CoaguChek Pro II Professional Monitoring System · The CoaguChek Professional Meter (CoaguChek Pro II) quantitatively determines prothrombin time (“PT”), using arterial blood,

CoaguChek® Pro II Professional Monitoring SystemTraining Manual

© Roche Diagnostics 2016. For Healthcare Professional use only.

4143 CoaguChekPro-II_TrainingManual_Final.indd 1 1/31/17 2:17 PM

CoaguChek Professional Training folder v1.0

Information obtained from:CoaguChek Pro II Operators Manual version 2.0CoaguChek PT Test strip pack insert 2016-05 v1.0 CoaguChek XS PT Test strip pack insert #580 (2010)-RPD-B 322-Frau Frank

© Copyright 2016. Roche Diagnostics Limited. All rights reserved.COAGUCHEK and ‘BECAUSE IT’S MY LIFE’ are registered trademarks of Roche.

Roche Diagnostics Ltd. Charles Avenue, Burgess Hill, RH15 9RY United Kingdomwww.coaguchek.co.ukCompany registration no: 57154608

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CONTACT AND ORDER DETAILSPage 7

SYSTEM INTRODUCTIONPage 11

INTERFERENCESPage 17

TRAININGPage 23

CLEANINGPage 33

TROUBLESHOOTINGPage 41

APPENDIX 1Page 45

APPENDIX 2Page 61

APPENDIX 3Page 71


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CoaguChek Professional Monitoring Systems Training Manual 7

Roche Diagnostics Contact Information

UK Main Switchboard: 01444 256000

Freephone UK Customer Services:0808 100 9998

UK Technical Support: 0808 100 1920

Ireland Main Switchboard: +44 (0) 1444 256000

Freephone Ireland Customer Services:1 800 509 586

Ireland Technical Support: 1 800 409 564

Roche DiagnosticsCharles AvenueBurgess HillWest SussexRH15 9RYEngland

CoaguChek Pro II Professional Meter ConsumablesCat. No’s for CoaguChek Consumables:

CoaguChek PT Test Strips x 48 (2 x 24) 06688721019

CoaguChek PT Controls (Level 1 & 2) 06679684190

Safe-T-Pro Plus Single Use Device x 200 03603539150

Battery Pack 06869904001

There is a handling fee for orders under £100

Enter your CoaguChek Pro II Professional Meter serial number here:

Account Specialist Name and Number:

Local Contacts:




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CoaguChek Pro II Professional MeterSystem Introduction

The CoaguChek Professional Meter (CoaguChek Pro II) quantitatively determines prothrombin time (“PT”), using arterial blood, capillary blood or whole blood from a vein (non-anticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

The CoaguChek Pro II meter has the ability to connect wirelessly to a data management system (DMS) after initial set up through the Handheld Base Unit from Roche. The meter supports data exchange via POCT1A standard. Data management systems may have the ability to expand the security features of the meter, such as enabling operator lockouts. Data management systems may also enable data transfer to a LIS or HIS.


12 CoaguChek Professional Monitoring Systems Training Manual

CoaguChek Pro IIPictorial Guide

A Touchscreen Shows test results, information, icons and

results recalled from memory. To select an option, simply touch the button lightly.

B On/Off button Press this button to power the meter

on or off.

C Test strip guide cover Remove this cover to clean the test strip

guide (if it has become soiled, e.g., with blood).

D Test strip guide Insert the test strip here.

E Barcode scanner The integrated barcode scanner can scan

operator, patient, and QC sample IDs into the meter.

F Battery compartment cover Remove to insert the battery pack.

G Charging terminals Used for power supply and/or charging the

battery pack, when the meter is docked in the (optional) Handheld Base Unit.

H Code chip slot (shown with code chip)

Insert the code chip here.

I Connection socket for power adapter Plug in the power adapter here.

J Infrared interface (Covered by the semi-transparent panel)

Supports data communication.



CoaguChekIntended Use

The CoaguChek PT Test is an in-vitro assay for the determination of prothrombin time (PT) using the CoaguChek Pro II meter. The test can be used with either capillary, venous, or arterial fresh whole blood.

Field of ApplicationThe CoaguChek PT Test can be used:• for the determination of the prothrombin time in patients suspected

deficiencies of coagulation factors of the extrinsic and common pathway, with the exception of fibrinogen

• for monitoring of patients on oral anticoagulant therapy with vitamin K antagonists

Test PrincipleElectrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant tissue factor. Each test strip has a test area containing a prothrombin reagent. When blood is applied, the reagent is dissolved, and an electrochemical reaction takes place which is transformed into a clotting time value. The clotting time value is displayed on the meter screen either in INR, seconds or % Quick.

ReagentThe test strip contains human recombinant tissue factor as activator, bulk materials, stabilizers, preservatives and additives.

Figure - Position of electrodes and reagent on the test strip:



CoaguChekMeasurement terms

Prothrombin time (PT) and International Normalised Ratio (INR) are parameters used to measure the activity of oral anticoagulation therapy on the clotting ability of patient blood. Below is a short explanation of the terms most frequently used in the training session.

Prothrombin Time (PT)Thromboplastin is added to blood to activate coagulation; this causes a blood clot to form. The time taken to produce the clot is measured in seconds (secs) and is known as the Prothrombin Time.

Either venous or capillary blood samples can be used to monitor anticoagulation therapy.

International Sensitivity Index (ISI)As not all laboratories use the same reagents and equipment, differences in results were observed. In 1983 the World Health Organisation (WHO) launched a scheme where all thromboplastins used are compared against a known WHO standard preparation.

Every manufacturer of Thromboplastin must calibrate it against the WHO standard and the deviation from this standard is measured. The value obtained is known as the International Sensitivity Index.

The ISI is obtained by comparison of the log PT results of 20 normals and 60 patients stabilized on anticoagulant therapy tested with the local PT against the manual PT tests with the same plasmas using the WHO international reference preparation.

The ideal thromboplastin has an ISI of 1.

International Normalised Ratio (INR)INR is the globally recommended unit for the measurement of Prothrombin time. INR makes the comparison of results possible, despite the difference in thromboplastins and equipment used.

An INR value is calculated from the clotting time of the patient blood sample, divided by the clotting time of a normal, healthy patient. This is known as the Prothrombin Ratio (PTR). To neutralize the affects of the different thromboplastins, the PTR is multiplied by the power of the ISI of the thromboplastin used.

INR = (Patients PT / Mean Normal PT)ISI


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CoaguChekLimitations - Interferences

Important Note – The test interferences below are subject to change therefore always refer to the test strip pack insert for full details and up to date information

The blood drop must be a minimum of 8µL in volume. Low sample volume will cause an error message.

Testing performed with the following in vitro spiked samples or native blood samples (Triglycerides) indicated no significant effect on test results.

• Bilirubin up to 513 µmol/L (30 mg/dL)

• Haemolysis up to 0.62 mmol/L (1000 mg/dL)

• Haematorcrit ranges between 15 % and 55 %

• Tryglycerides up to 11.4mmol/L (1000 mg/dL)

• Ascorbic Acid - up to 50mg/L

• The CoaguChek PT Test is insensitive to low unfractionated heparin (uFH) and low molecular heparin concentrations (LMWH) up to 3IU/mL blood

CoaguChek and Anti-phospholipid antibodies (APA)The presence of Lupus antibodies (antiphospholipid antibodies: APA) may lead to an increase in INR that leads to false high INR values. The extent and the frequency of such false and high INR measurements depend on the type and amount of APA. This varies between Lupus patients. Some patients do not show an influence on their INR, others have a prolonged INR, and again others only get error messages. This may vary over time in an individual as the amount of APA increases or decreases over time.

Clinical investigations to prove effects are hard to perform, therefore even when a study provides us with some information on the influence of Lupus antibodies on the CoaguChek Pro II system, it will not allow us to predict the effect for an individual patient or population.

It is recommended to measure with the CoaguChek Pro II system and an APA insensitive lab reagent several times in parallel to see if the values are reliable. If the difference is acceptable, the patient could potentially use the CoaguChek Pro II system to monitor INR levels. If the difference is unacceptable, we do not recommend using the Pro II system, even when the difference is acceptable at some but not all time points. Please keep in mind that APA may vary in concentration over time, therefore, a control measurement with a lab reagent is recommended to be done at regular intervals to guarantee the reliability of the CoaguChek system values.



The Hughes Syndrome Foundation are a registered UK charity aiming to provide information about Hughes Syndrome (antiphospholipid syndrome: APS). Their website provides information about the charity and all aspects of Hughes Syndrome for patients, doctors and supporters. They have a section on treatment and monitoring of INR by patients themselves with self-testing INR machines, and we would recommend contacting them for any advice on this subject.

www.hughes-syndrome.org



WarfarinInterferences

Important Note – The interferences below are limited, and subject to change. For a complete list of interferences refer to appropriate documentation for example the British National Formulary

The action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.g. antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza). This, in turn, can also lead to either an increase or a decrease in prothrombin time (INR). Additional medication should only be taken if prescribed by a health care professional. If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted as directed by the health care professional.

