CS-5100 SOP – Prothrombin Time / INR
Document ID: SUKBMS-13-384
Date: 12/10/2015
Version: 3.0
Contents
1.0 Purpose and Scope of SOP ...................................................................................... 2
2.0 Responsibility ............................................................................................................ 2
3.0 References ................................................................................................................. 3
4.0 Definitions .................................................................................................................. 3
5.0 Documentation .......................................................................................................... 4
6.0 Actions and Methods ................................................................................................ 5
6.1 Health and Safety ............................................................................................................. 5
6.2 Principle of Test................................................................................................................ 6
6.2.1 CS-5100 Analyser ........................................................................................................ 6
6.2.2 Prothrombin Time / INR................................................................................................ 7
6.3 Personnel Level of Training Required............................................................................. 8
6.4 Specimen Requirements .................................................................................................. 9
6.5 Equipment ....................................................................................................................... 10
6.6 Reagents ......................................................................................................................... 10
6.6.1 Reagents Required, Reconstitution and Storage ........................................................ 10
6.7 Calibration....................................................................................................................... 12
6.7.1 Using PT Multi-Calibrator ........................................................................................... 12
6.7.2 ISI Input Calibration Curves - Manual entry of ISI value and MNPT ........................... 19
6.7.3 Validating Reagent for Use ........................................................................................ 21
6.8 Quality Control................................................................................................................ 22
6.9 Error Log ......................................................................................................................... 22
7.0 Additional Notes/Comments .................................................................................. 24
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1.0 Purpose and Scope of SOP
The following SOP describes the procedures for the Prothrombin Time assay, also used for INR
calculation on the Sysmex CS-5100 Blood Coagulation Analyser.
2.0 Responsibility
It is the responsibility of the Senior/Chief BMS/Laboratory Manager, along with the Quality
Manager, to ensure implementation and update of this procedure.
It is the responsibility of the Senior/Chief BMS/Laboratory Manager and Training Officer to ensure
competency and training for this procedure.
Staff able to undertake these duties are trained, qualified Biomedical Scientists, and Trainee
Biomedical Scientists under supervision and where stated, suitable trained MLA staff.
Before carrying out this procedure you must have;



Read and understood the laboratory safety guidelines.
Read and understood the Standard Operating Procedure along with the associated health
and safety documentation.
Undertaken any internal associated Competency Assessment necessary.
If there is any part of the SOP which you do not understand, you must discuss this with a senior
member of staff.
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3.0 References
IFU – Sysmex CS-5100
IFU – Siemens Dade Innovin Rev. 06
IFU – Siemens Thromborel S Rev. 06
IFU – Siemens PT-Multi Calibrator Rev 05
4.0 Definitions
BMS
Biomedical Scientist
MLA
Medical Laboratory Assistant
IFU
Instructions for use
PT
Prothrombin Time
INR
International Normalised Ratio
MNPT
Mean Normal Prothrombin Time
ISI
International Sensitivity Index
MSDS
Material Safety Data Sheets
IPU
Information Processing Unit
TAV
Table of Assigned Values
SOP
Standard Operating Procedure
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5.0 Documentation
Electronic copies of the following documentation can all be found on the Sysmex Customer
Portal at www.sysmex.co.uk

