital network. Results include the time until initial fibrin formation, the kinetics of fibrin formation and clot development, the ultimate strength and stability of the fibrin clot and clot lysis. An example TEG result and educational resources are available from the manufacturer's website.
Cost and procurement
-
Capital purchase option: a 2-channel TEG analyser with PC, printer and installation costs £10,000. If 4 channels are needed, the cost is £20,000. This cost includes all software, including training and support. Maintenance is included for the 1-year full warranty period. Following this, the customer can then take out a maintenance contract. This costs up to £2500 per analyser but a discount may be given for sites with multiple devices.
-
Use plan: under this scheme, the customer buys the reagents and the manufacturer loans the TEG systems. Volume levels are agreed, as is the length of the agreement (usually 3 years). Maintenance is included within this plan as Haemonetics still have ownership of the devices.
Consumables:
|
Description |
Cost |
Number of tests |
|
Kaolin Activator Vials (for standard testing) |
£2.72 |
1 (for 2 channels) |
|
Functional Fibrinogen test |
£8.75 |
1 |
|
Platelet Mapping Complete Kit for Kaolin/ADP/AA/Activator and 4 cups and pins |
£25.00 |
4 |
|
Rapid TEG Activator Vial (Tissue factor/Kaolin combination) Fast test |
£10.50 |
1 |
|
Biological QC Level I |
£7.21 |
1 (for 2 channels) |
|
Biological QC Level II |
£7.21 |
1 (for 2 channels) |
|
Plain Cup & Pin |
£5.45 |
1 |
|
Heparinase Cup & Pin (cup surface lyophilised) |
£8.75 |
1 |
For further details and up-to-date costs of equipment, reagents and consumables please contact the company.
Contact details
United Kingdom Sales Office
Haemonetics Ltd., Business Innovation Centre, Harry Weston Road, Coventry CV3 2TX
Contact Customer Support: 0808 234 4817 / 0808 234 4845
Email: Info.uk@haemonetics.com
Haemonetics (UK) Ltd, 5 Ashley Drive, Bothwell, Glasgow G71 8BS
Sonoclot
As discussed, NICE only recommends the Sonoclot system for use in research. The following information is provided for organisations which may wish to purchase the Sonoclot system for this purpose.
Current web address for UK distributor, Linc Medical Systems: www.linc-medical.co.uk
Current web address for manufacturer, Sienco Inc: www.sienco.com/sonoclot-worldwide/
The Sonoclot Coagulation and Platelet Function Analyser is a viscoelastic monitor used for measuring coagulation and platelet function in whole blood or plasma. It provides information on the haemostasis process including coagulation, fibrin gel formation, clot retraction and fibrinolysis. The Sonoclot utilizes the following assays.
|
Reagent |
Information provided |
|
kACT |
Assessment of large-dose heparin management with or without aprotonin |
|
aiACT |
Assessment of large-dose heparin management with aprotonin |
|
gbACT+ |
Assessment of overall coagulation and assesses platelet function in non-heparinised patients |
|
H-gbACT+ |
Assessment of overall coagulation and assesses platelet function in heparinised patients |
|
gbACT |
Assessment of overall coagulation in non-heparinised patients (without platelet function) |
The Sonoclot Analyser generates both a qualitative graph, known as the Sonoclot signature, and quantitative results on the clot formation time and the rate of fibrin polymerization. This helps to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effects, hypercoagulable tendencies and hyperfibrinolysis.
The results are automatically calculated. They appear on the LED display and are printed on the hard copy graphic output.
An example Sonoclot result and educational resources can be seen on the manufacturer's website.
Cost and procurement
Capital costs are as follows:
-
Single-channel device, gives ACT and CR: £2500.
-
Single-channel device, gives ACT, CR, PF and signature: £3950.
-
Double channel, gives ACT, CR, PF and signature: £7950.
-
4 channel, gives ACT, CR, PF and signature: £14,950.
Consumables:
|
Description |
Cost |
Number of tests |
|
C1/gbACT |
£52.80 |
24 |
|
C1/gbACT |
£200.00 |
100 |
|
C3/kACT |
£52.80 |
24 |
|
C3/kACT |
£200.00 |
100 |
|
C4/non activatd test box |
£52.80 |
24 |
|
C4/non activatd test box |
£200.00 |
100 |
|
C5/aiACT |
£66.00 |
24 |
|
C5/aiACT |
£250.00 |
100 |
|
H1/gbACT |
£132.00 |
24 |
|
H1/gbACT |
£500.00 |
100 |
|
P1/H-gbACT |
£165.00 |
20 |
|
P1/H-gbACT |
£375.00 |
50 |
|
Oil QC (for daily use) |
£120.00 |
24 |
|
Plasma QC (for use with new reagent batches) |
£37.50 |
1 |
For further details and up-to-date costs of equipment, reagents and consumables please contact the company.
Contact details
LINC Medical Systems, The Green Lane Workshop, Green Lane, Countesthorpe, Leicestershire, LE8 5QQ
Email:
sales@linc-medical.co.uk – General enquiries
joebailey@linc-medical.co.uk – Product specialist for Sonoclot
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