Change in a patient’s clinical condition, particularly associated with liver disease, intercurrent illness, or drug administration, necessitates more frequent testing. Major changes in diet (especially involving salads, vegetables as well as generally eating foods that are rich in vitamin K) and in alcohol consumption may also affect anticoagulant control.*

*www.evidence.nhs.uk/formulary/bnf/current/a1-interactions/list-of-drug-interactions/anticoagulants/coumarins/warfarin [accessed July 2014]




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CoaguChek Pro II Professional Meter Training Checklist

Name:

Location:

Location:

Date:

1. Safety Information:

Contra-indications

Test Interferences

2. Meter Knowledge:

Meter Setup

Touch screen & Navigational Buttons Scanner

Window & How to Use Scanner

Battery & Base Unit

Strip Port

Display, Reading Range & Error Codes

Operator ID & Patient ID

Access of Stored Data

3. Test Strips:

Code Chip Calibration Expiry Date

Handling & Insertion of Test Strip

Application of Sample

Adding Comments

4. Internal/External Quality Control:

Internal Quality Control Policy

When/Other Times to Quality Control

Preparing & Running Quality Control

What to do if Quality Control Fails

Quality Control Lockout & Stat Test External Quality Assurance

Expiry Dates



5. Patient Preparation for a Test:

Consent

Infection Control – Nurse & Patient

Sample Types

Sites & Method for Obtaining a Capillary Sample

Correct Application & Amount of Sample

Consequences of under-dosing the Test Strip

Reading & Documentation of Results

Disposal of Consumables

6. Cleaning & Storage of Meter/Consumables:

Cleaning of Meter

Decontamination of Meter

Correct Storage Conditions for Meter & Consumables

7. Supplies:

Test Strips, Operator Manual

Quality Control Solutions, Lancing Devices

8. Troubleshooting & Advice:

Point of Contact for any Meter Problems

Signature of Trainer

Signature of Trainee



CoaguChek Pro IIPatient Testing

If the function Operator ID is active then log in as the operator and touch ‘Patient Test’. If the function Operator ID is inactive, from the Main Menu, touch ‘Patient Test’.

If prompted scan the Patient ID or enter via touch screen then touch .

Remove a test strip from pot and insert into meter when prompted.

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P-ID: PID01Smith, Henry

Op: Operator 1Par: PT

Test 09:15 am

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P-ID: PID01

Code: 184

3:00 Min.

Smith, HenryOp: Operator 1Par: PT

Test 09:15 am

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P-ID: PID01

Code: 184


If prompted insert code chip. The meter finds the code chip information and warms the strip then displays a 3 minute countdown.

Lance the patient’s finger. Exercise precautions required for handling all blood specimens. Operators must wear disposable gloves when collecting blood samples or performing tests.

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Test 09:15 am

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P-ID: PID01

Code: 184


QC

Test 09:15 am

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P-ID: PID01

Code: 184


Test 09:15 am

05/29/2015

P-ID: PID01

Code: 184

2.5INR


21%Q

05/29/2015 09:14 am

The patient should then apply the drop of blood to the test strip using top or side dosing, within 15 seconds of lancing finger.

Wait for the meter to beep and start to analyse the sample then remove the finger. The meter will automatically test the on-board QC.

The result is displayed. Comments can be added by touching .

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,

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CoaguChekIQC and EQA Guidelines

This section provides detail on the quality control systems available as an integral part of the CoaguChek systems, and quality assurance processed that are available from third party providers. It is intended as a guide to help with the management of a quality control process, and assist with meeting regulatory compliance requirements as applicable to the end user.

Please note also that quality control recommendations by national associations or local hospital guidelines take precedence over manufacturer recommendations.

Internal quality controls (IQC) and external quality assessment (EQA) are two components of a quality assurance programme. IQC is used to ensure consistency of INR results over a period of time. EQA is used to identify the degree of agreement between INR results in different centres.

IQC for the CoaguChek Pro II SystemsThe CoaguChek Pro II has a number of built in quality control functions:

• A check of the electronic components and functions every time the meter is powered on

• A check of the test strip temperature while a test is in progress

• A check of the expiry date and lot information on the test strip based on the code chip data

• A two-level, on board quality control test and patient result determination within a single test chamber

The CoaguChek PT Test stripsThe CoaguChek PT Test strips also have built in quality control functions:

• The reagents integrity is checked on each strip on the same channel that the sample goes through.

• Strips are refused which are exposed to:

• High temperature

• Humidity

• Light

• (or any combination of the above)



The CoaguChek PT ControlsCoaguChek PT Controls are used for system checks and quality control testing of prothrombin time with the CoaguChek Pro II system and CoaguChek PT Test strips. The CoaguChek PT Controls are intended for use by professional users.

The CoaguChek PT Controls are an optional product that can be used to ensure compliance with quality control recommendations by national associations or local hospital/laboratory guidelines.

Recommended frequency for use of CoaguChek PT ControlsIf CoaguChek PT Controls are used, please find below recommended frequency of use. These are only suggestions for when to use controls and are therefore not mandatory.

• When introducing a new lot of CoaguChek PT test strips

• Monthly, or before a large clinic

• If there is any doubt about the storage conditions for the CoaguChek PT Test strips

• If there is an unexpected INR result, or an error occurs after sample application (we would firstly recommend a retest in this situation to rule out any poor sample quality issues).

EQA for the CoaguChek SystemsIt is recommended that the participation in an accredited EQA programme, such as the UK National External Quality Assessment Scheme (NEQAS) or the Wales External Quality Assessment Scheme (WEQAS), is the best option for fulfilling EQA needs. This type of scheme involves regular distribution of sample which are tested on the CoaguChek Pro II system and the results returned for comparison with other centres using the same device.



CoaguChek Pro IIQuality Control Testing

Main Menu 09:15 am

05/29/2015

Control Test

Review Results

Setup

Patient Test

QC Test 09:15 am

05/29/2015

Op: SchulzPar: PT

QC Test 09:15 am

05/29/2015

QC 070

QC 060

QC 050

New Code

QC 048

Scan

Remove plastic cap and rubber bung.

Touch ‘Control Test’.

Ensure no liquid is in the end of pipette and carefully cut end off and empty all contents into glass vial, ensuring not to touch the powder. Exercise normal precautions when handling laboratory reagents.

Insert test strip when prompted and test strip code chip (if prompted).

Replace the black cap and swirl on desktop (do not shake), until all the powder has dissolved. The solution is now stable for 30 minutes.

Check lot number on side of QC bottle then select from list, or select ‘New’.

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1.2 INR

78 %Q

05/29/2015 09:15 am

QC: 999Code: 184Op: Operator 1

Par: PTLevel: 1

(1.0 - 1.4 INR)

(53 - 99 %Q)

Pass:

If ‘New’ option selected, insert QC code chip when prompted or select ‘Scan’ and scan the side of the QC bottle using the barcode.

Once the 3 minute countdownstarts, apply the solution to thetest strip using the pipette.

The sample will be analysed and the result and acceptable range displayed on the screen.

7 8 9QC Test 09:15 am

05/29/2015

Code: 184Op: Operator 1

Par: PT

QC




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CoaguChek Pro II Professional MeterCleaning Guide

This section is intended to be an aid to cleaning the CoaguChek Pro II Professional Meter. Cleaning information from the User Manual and/or test strip pack inserts should always be followed in the first instance.

• Observe the disinfection guidelines of you institution.

• Use gloves.

Follow the instructions given below to clean and disinfect the meter. Failure to follow these instructions may cause malfunction of the meter.

Instrument damage due to moistureEnsure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument.

• Do not spray anything onto the meter housing.

• Do not spray into the test strip guide

• Do not immerse the meter in liquid.

• Do not use cloths or swabs/buds that are saturated.

Squeeze off excess solution or blot on a dry paper towel to remove any excess solution before wiping the surface of the meter.



Recommended cleaning/disinfecting solutionsUse only the following solutions for cleaning/disinfecting the meter (housing and test strip guide).

• A soft cloth slightly dampened (not wet) with a small amount of liquid soap diluted in water

• Rubbing alcohol (70% ethanol or isopropyl alcohol)

• Alcohol-based disinfectant (a mixture of 1-propanol (400 mg/g), 2-propanol (200 mg/g) and glutaraldehyde (1.0 mg/g))

• 10% sodium hypochlorite solution (1 part bleach to 9 parts de-ionized water, made fresh every 24 hours)

• Disposable wipes contanining quarternary ammonium compounds up to 0.5% (single compound or mixture) in isopropyl alcohol (isopropanol) up to 55%

NOTICE Do not use any other disinfectants/cleaning solutions on the meter (housing or test strip guide). Use of other disinfectants/cleaning solutions could result in damage to the meter.