Sysmex CS-5100 IFU

Sysmex CS-5100 Software Guide

Sysmex and Siemens material safety data sheets

Sysmex and Siemens Declarations of Conformity

Siemens Reagent IFUs

Siemens Reagent Application Sheets For CS-5100

Siemens Reagents - Certificates of Analysis

Siemens Reagents - Certificate of Traceability

References for Calculating Uncertainty

Specific ISI values for CS-Series
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6.0 Actions and Methods
6.1 Health and Safety
Good laboratory practice dictates that gloves should be worn when handling biological specimens.
If there is a chance of spray or aerosol material then safety goggles should also be worn (for
example; when removing a sample cap, or cleaning up a breakage in the centrifuge). If you have
any doubts about the procedure you are carrying out, you must seek the advice of a senior member
of staff.
The analyser must ALWAYS be run with the light shield down.
The cap-piercing mode uses a sharp probe and care must be taken when opening the cover.
Gloves must be worn and care needs to be taken in order to avoid a needle stick injury when
cleaning the probe.
In the event of exposure to or spillage of chemicals/reagents please refer to laboratory COSHH
assessments and MSDS.
The CS-5100 is connected to an uninterrupted power supply (UPS) and should there be a loss of
mains power the UPS will provide a temporary source of power. When this situation arises there
will be a bleeping sound from the UPS. The UPS will provide power for approximately 15 minutes.
If this occurs then remove all the racks from the analyser that are still waiting to be processed. If
there is a rack in the middle of being processed then this can be left to exit the sampling area as
normal. Wait for the analyser to complete all the tests that it is processing and once the instrument
has returned to the “Ready” state power down the analyser and IPU. Wait for the power to be
restored before powering up the IPU and analyser.
Do not store heavy reagents or consumables on shelves above chest height and be aware of your
posture at all times when carrying out any procedure described in this SOP. Avoid any stooping
posture and ensure a straight back at all times.
When replacing the rinse water it is important that the keg is not completely filled to the top as it
will make it difficult to lift. Use a trolley to transport the rinse kegs, do not carry by hand.
If the liquid waste is connected to a waste container then take carry when handling and emptying
the waste. Use protective clothing (e.g. gloves and safety goggles) when discarding the waste into
a sink/sluice. Use a trolley to transport the waste, do not carry by hand.
If you need to open the light shield the analyser should be in ready state with the green LED lit and
the green “Ready” symbol visible in the bottom left hand corner of the IPU screen. In the event of
an emergency, the red ‘Stop’ button on the front of the analyser can be pressed in order to bring
the instrument to stand-by; this will cause all sample processing to be aborted and allow the main
covers to be opened.
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6.2 Principle of Test
6.2.1 CS-5100 Analyser
The Sysmex CS-5100 coagulation analyser measures the change in transmitted light through the
reaction cuvette during the coagulation process. Light from the halogen lamp is dispersed in 340,
405, 575, 660 and 800 nm wavelengths by five different filters.
Fiber
The spectroscopic light is carried from the lamp unit to the cuvette by an optical fibre where it
shines through the mixture of sample and reagent in a reaction cuvette. The light transmitted
through the mixture at all wavelengths is detected every 0.1 second by the photo diode and is
converted into an electrical signal. The clotting time and the dOD/min (change in optical density)
are derived from this signal by a microprocessor. All detectors can be used for the Clotting,
Chromogenic and Immunoturbidometric assays. Various error flags provide warnings if the assay
kinetics do not meet the set criteria.
A HIL (haemolysis, icterus and lipaemia) check is automatically carried out on each patient plasma
sample (excludes micro mode and QC). Absorbance measurements at 405nm (icterus), 575nm
(haemolysis) and 660nm (lipaemia) are made and this is used to classify the appropriate interfering
substance into 6 judgement levels (0-5) before sample measurement begins. Each judgement level
is distinguished by the range of absorbance. The judgement level can be seen by accessing the
browser screen and selecting the “measurement information” tab. If the sample absorbance is
greater than judgement level 5, a (*) symbol will be shown. The default setting is to output values
with a low reliability flag. If an interfering substance is detected the analyser will continue to process
the sample, however an “H, I or L” will be displayed on the ‘joblist’ in the ‘Sample Info’ column and
a (*) symbol will be attached to the left side of the numeric value.
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6.2.2 Prothrombin Time / INR
Innovin® or Thromborel S® Reagent is used on the CS-5100 coagulation analysers to determine
PT and INR.
Innovin® reagent is prepared from purified recombinant human tissue factor produced in E. coli,
combined with synthetic phospholipids (thromboplastin), calcium, buffers and stabilizers.
Innovin® reagent initiates clotting via the extrinsic and common pathways in a global screening
test, the Prothrombin time (PT) and has three major applications based upon the PT:

Rapid screening test to detect single or combined deficiencies of the extrinsic coagulation
system, indicative of hereditary and acquired coagulation disorders, liver disease or vitamin K
deficiency;

Sensitive monitoring test for oral anticoagulant therapy with vitamin K antagonists;