Cleaning/disinfecting the exterior (meter housing)

Use the solutions recommended above for cleaning/disinfecting the meter exterior. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labelling). Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing.

1. Power off the meter. Then gently wipe over the surfaces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet).

1. Power off the meter. Then gently wipe over the surfaces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet).

Do not let liquid accumulate near any opening. Ensure that no liquid enters the meter. 2. With a fresh dry cloth or lint-free tissue, wipe away residual moisture and fluids after cleaning

the housing. Visually verify that no solution is seen anywhere on the housing or touchscreen at the completion of cleaning and disinfecting.

3. Allow wiped areas to dry for at least 10 minutes before performing a test. If you notice streaks on the housing or touchscreen, or the touchscreen surface becomes slightly cloudy, wipe clean immediately with a soft, lint-free cloth slightly dampened with water. Cleaning/disinfecting the test strip guide Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labelling). Using lint-free cotton swabs/buds. 1. Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the

test strip guide by pressing its front edge upward.) Move the cover safely away from the meter.

Do not let liquid accumulate near any opening. Ensure that no liquid enters the meter.

2. With a fresh dry cloth or lint-free tissue, wipe away residual moisture and fluids after cleaning the housing. Visually verify that no solution is seen anywhere on the housing or touchscreen at the completion of cleaning and disinfecting.

3. Allow wiped areas to dry for at least 10 minutes before performing a test.

If you notice streaks on the housing or touchscreen, or the touchscreen surface becomes slightly cloudy, wipe clean immediately with a soft, lint-free cloth slightly dampened with water.



Cleaning/disinfecting the test strip guide

Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labelling). Using lint-free cotton swabs/buds.

1. Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward.) Move the cover safely away from the meter. Then rinse the cover with warm water or wipe it clean using the solutions recommended above. Let the test strip guide cover dry for at least 10 minutes before re-attaching it.

2. Hold the meter upright with the test strip guide facing down.

• Clean the easily accessible white areas with a moistened cotton swab/bud.

• Ensure the swab/bud is only damp, not wet. Wipe away residual moisture and fluids.

NOTICE Damage to the instrument Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. Do not insert any objects in the test strip guide. Doing so may damage the electrical contacts behind the test strips guide.



On completion of cleaning:

3. With the cover off, let the test strip guide dry for at least 10 minutes before re-attaching the test strip guide cover and testing again.

• Visually verify that no residual moisture is seen anywhere on the test strip guide and cover at the completion of cleaning and disinfecting.

• Ensure that the test strip guide and cover are completely dry before assembling them.

4. Re-attach the test strip guide cover to the housing. Make sure that the cover is properly closed. You will hear it snap in place.




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CoaguChek Pro II Professional MeterTroubleshooting

The CoaguChek Pro II meter continually checks its system for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors.

Depending on the circumstances, a message may appear on the display of the meter.

These messages are marked with an icon, either

CoaguChek Troubleshooting

The CoaguChek XS Plus and XS Pro meters continually check their systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for a status message, or for an error message. All messages displayed by the system are accompanied by a description of the error and a possible solution. Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Technical Support. The two different message types are illustrated below:

Additional information on Error 406

for a status message, or for an error message. All messages displayed by the system are accompanied by a description of the error and a possible solution.

Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Technical Support.

The two different message types are illustrated below:

CoaguChek Troubleshooting

The CoaguChek XS Plus and XS Pro meters continually check their systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for a status message, or for an error message. All messages displayed by the system are accompanied by a description of the error and a possible solution. Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Technical Support. The two different message types are illustrated below:

Additional information on Error 406



Additional information on E-406

Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. Do not touch or remove the test strip when a test in in progress.

Note on Error 406: The CoaguChek XS PT Test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections. For maximum heparin concentrations which do not interfere with the test, refer to the package insert for the test strip. Under no circumstances, however, should heparinized capillary tubes be used for sample application. Be sure to apply the blood drop to the test strip within 15 seconds of lancing the fingertip. In rare cases, patients with long clotting times (> 8 INR) may receive an “Error 406” message on the meter display. If this error message appears again when the test is repeated, the result must be checked using another method.

Always consult the CoaguChek XS Plus or Pro user manual, and contact Roche Technical Support if you are unsure of how to correct an error, or if you are unsure if your CoaguChek is working correctly.

Roche POC Technical Support tel: 0808 100 1920 (UK), 1 800 409 564 (Ireland)

Roche POC Technical Support email: [email protected]

Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. Do not touch or remove the test strip when a test in in progress.

Note on E-406: The CoaguChek PT Test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections. For maximum heparin concentrations which do not interfere with the test, refer to the package insert for the test strip. Under no circumstances, however, should heparinized capillary tubes be used for sample application. Be sure to apply the blood drop to the test strip within 15 seconds of lancing the fingertip. In rare cases, patients with long clotting times (> 8 INR) may receive an “E-406” message on the meter display. If this error message appears again when the test is repeated, the result must be checked using another method.

Always consult the CoaguChek Pro II user manual, and contact Roche Technical Support if you are unsure of how to correct an error, or if you are unsure if your CoaguChek Pro II is working correctly.

Roche POC Technical Support tel: 0808 100 1920 (UK), 1 800 409 564 (Ireland)Roche POC Technical Support email: [email protected]


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An example Protocol for an Oral Anticoagulation Clinic © UNIVERSITY OF BIRMINGHAM, November 2009

Protocol developed by Ellen Murray & David Fitzmaurice, Department of Primary Care & General Practice, University of Birmingham.

Acknowledgements We would like to thank the following who undertook peer review of this protocol. Dr Patrick Kesteven, Fiona Dobson, Dr Will Lester

Updated 25/5/2014 Ellen Murray



2

Aim The service will offer equitable, standardised and clinically effective anticoagulation management for patients receiving anticoagulation therapy.

Objectives • To receive, manage and ensure appropriate referral of patients who

require anticoagulation therapy either registered or non registered in the practice (To include novel oral anticoagualtion thersapy where appropriate)

• To ensure all patients have a treatment plan reviewed on a regular basis (annually)

• To identify patients with specific needs, i.e.poor compliance, unstable INR control or frequent non-attenders for review by designated clinician

• To educate new and review patients in understanding their treatment, in terms of their condition requiring anticoagulation, target range for INR, the effects of over and under anticoagulation, diet, lifestyle and drug interactions

• To advise on anticoagulant therapy regimen prior to surgery or dental care (BCSH guidelines)

• To provide optimum care in accordance with the NPSA guidelines in terms of:

• 1.INR control, e.g. 60-70% of individual patients’ INR tests in range at any given time

• 2.Identifying and managing clinical events related to anticoagulation therapy

• 3.Considering the impact of patient choice (patient satisfaction questionnaire annually e.g. accessibility, waiting time, and continuity of care

• To ensure safe and accurate recording of all clinical data using the relevant CDSS system with relevant back up documentation in case of electrical breakdown

• To evaluate the quality of care given through regular audit process, effecting change when required to achieve planned goals.

• To ensure relevant, complete and accurate documentation of the clinic process.

• To undertake an annual review and update of the protocol.

Specific objectives for primary care only • To initiate and manage anticoagulation therapy for patients with

atrial fibrillation in the general practice clinic.



3

Capacity

All patients receiving anticoagulation therapy referred to the clinic

Exceptions (primary care) • Patients under 16 years of age

• Patients with complex pathologies following discussion with specialist e.g. atypical systemic emboli, anything not listed under routine indications for anticoagulation.

• Pregnant patients

• Domiciliary patients (although practices will need to make a decision regarding patients requiring home visiting they are the group that would most benefit from primary care services)

• Patients choosing to continue with hospital / primary care

Exclusions (nurse led in acute care) Patients with complex pathologies whose management is beyond the competence of the nurse

Indications for warfarin use & target INR The indications and targets are taken from British Society of Haematology guidelines Baglin T, Keeling D, Watson H. Guidelines on oral anticoagulation (warfarin): third edition – 2005 update BJ Haem 2005; 132: 277-285

Other targets will be acceptable for named patients after discussion with responsible clinician.