Assay for specific coagulation factors.
Innovin® Reagent is manufactured using recombinant human tissue factor and synthetic
phospholipids which do not contain any other clotting factors such as prothrombin, FVII and FX.
Therefore, it is highly sensitive to factor deficiencies and oral anticoagulant-treated patient plasma
samples. The sensitivity of Dade® Innovin® Reagent is very similar to the WHO human brain
reference thromboplastin and has an INR close to 1.0.
Innovin® Reagent is insensitive to therapeutic levels of heparin. The high sensitivity of Innovin®
Reagent to coagulation factors and its insensitivity to therapeutic heparin make it beneficial in
monitoring oral anticoagulant therapy with vitamin K antagonists. In addition, its high sensitivity (i.e.
the responsiveness of the reagent to moderately depleted factor activity) allows differentiation of
abnormal plasmas, even in the mildly pathological range.
Thromborel® S Reagent contains lyophilized human placental thromboplastin, calcium chloride,
stabilizers and preservatives.
Thromborel® S Reagent is used for the determination of the PT according to Quick and, in
conjunction with the relevant deficient plasmas, for the determination of the activity of coagulation
factors II, V, VII and X.
The PT measured with Thromborel® S Reagent is a rapid, sensitive screening test for coagulation
disorders in the domain of the extrinsic system (Factors II, V, VII and X). Due to its high sensitivity
for these coagulation factors Thromborel® S Reagent is especially well suited for;

The induction and monitoring of oral anticoagulant therapy.

Diagnosing genetically caused deficiencies in coagulation factors of the extrinsic system.

Diagnosing acquired deficiencies in coagulation factors.

Checking the synthesis performance of the liver in hepatic diseases.
With Thromborel® S Reagent and the relevant deficient plasma, it is possible to determine the
activity of coagulation factors II, V, VII and X.
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According to the joint recommendations of the World Health Organization (WHO) and the
International Committee on Thrombosis and Haemostasis, the PT results for patients on vitamin K
antagonist oral anticoagulants (warfarin) should be reported as INR values. Reported INR results
are independent of the reagents and methods used, and are specifically intended for assessing
patients stabilized on long-term oral anticoagulant therapy.
INR =
[
Patient PT
MNPT
]
ISI
The ISI for the reagent/instrument combination can be found on the IFU included in the Innovin or
Thromborel S packs, or on the Sysmex Customer Portal under Resources/Haemostasis/CS5100/ISI values.
The MNPT can be calculated locally using the geometric mean >20 normal samples.
Alternatively both can be calculated locally using Siemen’s PT multi-calibrator.
Additionally, the CS-5100 coagulation analyser is able to derive a fibrinogen value from the
determination of the PT.
The fibrinogen concentration is derived by analysing the change in optical density during the PT
determination, using a derived fibrinogen calibration curve. This calibration curve (master curve) is
provided by Siemens in the lot dependant table of assigned values included in each reagent pack
or on the Sysmex Customer Portal under Resources/Haemostasis/CS-5100/ISI values.
However, although useful, this derived fibrinogen is not reliable outside the normal reference range;
it often gives slightly elevated levels compared to the Clauss fibrinogen assay and can be
inaccurate in some disease states such as liver disease and also in patients that are anticoagulated.
If the derived fibrinogen value is outside the normal reference range, a Fibrinogen level should be
determined using the Clauss fibrinogen assay.
6.3 Personnel Level of Training Required
All BMS personnel who have had appropriate training may carry out this procedure.
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6.4 Specimen Requirements

The sample required for PT analysis on the CS-5100 analyser is citrated whole blood (1:9
ratio of 3.2% or 3.8% sodium citrate solution to whole blood).

Centrifuge at 1500 x g for no less than 15 minutes at room temperature.

If immediate testing is to be done, the plasma may remain on the packed cells. Otherwise
plasma should be separated from the cells. To separate the plasma, use a plastic transfer
pipette, remove plasma to a plastic tube.

Do not store on ice or at +2 to +8 °C as cold activation of F VII may alter the results.

Plasma containing unfractionated heparin should be centrifuged within one hour of blood
collection, stored at room temperature and tested within four (4) hours.