Target INR 2.5

Pulmonary embolus

Proximal DVT

Calf vein thrombosis

Recurrence of venous thromboembolism

Non-rheumatic atrial fibrillation

Atrial fibrillation other causes

Mural thrombus

Cardiomyopathy

Symptomatic inherited thrombophilia

Antiphospholipid syndrome

Bioprosthetic valve if anticoagulated

Arterial grafts if anticoagulated Mechanical prosthetic aortic valve (or 3.0)

Cardioversion (or 3.0)

Target INR 3.5

Recurrence of venous thromboembolism whilst on Warfarin therapy

Mechanical prosthetic valve (or 3.0)

Not indicated

Ischaemic stroke without AF

Retinal vein occlusion

Peripheral arterial thrombosis and grafts

Coronary artery thrombosis

Coronary artery graft thrombosis

Coronary angioplasty & stents



4

Risk management Assess risk to both patient and health care professional

Implement risk reduction strategies incorporated into the clinic management,e.g.

1. Patients lost to follow up

2. Inadequate or lost referrals

3. Inadequate documentation

4. Inadequate updated staff training

5. Point of care failure

6. Insufficient clinic time/space for appointments education and discussion

7. Inappropriate dose and monitoring interpretation

8. System computer network failure

9. Health and safety , blood spillage, cross contamination

Implementation of risk reduction strategies must be done with reference to relevant clinical governance authorities where appropriate.

Management of clinic • Allocate protected time per week for clinic andt availability for

emergency services other days

• Inform hospital/primary care clinics currently managing patient of new clinic.

• Train a nurse in anticoagulation management to manage the clinic with support from a designated clinician.

• Estimate the INR using a Point of Care (POC) device. • Interpret the INR result with the assistance of computerised decision

support software (CDSS.

• Perform internal quality control at the start of each clinic and after every 20 INR tests using material supplied by the manufacturer.

• Perform external quality control every three months using samples from an external quality assessment scheme eg:, NEQAS.

• Adhere to health and safety procedures recommended by laboratory staff to protect both the patient and clinical staff at all times.



5

Suggestions for manual recall periods in case of CDSS breakdown

One high INR greater than or equal to 5 – recall 7-14 days

One high INR greater than or equal to 6 – recall within 5 days

One low INR 1 unit below target– recall 7-14 days

One therapeutic INR - recall 2-4 weeks

Two therapeutic INRs – recall 6 weeks

Three therapeutic INRs – recall 8 weeks

Four therapeutic INRs – recall 10 weeks

Five therapeutic INRs – recall 12 weeks

Identify key personnel Establish effective routes of communication between some of the following:

• Haematologist / Anticoagulant nurse specialist nurse (named)

• Lead general practitioner (named)

• Lead Practice nurse (named)

• Laboratory contact (named)

• Anticoagulant clinic contact (named)

• Pharmacist

• ICT personnel

• Administrator



6

Training The clinic will be managed by trained staff - designated users.

Personnel responsible for the clinic must be aware of professional accountability and undertake the clinic management only if they feel competent to do so.

Accredited courses are available. Personnel managing the clinic will also be aware of continued professional development and attend regular updates on anticoagulation management.

A patient group direction may be utilised in acute situations e.g. over anticoagulation, or where urgent supply of warfarin to a patient is warranted.

If independent prescribing by nurses and pharmacists is to be undertaken their names must be annotated on their professional registers to indicate successful completion of recognised prescribing training.

Training should include: • An introduction to oral anticoagulation therapy, an understanding of

the test to be performed, the INR and how it is derived

• An understanding of specific POC device for deriving INR, setting up and using the device

• The target INR, how it relates to diagnosis, action if results outside limits

• Management of VKA therapy based on INR results and management of other anticoagulation therapy

• Recording of results and quality assurance materials.

• Health and safety - disposal of sharps, Control of Substances Hazardous to Health (COSHH) regulations.

Standard operating procedures will be needed when using POC devices I Identification & referral of patients Referrals from other clinics or specialists.

For primary care - the practice computer database will identify most patients. In addition patients can be identified from anticoagulation therapy prescriptions. Regular computer searches (every 3 months) will check for new patients to the practice receiving anticoagulation.

Hospital/primary care anticoagulant clinics will need to be informed of all patients attending other clinics. A letter should be sent to the hospital/primary care clinic to inform them if another clinic is going to take over the anticoagulation monitoring. A referral letter should include clinical indication, recommended period on anticoagulation and target INR. An example referral form is shown in Appendix 1.

Telephone referrals cannot be accepted unless under exceptional circumstances.



7

All patients will remain the responsibility of the referring centre until the patient is seen in the clinic.

For patients moving to a new practice, hospital clinics will be informed if patients need to be referred back to the hospital clinic. The same referral form will be used attached to a referral letter with a copy to the patient and new GP if known.

• (Primary care) Patients can attend the practice clinic once their INR has been within therapeutic range on two occasions. At this point the hospital clinic can discharge the patient into GP care if appropriate arrangements have been made. (Acute thromboses. Other conditions may be referred on discharge)

Clinic procedure for patients receiving warfarin

• Prepare POC device and complete internal quality control procedure. Document control result, batch numbers of strips and controls, user ID

• Counsel patient regarding clinic process and check for:

Ê Bleeding or thrombotic events

Ê Tablet compliance and change of medication

Ê Lifestyle changes e.g. alcohol binges

• Perform blood test using capillary blood. Venous samples can be taken at patient request or for capillary results greater than POC upper limits.

• Perform INR test using POC device and enter results into the decision support software.

• Follow suggestions given by computer for dosing and recall dates unless clinically inappropriate e.g. patient known to be non compliant with therapy.

• Complete patient record card and give to patient with verbal instruction regarding dosage and recall.

• Record INR, Warfarin dosage and recall date in patient’s notes and practice computer.

Annual review • Assess condition requiring anticoagulant – risk / benefit - annual

specialist or clinician follow up, check recommended period of time on anticoagulant

• Assess whether anticoagulant therapy is still appropriate e.g. dementia, multiple ADRs

• Assess patient satisfaction using a simple questionnaire (see Appendix 2



8

Haemorrhagic risk assessment (Beyth) Score 1 each that apply

Age >65

History of stroke

History of gastrointestinal bleed

One or more of:

• Recent MI

• Diabetes

Score 0 – low bleeding risk 2-3% in the first year

Score 1-2 Intermediate risk of bleeding in the first year

Score 3 -4 High risk of bleeding in the first year

New patients • Review treatment plans of all new patients, ensure all patient details

are entered and correct in both yellow record book and referral letter and patient is given information sheets and record book.

• Ensure that patient has correct target range, duration of treatment for condition requiring anticoagulant. If not, referring clinician should be consulted.

• Educate about anticoagulant treatment, target range, effects of over and under anticoagulation, diet, lifestyle and drug interactions.

• Explain the clinic system with regard to blood testing, dosing and next test date.

Clinical guidelines for initiation of Warfarin Patients having Warfarin initiated for AF in the community should have a baseline INR performed. Warfarin should only be initiated if the baseline INR is less than 1.3. Any patient with a baseline INR of 1.3 or above should be screened for underlying conditions. Check FBC, LFTs, clotting screen.

The initiation dose for patients commencing Warfarin for AF in the community should be 1- 3mg daily. Check INR after one week and then weekly until INR within therapeutic range and then dose according to result using CDSS.



9

BSH guidelines for INR greater than 5.0

3.0 < & < 6.0 (target 2.5) Reduce or stop Warfarin, restart when INR < 5.0

4.0 < & < 6.0 (target 3.5) Reduce or stop Warfarin, restart when INR < 5.0

6.0 <& < 8.0 - No bleeding or minor bleed Stop Warfarin, restart when INR < 5.0

INR > 8.0 - No bleeding or minor bleeding. Admit to hospital for Vit K 0.5mg or GP for IV Vit K 0.5 mg or oral Vit K 0.5 – 2.5 mg.for partial reversal

Major bleeding Stop Warfarin; admit to hospital for urgent reversal (prothrombin complex concentrate/FFP) and iv Vit K 5-10mg.

Definition of serious and non serious adverse events

Serious adverse event • Bleeding: if admitted to hospital or if surgery was required to stop

bleeding and if bleeding led to reduction of Hb of 2 g/dL or more and /or requiring blood transfusion1

• Thrombotic: Transient Ischaemic Attack (with observed neurological deficit) or Stroke, recurrent Deep Vein Thrombosis and Pulmonary Embolism, Systemic Embolism.

Non serious • All cases of bleeding with no associated costs or medical

consequences, e.g. bruising, small epistaxis, microscopic haematuria.

Advice to patient having dental treatment Patients are advised to continue with Warfarin therapy when attending for dental treatment. However, they will need to check their INR the day before the appointment to ensure the INR is below 4.0.

1 Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D’Angelo A et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996; 348: 423 - 428



10

Pre-operative management of Warfarin If major surgery - stop Warfarin 4 days before surgery, heparin introduced pre-op in hospital

If minor surgery - reduce INR to approximately 2.0 on day of surgery (Liaise with hospital to discuss Warfarin dosage on discharge)

Guidelines for discontinuing Warfarin To discontinue Warfarin at treatment completion, obtain written confirmation from clinician that commenced Warfarin therapy. The end date of treatment should be clarified on original referral form.