Non-heparinized plasma should be tested within four hours of blood collection.

Platelet-poor plasma may be frozen at ≤ -20 °C for up to two (2) weeks in a non-frost-free
freezer. Frozen plasma should be rapidly thawed at +37 °C, gently mixed and tested
immediately. Samples should not stand at +37 °C for more than five minutes.
Please refer to CLSI document H21–A5 for detailed information on sample preparation and
storage.

The analysers are run in cap piercing mode which does not require the removal of caps,
but they can also be used to analyse plasma samples pipetted into cups. In the latter
situation, samples may be run in “micro mode” which does not require the aspiration of a
daughter aliquot, thus saving sample volume. Paediatric sample tubes should also be run
in ‘micro mode’ and require a carrier tube to allow a snug fit into the sample racks.

Samples run in STAT mode must have caps removed.

All sample tubes should be clearly labelled with the locally agreed minimum labelling
requirements.
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6.5 Equipment
A Sysmex CS-5100 Coagulation analyser.
The supplier details are as follows:
Switchboard:
Sysmex UK LTD
Sysmex House
Garamonde Drive
Wymbush
Milton Keynes
MK8 8DF
0870 902 9210
Reagent Hotline: 0870 902 9213
Main Fax:
0870 902 9211
Customer Support Centre
Product hotline:
0870 902 9216
Service hotline:
0870 902 9217
6.6 Reagents
6.6.1 Reagents Required, Reconstitution and Storage
Innovin®
B4212-50 (10x10ml) or B4212-100 (12x20ml)
Or Thromborel S
OUHP 29 (10x10ml) or OUHP 49 (10x10ml)
Ci-Trol® Level 1
291070 (10x1ml)
CiTrol® Level 2
291071 (10x1ml)
Ci-Trol® Level 3 (optional)
291072 (10x1ml)
Control Plasma N
ORKE 41 (10X1ml)
alternative to Ci-Trol® Level 1
Control Plasma P
OUPZ 17 (10X1ml)
alternative to Ci-Trol® Level 2
PT Multi-calibrator
OPAT 03 (6x1ml)
CA Clean I
96406313 (1x50ml)
CA Clean II
97405810 (1x5L)
Reaction Cuvettes
06414810 (3000)
4ml cups
EC65.1 (250)
In addition there is a requirement for approximately 20 litres of de-ionised water per day.
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Innovin® Reagent is reconstituted with distilled or deionised water using the volume stated on the
vial label.
Allow time for the vial to reach room temperature (30 minutes) before reconstitution with the volume
of distilled water indicated on the vial label. Mix carefully and leave to stand for 30 minutes at room
temperature. Remix gently before loading onto analyser and allow 15 minutes for the reagent to
equilibrate before use.
Note: Do not use water that contains preservatives.
Store lyophilised reagent at 2-8 °C. At this temperature, the unopened reagent can be used until
its expiry date (see vial label).
Stability after opening: See Reagent insert.
On-board Stability: See Application sheet for CS-5100 analyser.
Do not freeze.
Thromborel® S Reagent is reconstituted with the amount of distilled or deionised water stated on
the vial label and warmed to 37 °C before use. Please note: after reaching 37 °C the reagent must
be incubated at this temperature for 45 minutes, even if it is warmed at another temperature on
certain analysers. Before use the reagent should be mixed carefully. The reagent must be mixed
every 24 hours whilst on board to achieve the stated stability.
Store Thromborel® S Reagent unopened at 2-8 °C and use by the expiry date given on the label.
Stability after opening: See Reagent insert.
On-board Stability: See Application sheet for CS-5100 analyser.
Do not freeze.
Ci-Trol® Level 1, Level 2, Level 3, Control Plasma N and Control Plasma P. Allow time for
the vials to reach room temperature (30 minutes) before reconstitution by adding exactly 1.0 mL of
distilled water to each. Gently tilt the vial to mix and leave to stand for 15 minutes with the vial
closed. Before use, gently mix once more.
Stored at 2-8 °C, lyophilized Ci-Trol® can be used until the labelled expiry date. Do not freeze.
Stability after opening: See Reagent insert.
On-board Stability: See Application sheet for CS-5100 analyser.
Whenever a new batch of Innovin is started, the ISI and MNPT must be changed. If calibrating
locally you will need the PT-Multi Calibrator set which contains 6 plasmas.
Reconstitute the calibrators 1-6 with the amount of distilled water indicated on the label. Allow to
stand for at least 30 minutes at 15-25 °C. Agitate carefully before using (prevent foam formation).
The lyophilised calibrators must be stored at 2-8 °C and may be used up to the expiry date given
on the label.
Stability after opening: See Reagent insert.
On-board Stability: See Application sheet for CS-5100 analyser.
The calibrators may be frozen and thawed again once after reconstitution. They must be frozen as
quickly as possible in the original vials, well-sealed. Thaw in a water bath at 37 °C for a maximum
of 10 minutes. The calibrators must then be used for calibration within 2 hours at 15-25 °C.
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6.7 Calibration
A new calibration curve is required on each change of PT reagent batch.
6.7.1 Using PT Multi-Calibrator
1) Prepare reagents and PT Multi-calibrators and load onto the analyser.
2) Select [Order] followed by [Switch Order].
3) The “Switch Order” dialogue box appears, select [Holder Calib. Curve Order].
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4) Select the [PT Multi] assay group from the bottom of the screen.
5) The “Calibration Curve Order Entry” dialogue box appears. Select the [Change] box and
choose the “Reagent Lot” batch combination required for calibration from the drop down
list. Press [OK].
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6) Click on the [Lot] box, and select the relevant calibrator lot from the scroll box.
Press [OK].
7) If the data has been input using the 2D barcode; the “Assay Sheet Value” will
automatically be populated in the box.
If not, use the keypad to type in the value from the TAV sheet.
Press [OK].
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8) Select the [Regist.] icon.
9) Select [Joblist] to conform the correct assay has been ordered, followed by the [Start] icon
and the calibration will be performed. The joblist will show the progress of the calibration
curve.
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10) Once the calibration curve has completed, Check to see if there are any error or review
messages on the Joblist. If errors or review flags present, troubleshoot accordingly.
11) Select the [Calibration Curve] icon. Press [Change], select Test e.g. [PT Multi], then
choose current lot combination from dropdown list. The following screens will be
displayed:
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12) Check that the calibration curve is acceptable by checking the r value, this should ideally
be 1.00 but a value between 0.996 - 1.00 is acceptable.
13) By selecting the [Detailed Display] icon then select the [Compared Calib. Curve] option, it
is possible to view previous calibration curves for the same lot number or another lot
number against the current calibration curve. The previous curve is displayed in green
and is often hidden directly behind the new curve which is blue.
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14) Once you are ready to accept the new curve, the curve can be validated, by selecting
[Validate]. The dialog box below will be shown.
If you wish the new reagent lot (group) to be available for sample analysis using this new
Calibration curve, tick the checkbox and press [OK].
If you do not wish to introduce this reagent into current use for sample analysis you can
still validate the new Calibration curve but un-tick the checkbox and press [OK]. NB: If
you un-tick this box a “reagent not set” flag will occur if staff try to run with this
reagent.
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6.7.2 ISI Input Calibration Curves - Manual entry of ISI value and MNPT
1) The ISI value can be found on the TAV sheet for the CS-series.
2) Make sure that the new Innovin lot number has been loaded onto the analyser or entered
into Reagent Master using the 2D barcode scanner.
3) From the menu select the [Calib. Curve] icon, then [Change], followed by [PT], then select
the correct reagent combination form the dropdown list. Select the [Edit] button.
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4) In the [Edit Calibration Curve] entry box, enter the ISI value as shown on the TAV sheet
or select [Lot Master] for automatic entry of ISI Value if you have input lot information via
a 2D scanner. Enter the locally derived “Normal Value”.
5) Press [OK] when finished.
6) Press [Validate]. At the [Validation of Calibration Curve] dialogue box make sure that the
“This reagent is used for sample analysis” check box is ticked, then press “OK”.
If you wish the new reagent lot (group) to be available for sample analysis using this new
Calibration curve, tick the checkbox and press [OK].
If you do not wish to introduce this reagent into current use for sample analysis you can
still validate the new Calibration curve but un-tick the checkbox and press [OK]. NB: If
you un-tick this box a “reagent not set” flag will occur if staff try to run with this
reagent.
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6.7.3 Validating Reagent for Use
If you chose not to set the reagent for sample analysis at the time of validation you will need to
modify the reagent settings when you decide to make this reagent available for use.
1) Display the [Reagent] screen