Administrative Tasks Perform a weekly computer search for non-attendees to Warfarin clinic.

Contact non-attendees to the clinic with a letter/ telephone call and a new appointment.

Produce and send patient satisfaction questionnaire

Undertake referrals to other clinics as necessary

Undertake stock control as necessary

Arrange protocol and clinical meetings as necessary

Ensure training of key personnel is up to date

Forward anticoagulant therapy cards of moved away patients to designated GP or re-refer to hospital anticoagulant clinic if necessary.

Perform a backup of software at the end of each clinic.

Audit (Safety indicators) To be performed at least annually, reviewed and changes made where needed.

• INR results in terms of percentage time in range and point prevalence

• Mean INR and mean anticoagulant dose

• IQC and EQA results

• Adverse events in terms major and minor events - defined according to previously accepted criteria descibed above

• Patient satisfaction

• Numbers attending the clinics

• Attendance rate and waiting time

• Patient complaints

(See NPSA report for further parameters)



11

Clinic procedure for novel anticoagulants There are currently NICE technology appraisals available for stroke prevention in atrial fibrillation for

dabigatran, rivaroxaban, and apixaban

Technology appraisals suggest that they should be made available for patients who require them but

that the decision on choice of agent should be undertaken only following an informed discussion with

the individual patient.

In addition, rivaroxaban and dabigatran are licensed for the treatment and secondary prevention of

venous thromboembolism.

Dabigatran is a direct thrombin inhibitor which works by inhibiting the action of thrombin, and so

prevent the conversion of fibrinogen to fibrin. The advantages of thrombin inhibitors are that their

pharmacokinetics are predictable and they can be taken orally without regular monitoring of a patient’s

INR and the activated partial thrombin time (APTT).

It is licensed in the UK for for non-valvular atrial fibrillation, treatment and secondary prevention of

venous trhromboembolism and for prophylaxis for knee and hip replacements.

For stroke prevention in atrial fibrillation, patients who would be considered for warfarin should be

considered for dabigatran.

Dose

Daily dose of Dabigatran of 300 mg, taken as one 150 mg capsule twice daily for patients with AF

This dose should be reduced for patients aged 80 years or older to a daily dose of 220 mg, taken as

one 110 mg capsule twice daily, because of the increased risk of bleeding in this population.

For patients aged 75–80 years, consider a dose of 220 mg taken as one 110 mg capsule twice daily

for individual patients whose thromboembolic risk is low and bleeding risk is high.

Starting Dabigatran

It has a half life 12 -17 hours and the onset of effect starts shortly after dosing , maximum

anticoagulant effect achieved within 0.5 – 2 hours.

There is no need to give LMWH for atrial fibrillation

Rivaroxaban is a factor Xa inhibitors which works by inhibiting factor Xa, but allows residual

thrombin to carry out its other important functions.

Rivaroxaban is licensed for non-valvular atrial fibrillation, treatment and secondary prevetnuon of

venous trhromboembolism and for prophylaxis for knee and hip replacements.



12

For stroke prevention in atrial fibrillation, patients who would be considered for warfarin should be

considered for rivaroxaban

Dose 10 mg once daily dose – fixed

Starting Rivaroxaban

Initial dose should be taken 6 – 10 hours after surgery and for major hip surgery 5 weeks treatment

recommended.

Major knee surgery 2 weeks is recommended

There is no need to give LMWH

Apixaban is another factor Xa inhibitor also taken orally and is licensed for thromboprophylaxis for knee and hip surgery and also for non-valvular atrial fibrillation. Dose 2.5mg taken twice a day There is no need to give LMWH

For stroke prevention in atrial fibrillation, patients who would be considered for warfarin should be considered for apixaban Procedure before starting novel anticoagulants Check :

1. Renal function - egfr 2. INR, PT, APPT 3. Liver function tests 4. Review concomitant meds – interactions verapamil

The patient can be switched from warfarin when INR is 2.0 or below See Appendix 3 for suggested care pathway



13

Declaration This protocol has been developed on behalf of the PCT by:

Lead Doctor Signed Date

Lead Pharmacist

Lead Nurse

Head of Primary Care

Quality Control

Consultation with:



14

Appendix one

Anticoagulation Clinic Referral Form

Patient Name: Date of Birth:

Address:

Telephone number:

GP Referral

Yes ! No !

If Yes, provide name of GP practice

Consultant Referral

Yes ! No !

If Yes, provide name of consultant hospital

Clinical condition requiring anticoagulant:

Target and range:

Concurrent medical conditions:

Concurrent medications

Date anticoagulant commenced:

Length of treatment: End date:

Current dose: Previous INR results:

Signature of clinician: Date:


APP

END

IX 2




Accuracy and precision in oral anticoagulation monitoring

“I know my value”

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There is a natural variation in the response of patients towards anticoagulation therapy with vitamin K antagonists (VKAs). One study has shown that biological variation of the International Normalized Ratio (INR) within patients treated with VKAs is between 9.1 % and 10.9 % (coefficient of variation [CV], in %).1

In addition to this natural variation, which cannot be influenced, measurement deviations can also be caused by external factors. These can lead to differences between measure-ments from different laboratories or between measurements performed with the Coagu-Chek® system and the lab. These deviations may be due to different sensitivities of the rea-gents used, different pre-analytics methods, or variations in the calibration of laboratory reagents (determination and consideration of the deviation of a reagent/instrument to a reference).2

Figure 1 shows an example of differences in coagulation values obtained using different measurement methods.

Theoretically, coagulation values can be reported as either % Quick, seconds or INR units.

The use of INR allows direct comparison of measured values, because the reagents used for measuring the prothrombin time (PT) are calibrated by a well-defined procedure and designated with a specific index called the International Sensitivity Index (ISI).4 The ISI value indicates the degree of compliance to World Health Organization (WHO) reference thromboplastin, whereby an ISI of 1.0 means that the reagent has the same sensitivity as reference thomboplastin.4

Due to the lack of standardisation, % Quick values measured with different reagents can-not be compared. Societal guidelines, such as those issued by the American College of Chest Physicians (ACCP),5 provide recommendations based upon INR values. Patients are provided with a target INR range by their physician, and ideally their measured INR should stay within this therapeutic range for as long as possible in order to reduce the risk of vascular events and major hem orrhage. However, coagulation values measured in INR units are still susceptible to measurement deviations caused by external factors.

Coagulation measurements can vary for different reasonsINR allows for direct comparison of measured values

CoaguChek XS

Innovin Recombiplastin

Thrombotest

Neoplastin plus

Hepato Quick

Thromboplastin C Plus

Min Max Diff (maxmin)

2.1 2.40 2.33 1.99 2.25 2.25 2.40 1.99 2.40 0.42

2.5 3.02 2.78 2.91 2.68 3.00 2.89 2.50 3.02 0.52

3.0 3.56 3.00 2.76 3.18 3.09 3.25 2.76 3.56 0.80

Fig. 1: INR values obtained using different measurement methods (CoaguChek XS and different laboratory thromboplastins) within a defined INR range of 2.0 – 3.0. Source: Roche Diagnostics GmbH, CoaguChek XS Evaluation Study3

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This data is produced with the CoaguChek XS, but results and conclusions are expected to be equivalent with CoaguChek Pro II.



The use of INR allows directcomparison of measured valuesbecause reagents are calibrated

by a well-defined procedure anddesignated with an ISI value

that indicates the degree ofcompliance to WHO reference

thromboplastin4

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The use of INR allows directcomparison of measured valuesbecause reagents are calibratedby a well-defined procedure and

designated with an ISI valuethat indicates the degree of

compliance to WHO referencethromboplastin4


The causes of measurement deviations can generally be assigned to three categories: dif-ferences in the sensitivities of the reagents; pre-analytics errors; and calibration errors.2

I) Reagent sensitivityA high degree of comparability between INR values is achieved through calibration and standardisation to ISI. However, the reagents have different sensitivities to the activities of the clotting factors that are influenced by VKAs. Experience has shown that reagent sensi-tivity is heavily dependent on various factors:· The source of thromboplastin used (e.g. rabbit, bovine or human)6

· Phospholipids contained in the thromboplastin (e.g. natural mixture or synthetically produced)7

· The reagent composition (e.g. with/without stabilisers and/or glycine; an aqueous or dry chemical substance)6

· The sample (e.g. whole blood or plasma, undiluted or diluted)8

Each reagent is unique – there are no two reagents with absolutely the same properties. Even two WHO reference thromboplastins show a certain degree of deviation, which is larger for higher INR values (Figure 2).

Three external factors can contribute to measurement deviationsReagent sensitivity, pre-analytics, and calibration

Fig. 2: Comparison of two reference thromboplastins (rTF/95 and CRM 149S). Source: Roche Diagnostics GmbH, CoaguChek XS Evaluation Study;3 n = 273

10

9

8

7

6

5

4

3

2

1

0

CR

M 1

49S

(tilt

tube

) [I

NR

]

0 1 2 3 4 5 6 7 8 9 10

rTF/95 (tilt tube) [INR]

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II) Errors in preanalyticsPre-analytics includes all steps that are performed prior to measurement using a point-of-care (POC) system (e.g. CoaguChek) or in the laboratory. Several sources of error can affect measurement results at these steps.

Experience has shown that when measuring with the CoaguChek system, attention must be paid to the following:· The puncture site should be sufficiently dried if it had been disinfected with alcohol· Hands should be sufficiently dried after washing and dried if sweaty (e.g. due to fear of

pricking)· The time elapsed between pricking and sampling should not be too long· If an additional measurement is required, blood should be taken from a different

puncture site· The finger should not be excessively squeezed around the puncture site. This increases

the risk of contamination and false results due to thromboplastin from the tissue

Venous blood samples to be used in laboratory tests also show a number of potential error sources:9

· Secondary venous access (e.g. back of hand). Blood sampling from the back of the hands or feet is generally more difficult than obtaining a fingerprick blood sample and can lead to coagulation activation, for example if repeated pricking occurs

· Wrong needle size. If the needle diameter is too small, this can lead to activation of coagulation, especially in case of rapid withdrawal of the sample

· Venous stasis due to blocking of blood circulation for too long· Incorrect sampling tubes, wrong sequence of blood collection· Wrong blood volume leading to false citrate/blood ratio (tubes must be at least 80 % full)· Insufficient mixing of sample· Too high proportion of platelets due to inappropriate centrifugation· Impairment of sample stability, improper storage (activation of factor VIIa)· Hemolytic, lipemic or coagulated samples· Evaporation of the sample caused by long queuing in the automated analyser

III) Errors in the calibration of laboratory reagentsManufacturers of laboratory reagents provide an ISI for their reagent lots, which is based on a specific reagent-analyser combination. Most users have no way to check the specified ISI or to determine it for their system. At both levels – manufacturer or user calibration – experience has shown that there are several potential sources of error.· The mean normal value, in seconds, which is used by the laboratory to calculate the

INR, may change or may have been determined incorrectly· Deviations may occur when laboratory reagents need to be recalibrated, thereby

changing the ISI· Deviations can be caused by different calibration methods



In general, INR differences between POC devices such as CoaguChek® systems and laboratory systems are of the same order of magnitude as those observed between various laboratory systems 10

Experience has shown that measure-ment deviations are generally observed between different coagulation measure-ment systems, independently of whether POC or laboratory

6 1/20/2015 8:49:46 AM

In general, INR differences between POC devices such as CoaguChek® systems and laboratory systems are of the same order of magnitude as those observed between various laboratory systems10

Experience has shown that measure-ment deviations are generally observed between different coagulation measure-ment systems, independently of whether POC or laboratory

61/20/2015 8:49:46 AM4143 CoaguChekPro-II_TrainingManual_Final.indd 66 1/31/17 2:17 PM


In general, INR differences between POC devices such as CoaguChek systems and labora-tory systems are of the same order of magnitude as those observed between various labo-ratory systems.10 There are no specific measurement differences between the CoaguChek system and the laboratory. Measurement deviations are generally observed between differ-ent coagulation measurement systems, independently of whether POC or laboratory.

The following points generally apply to measurement deviations:· Deviations are more common in patients with unstable anticoagulation, in whom coagu-

lation factors are even more variable. In addition, the likelihood of measurement differ-ences is increased further by different reagents sensitivities

· In general, the higher the INR, the greater the possible deviations may be:11 · INR below 2.5: possible deviation 0.1 – 0.3 INR· INR 2.5 – 4.5: possible deviation 0.5 – 1.0 INR· INR above 4.5: possible deviation 1.0 – 2.0 INR

· In cases of differences between values obtained using laboratory systems and Coagu-Chek devices, check whether a systematic offset exists between the CoaguChek device and the specific laboratory. A systematic measurement offset against one laboratory method does not mean that the measured value offset will exist against other laboratory methods

· It should be noted that for patients taking VKAs with previously stable therapeutic INRs who present with a single out-of-range INR of ≤0.5 below or above therapeutic, recent guidelines suggest continuing the current dose and testing the INR within 1 to 2 weeks12

· In case of unclear readings, it is advisable to not change between systems

INR differences between CoaguChek and the laboratory are normalBetween-laboratory measurement differences are of similar magnitude

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7 1/20/2015 8:49:57 AM

11











The CoaguChek® XS systemProviding patients and their physicians with quality, reliable results

Calibrated to WHO guidelines for reliabilityCoaguChek XS PT test strips are manufactured with a human recombinant tissue factor and have been assigned an ISI of 1.015 according to the WHO guidelines for thromboplastins and plasmas used to control anticoagulant therapy.4 The validity of the CoaguChek XS calibration concept has been demon-strated16 and is explained in Figure 4.

Excellent performance: high correlation, high accuracy and high precisionThe performance of the CoaguChek XS system has been verified in a study conducted at four study centres, using venous and capillary blood samples on two CoaguChek XS PT Test Strip lots.13 Labora-tory testing was performed on frozen plasma samples with six commercial thromboplastins. Results were assessed using a refined data set of 260 subjects according to the International Organization for Standardization (ISO) 17593:2007 standard.14

• High correlation. For patient samples in the therapeutic range (INR 2.0 – 4.5), each of the two test strip lots met the ISO acceptance limits of ± 0.3 INR (bias –0.19 to 0.18 INR)

• High accuracy. For patient samples with an INR ≤4.5, more than 97 % of all INR differences to a refer-ence thromboplastin were found within the combined ISO acceptance limits of ± 0.5 INR or ± 30 %

• High precision. For patient samples with an INR ≤4.5, the CV for INR imprecision ranged from 2.0 % to 3.2 % in venous blood testing, and from 2.9 % to 4.0 % in capillary blood testing (all upper confi-dence limits of the CVs were <4.5 %)

In another study, a 4-year examination of External Quality Assessment (EQA) for INR tests using CoaguChek XS and CoaguChek XS Plus systems indicated that the quality of results as indicated by inter-site variability is similar among POC sites as for hospital laboratories.10

Fig. 4: (a). A master lot of test strips is directly calibrated by comparison with international reference preparations (IRP) and represents the manufacturer’s working standard. (b). Further calibration in routine manufacturing of test strips is performed versus this master lot using whole blood samples from patients on oral anticoagulation and from normal donors.18 INR: International Normalized Ratio; IPTcorr: instrument PT (clotting time measured by the system corrected for hematocrit)

INR Calibration according to WHO reference method INR Calibration of the production lots

Blood sample Blood sample

Algorithm Lot specific information

Code Chip

CoaguChek XS Master Lot

CoaguChek XS Production Lot

IPTcorr (sec) IPTcorr (sec)

IRP manual tilt tube* CoaguChek XS Master Lot

INR INR

(a) (b)

*For details of the manual tilt tube method, see Poller

10 1/20/2015 8:50:00 AM

12

13

14

15

17

*For details of the manual tilt tube method, see Poller (1998)16



Equivalent performance across all CoaguChek XS systemsEquivalence has been demonstrated between INR results determined using the CoaguChek XS system and INR results determined using the CoaguChek XS Plus system.19 For three test strip lots, the maxi-mum mean bias between the CoaguChek XS system and the CoaguChek XS Plus was 0.03 INR for samples below an INR of 2.0, and 0.07 INR for samples in the therapeutic range of oral anticoagulation therapy (INR 2.0 – 4.5).19

The equivalence of the CoaguChek XS Pro and CoaguChek XS Plus systems has also been demon-strated over the whole hematocrit range, meeting the acceptance criteria for all blood samples.20

Additional quality featuresThe CoaguChek XS system also has the following additional features to ensure outstanding quality:• Integrated Quality Control system. A separate chemical pathway detects deterioration of the strip

chemistry due to exposure to humidity, heat, or light.18 As a result, no liquid quality control is need-ed in a CLIA-waived environment

• Hematocrit correction. INR results are corrected for hematocrit within the range of 25 – 55 %, allowing a broad range of patients to be measured with one device18

• Hemolysis insensitivity. INR results are insensitive to hemolysis up to 1,000 mg/dL21

• Heparin insensitivity. Test strips include an anti-heparin agent that has been added to neutralise the effects of heparin found in blood samples applied to the test strip. INR results are unaffected by unfractionated heparin up to 1 U/mL and LMW heparin up to 2 U/mL18

In summary, the CoaguChek XS system from Roche provides patients and their physicians with accurate and precise INR testing through careful calibration to international standards, ensuring quality, reliable results every time.