2) Select the reagent holder which contains the relevant reagent i.e. Thrombin
3) Press [Lot Group Settings]
4) Select the relevant parameter tab and tick the checkbox next to the relevant Reagent Lot
(Group), press [OK].
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6.8 Quality Control
See CS-5100 SOP - QC.
It is essential that all lyophilised controls are reconstituted as described in the respective IFU and
left for the stated time and temperature prior to running on the CS-5100. Failure to follow these
instructions may lead to incorrect results.
Ci-Trol® 1 / Control Plasma N and Ci-Trol® 2 / Control Plasma P should be run for the PT assay
at least twice a day and with every reagent vial change. If the lamp is changed, or any repairs are
carried out on the CS-5100 analysers, such as a change of probe, tubing or pumps then the
controls should be run again.
QC can be run from either the sample rack or from within the instrument.
6.9 Error Log
Depending on the error, if there are any problems with the analyser then it will generate an audible
alarm and the “Error Help” screen will appear (the message column can be widened to display the
whole message if it is not showing).
Message Board
Action Message
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The message board will contain a list of all of the errors that have occurred today along with the
time. The most recent error message will be at the top of the list. When you highlight an error
message the “Action Message” box on the lower half of the screen will provide suggestions in order
to resolve the problem.
It is worth looking at the times of the error messages underneath the most recent/last error
message. On occasions an error message may be caused by a sequence of actions leading to a
range of error messages. In this instance the problem is more likely to have been caused by the
first error in the sequence of error messages.
1) A comment regarding the action taken to rectify the problem can be added by selecting
[Log Corrective Action].
2) Select the appropriate corrective action or select [Direct Entry] to add a free text comment,
click [OK] once done.
3) Error messages can be viewed by clicking the [Warning symbol] at the bottom of the IPU
screen.
If all the error messages have been acknowledged then this symbol will appear white.
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The [Log Corrective Action] icon can be used to record corrective actions for previous
error message in order to ensure the warning triangle returns to the white icon.
4) Click the [Error Log] button to show a list of all the errors that have occurred on the
analysers.
There is a detailed table of Corrective action for errors in the CS-5100 Instructions for Use.
7.0 Additional Notes/Comments
It is essential that the sample is filled to the correct fill level, any sample which is over filled or under
filled should not be processed. The CS-5100 has the ability to detect under and over-filled samples.
If the sample volume check is enabled then the sample will be flagged when these conditions have
been triggered.
Grossly haemolysed, grossly lipaemic samples and samples with clots should be rejected. The
CS-5100 has the ability to detect haemolysis, icterus and lipaemia. If this functionality is activated
then samples will be flagged when these conditions are triggered.
Results of tests should always be interpreted in conjunction with the patient’s medical history,
clinical presentation and other findings.
Many commonly administered drugs may affect the results of the prothrombin time. This should be
kept in mind especially when unusual or unexpected abnormal results are obtained.
Innovin reagent is insensitive to concentrations of unfractionated heparin up to approximately 2.0
units per ml.
Hirudin or other direct thrombin inhibitors in therapeutic doses can result in prolonged PT.
Inhibitors such as lupus anticoagulants may interfere with the PT and result in INR values that do
not reflect the exact dose of anticoagulation.
The derived fibrinogen obtained from the PT, often gives slightly elevated levels compared to the
Clauss assay and can be inaccurate in some disease states such as liver disease and also in
patients that are anti-coagulated.
Unexplained abnormal APTT/PT results should always be followed by additional coagulation
studies to determine the source of abnormal results.
Should there be any problem with the analyser it will alarm and the error Help screen will appear.
The message column can be widened if the whole message is not showing.
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Sysmex UK Ltd
Sysmex House,
Garamonde Drive.
Wymbush
Milton Keynes,
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