11 1/20/2015 8:50:06 AM

18

18

19

17

17

17

20

Equivalent performance across all CoaguChek XS systemsEquivalence has been demonstrated between INR results determined using the CoaguChek XS system and INR results determined using the CoaguChek XS Plus system.19 For three test strip lots, the maxi-mum mean bias between the CoaguChek XS system and the CoaguChek XS Plus was 0.03 INR for samples below an INR of 2.0, and 0.07 INR for samples in the therapeutic range of oral anticoagulation therapy (INR 2.0 – 4.5).19

The equivalence of the CoaguChek XS Pro and CoaguChek XS Plus systems has also been demon-strated over the whole hematocrit range, meeting the acceptance criteria for all blood samples.20

Additional quality featuresThe CoaguChek XS system also has the following additional features to ensure outstanding quality:•Integrated Quality Control system. A separate chemical pathway detects deterioration of the strip

chemistry due to exposure to humidity, heat, or light.18 As a result, no liquid quality control is need-ed in a CLIA-waived environment

•Hematocrit correction. INR results are corrected for hematocrit within the range of 25 – 55 %, allowing a broad range of patients to be measured with one device18

•Hemolysis insensitivity. INR results are insensitive to hemolysis up to 1,000 mg/dL21

•Heparin insensitivity. Test strips include an anti-heparin agent that has been added to neutralise the effects of heparin found in blood samples applied to the test strip. INR results are unaffected by unfractionated heparin up to 1 U/mL and LMW heparin up to 2 U/mL18

In summary, the CoaguChek XS system from Roche provides patients and their physicians with accurate and precise INR testing through careful calibration to international standards, ensuring quality, reliable results every time.




APP

END

IX 3





Multicenter evaluation of the CoaguChek® Prothrombin Time (PT) Test on the CoaguChek® Pro II meterWhite paper

1 12/9/2016 4:10:48 AM

© Roche Diagnostics 2016. For Healthcare Professional use only.





White Paper: Multicenter evaluation of the CoaguChek® Prothrombin Time (PT) Test on the CoaguChek® Pro II meter

2

Contents

Summary .....................................................................................................................................................................................................................3

Introduction ..............................................................................................................................................................................................................4

Intended use .............................................................................................................................................................................................................4

Fields of application ...........................................................................................................................................................................................4

Enhanced features of the CoaguChek Pro II system compared with other CoaguChek systems ........................5

Study data ..................................................................................................................................................................................................................6

Method comparison with reference methods .........................................................................................................................................6

Fig. 1. Passing–Bablok regression analysis of INR values for the CoaguChek Pro II system compared with the Siemens Dade Innovin PT test .........................................................................................................................6

Sensitivity in patients with documented coagulation deficiencies .................................................................................................7

Repeatability study ..............................................................................................................................................................................................7

Table 1. Repeatability of INR values and PT values in seconds measured with the CoaguChek PT Test strip on the CoaguChek Pro II meter ...................................................................................................................................7

Intermediate precision and reproducibility study ..................................................................................................................................7

Table 2. Intermediate precision and reproducibility of INR values determined with the CoaguChek PT Test strip on the CoaguChek Pro II meter across four study sites combined ......................................7

Sample matrix comparison study .................................................................................................................................................................8

Table 3. Sample matrix comparison for capillary and arterial blood versus venous blood using the CoaguChek aPTT Test strip on the CoaguChek Pro II meter ....................................................................8

Interfering substances ......................................................................................................................................................................................8

User performance evaluation .........................................................................................................................................................................8

Conclusions ................................................................................................................................................................................................................8

CoaguChek Pro II meter and CoaguChek PT Test strip specifications .................................................................................9

References .............................................................................................................................................................................................................. 10




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Summary Rapid and reliable determination of the prothrombin time (PT) and international normalized ratio (INR) is vital in a wide range of clinical scenarios. The CoaguChek Pro II is the latest addition to the CoaguChek point-of-care (POC) coagulation systems from Roche. The CoaguChek Pro II system uses the new CoaguChek PT Test strip which has a broader intended use compared with the predecessor CoaguChek XS PT Test strip. This external validation study evaluated the analytical performance of the CoaguChek PT Test on the CoaguChek Pro II meter and compared this performance with an approved laboratory method.

All study endpoints were successfully met. INR values measured on the CoaguChek Pro II system demonstrated excellent correlation to those measured on the Sysmex® CA-1500 laboratory reference analyzer using the Siemens® Dade® Innovin® PT reagent (Pearson’s r = 0.98) with very low bias (relative mean difference 0.2%). The CoaguChek Pro II system delivered INR values and PT values in seconds with high precision. The pooled coefficient of variation (CV) in the repeatability studies with venous patient samples was 3.3% for INR and 2.3% for PT in seconds. Intermediate precision using CoaguChek PT controls was excellent (< 3.0% CV).

Test results were comparable when measured in either venous or capillary blood. Similar results were seen with arterial samples, though only a few of these samples were available for analysis. There was no evidence of systematic interference on the CoaguChek PT Test strip with any of the potential interferents analyzed.

These data confirm that the CoaguChek Pro II system delivers reproducible and laboratory-comparable PT/INR test results and validate its use at the Point of Care.




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IntroductionClinical situations often demand fast and accurate assessment of a patient’s coagulation status. This is particularly important in emergency and acute care settings. An increasing number of patients worldwide with conditions including atrial fibrillation, deep vein thrombosis, and pulmonary embolism are treated with oral anticoagulation therapies such as Vitamin K antagonists (VKA) to reduce the risk of abnormal blood clots developing.1 There are also groups of patients who present with hereditary or acquired deficiencies in coagulation factors of the extrinsic and common pathways. Many of these individuals have an elevated risk of bleeding compared with those with normal coagulation function. Tests such as the PT/INR and the activated partial thromboplastin time (aPTT) are established methods for investigating coagulopathies and contribute vital information to clinical decision-making based on an individual’s coagulation status.2 In acute care settings such as the emergency department (ED), intensive care unit (ICU), or operating room (OR), POC coagulation testing provides test results in real time and enables multidisciplinary care teams to make immediate, informed treatment decisions.

The PT test is a global assay of the extrinsic and common coagulation pathways.3 It is commonly used to detect inherited and acquired coagulation disorders, to assess liver function, to evaluate hemostasis in bleeding patients and prior to invasive procedures in selected patients, and to monitor VKA therapy.2,4–7

For over 20 years CoaguChek systems from Roche have set the standard in POC coagulation monitoring, delivering fast and accurate PT/INR test results — whether through patient self-testing or testing by healthcare professionals at the Point of Care. The CoaguChek Pro II system from Roche is optimized for use within acute care settings and now offers both the PT/INR and aPTT tests on a single POC system. Each CoaguChek PT Test strip lot is pre-calibrated against the World Health Organization (WHO) reference method ensuring accuracy of the test results. The PT/INR values are provided within approximately one minute.

Intended use The CoaguChek Pro II system (comprised of the CoaguChek Pro II meter, the CoaguChek PT Test and CoaguChek aPTT Test strips) is used for the determination of PT and aPTT by healthcare professionals in a point-of-care environment.

The CoaguChek PT Test is an in vitro assay for the determination of PT using the CoaguChek Pro II meter. The test can be used with either capillary, venous, or arterial fresh whole blood.

Fields of application The CoaguChek PT Test is a one-step coagulation test using human recombinant tissue factor as an activator.

The CoaguChek PT Test can be used:

• for the determination of the PT in patients with suspected deficiencies of coagulation factors of the extrinsic and common pathway, with the exception of fibrinogen

• for monitoring of patients on oral anticoagulant therapy with VKAs




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Enhanced features of the CoaguChek® Pro II system compared with other CoaguChek® systems The CoaguChek Pro II system offers multiple enhancements over the CoaguChek XS Plus and CoaguChek XS Pro systems, including a broader operating temperature range and an extended test menu.

The CoaguChek XS PT Test was optimized to be insensitive to levels of unfractionated and low molecular weight heparin (LMWH) up to 3 IU/mL, and is now called the CoaguChek PT Test. The CoaguChek PT Test has a wider intended use compared with the CoaguChek XS PT Test: the CoaguChek Pro II system can be used to determine PT in patients with suspected deficiencies of coagulation factors of the extrinsic and common pathways, with the exception of fibrinogen. The system also supports VKA therapy monitoring in hospital and outpatient settings including anticoagulation clinics and physicians’ offices. Both the CoaguChek PT and aPTT Test strips deliver accurate results across a broad hematocrit range (15 – 55%) ensuring fast and reliable assessment of coagulation status in individuals with low hematocrit values, such as anemic patients and those in the ICU.

The CoaguChek Pro II system has enhanced connectivity compared with other CoaguChek systems for professional use. Built-in Wi-Fi connectivity allows test results to be immediately transmitted from the meter to the dedicated data management system or a patient’s electronic health record via the wireless local area network (WLAN) and compatible middleware. Hence vital information is available in real time at every Point of Care, eliminating transcription steps, thereby reducing the possibility of human error, and streamlining workflow.

Using the first-in-market QR code feature for POC coagulation systems, a test result on the CoaguChek Pro II meter can be converted into a QR code which is compatible with the relevant data management system’s requirements, be it plain text, coded data or data transmitted via a URL. This QR code can then be scanned using either a barcode reader or any smart device (e.g. a tablet or a smart phone) scan app, and transmitted to the data management system, making test results immediately accessible to healthcare professionals who can then make appropriate treatment decisions in real time.




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Study dataThe performance of the CoaguChek PT Test on the CoaguChek Pro II meter was verified in a study performed at four external clinical sites.† Testing was conducted using fresh whole blood samples from patients representative of the European adult population with an indication for the assessment of coagulation status who were recruited from different clinical settings (the ED, ICU, hematology center, and OR).

Method comparison with reference methods The CoaguChek PT Test on the CoaguChek Pro II meter demonstrated excellent correlation with the Siemens Dade Innovin PT laboratory reference test (Pearson’s r = 0.98 for both INR [Figure 1] and PT in seconds). All CoaguChek INR values, and 98% of CoaguChek PT values in seconds, were within ± 25% of Innovin INR/PT values across the tested INR range. The relative mean difference of INR values between tests was 0.2%. The relative mean difference for PT values in seconds was higher (10.1%) as expected due to the lack of standardization of this unit.

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Fig.1. Passing–Bablok regression analysis of INR values for the CoaguChek Pro II system compared with the Siemens Dade Innovin PT test (all sites combined excluding outliers; n = 256; slope 0.99; intercept 0.01; Pearson’s r = 0.98)

†1. Med. Versorgungszentrum IMD GmbH, Gerinnungspraxis Mannheim, Mannheim, Germany (Principal Investigator [PI] Prof. Dr. Carl-Erik Dempfle); 2. Universitätsklinikum Heidelberg, Medizinische Klinik IV, Gastroenterologie, Heidelberg, Germany (PI Dr. Anita Pathil-Warth); 3. Vienna Hospital Association, Allgemeines Krankenhaus-Universitätskliniken, Notfallmedizin, Vienna, Austria (PI Univ. Prof. Dr. Anton Laggner); 4. Krankenhaus St. Vinzenz Zams, Innere Medizin, Zams, Austria (PI Dr. Hans Robert Schönherr).

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Sensitivity in patients with documented coagulation deficienciesTwenty-four patients from site 1 had documented coagulation factor deficiencies. The PT values measured in these patients’ samples on the CoaguChek Pro II system demonstrated very good concordance with the laboratory reference test. All results were equivalent when both the 97.5th percentile of a reference population and 1.5-fold the mean normal value were used as cut-offs to define positive and negative results with the two tests. These data demonstrate that the CoaguChek PT Test on the CoaguChek Pro II meter has a comparable sensitivity to the Siemens Dade Innovin PT test for detecting patients with coagulation factor deficiencies.

Repeatability study The distribution of INR values reflected the clinical settings from which the patients were recruited, with most showing low INR values (Table 1). For all patients combined the pooled CV for INR values was 3.3% and 2.3% for PT in seconds. The pooled CVs for INR values and PT values in seconds across the different INR ranges were also low (< 3.6% and < 2.4%, respectively).

CoaguChek® PT (INR) CoaguChek® PT (sec)

na Mean %CVpool (95% CI) Mean %CVpool (95% CI)

All sites combined 68 1.54 3.3 (2.8, 4.0) 18.5 2.3 (2.0, 2.8)

INR ≤ 1.2b 42 1.05 3.6 (3.0, 4.6) 12.6 2.4 (2.0, 3.0)

INR 1.3 – 1.9b 19 1.63 3.0 (2.3, 4.4) 19.6 2.4 (1.8, 3.5)

INR ≥ 2.0b 7 4.22 2.0 (1.3, 4.3) 50.7 1.9 (1.2, 4.2)

Repeatability was analyzed in two runs on six CoaguChek Pro II systems resulting in 12 replicates per sample; a n is the number of series (68 in total from 55 patients; some patients were tested twice on different test strip lots); b INR range was determined using the CoaguChek Pro II system. CI, confidence interval.

Table 1. Repeatability of INR values and PT values in seconds measured with the CoaguChek PT Test strip on the CoaguChek Pro II meter

Intermediate precision and reproducibility study Intermediate precision and reproducibility with CoaguChek PT controls was excellent with low CVs for both the Level 1 and Level 2 controls (Table 2).

CoaguChek® control level n Mean INR

Intermediate precision Reproducibility

SD %CV (UCI) SD %CV (UCI)

Level 1 336 1.3 0.0 3.0 (3.2) 0.0 3.2 (3.6)

Level 2 336 3.0 0.1 2.3 (2.4) 0.1 3.1 (4.1)

Intermediate precision and reproducibility was determined using CoaguChek PT Level 1 and Level 2 controls according to guidelines from the Clinical and Laboratory Standards Institute (CLSI EP5-A2).8 Controls were measured over 21 days in two runs per day using two or three lots of CoaguChek PT Test strips. Data from all four sites were combined. SD, standard deviation; UCI, upper confidence interval (one-sided 95% CI).

Table 2. Intermediate precision and reproducibility of INR values determined with the CoaguChek PT Test strip on the CoaguChek Pro II meter across four study sites combined




8

Sample matrix comparison study There was no difference in INR values and PT values in seconds when measured with the CoaguChek Pro II system in either venous or capillary whole blood samples. The relative mean difference for both coagulation units was low (< 0.5%), indicating that either sample type can be used with the CoaguChek Pro II system. Similar results were seen for arterial samples compared with venous samples; however, only a low number of these samples were available for analysis.

Comparison

CoaguChek® PT (sec) CoaguChek® PT (INR)

na RMDb (95% CI) RMDb (95% CI)

Capillary vs. venous 66 0.2 (–1.0, 1.5) 0.4 (–0.5, 1.4)

Arterial vs. venous 13 0.4 (–2.6, 3.5) 0.4 (–1.0, 1.7)

a n is the number of patients; b RMD, relative mean difference in percent. Table 3. Sample matrix comparison for capillary and arterial blood versus venous blood using the CoaguChek PT Test strip on the CoaguChek Pro II meter

Interfering substances

Levels of electrolytes (sodium, chloride), bilirubin, triglycerides, fibrinogen, platelets, and hematocrit were determined in patient samples and plotted against the deviation of PT in seconds measured on the CoaguChek Pro II system versus the Siemens Dade Innovin PT test. None of the tested interferents significantly impacted on the CoaguChek PT Test results. In all cases the bias difference between the CoaguChek PT Test and the Siemens Dade Innovin reference test at the highest and the lowest interference concentration was below 22%. INR values measured on the CoaguChek Pro II system were unaffected by hematocrit values in the tested hematocrit range of 18.9 to 51.4%.

User performance evaluationOperators participating in this study completed a questionnaire to evaluate the usability of the CoaguChek Pro II system. Overall, the operators rated the ease of handling of the CoaguChek Pro II meter as good, with the majority of users agreeing that performing a test on the system was easy.

ConclusionsAll endpoints were successfully met in this study, validating the analytical performance of the CoaguChek PT Test on the CoaguChek Pro II meter. The CoaguChek Pro II system provides INR values and PT in seconds with very high reproducibility and generates results that are comparable to the Siemens Dade Innovin PT test used as the reference laboratory method. PT/INR test results provided by the CoaguChek Pro II system are unaffected by the sample type used.

In a limited population of patients with documented coagulation factor deficiencies, the CoaguChek PT Test strip had comparable sensitivity to that of the Siemens Dade Innovin PT laboratory reference test.

The CoaguChek Pro II meter with the CoaguChek PT Test strip can be used by healthcare professionals to obtain immediately actionable coagulation results at all Points of Care. Whether this is to determine if a patient has a coagulation factor deficiency of the extrinsic or common pathways or for monitoring VKA therapy, the CoaguChek Pro II system delivers reliable information when and where it is needed the most.




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CoaguChek® Pro II meter and CoaguChek® PT Test strip specifications

Measuring and sampling

Detection system Amperometric (electrochemical) determination after activation of the blood coagulation with human recombinant thromboplastin

User interface Full graphical (thin-film-transistor)

Support and safety functions QC lockout, patient & user ID, protection with administrator ID, 2D barcode scanner

Sample application Outside the meter, with top- and two sides (left or right)-dosing options

Operating conditions

Operating temperature +12 to +32°

Operating humidity and altitude 10 – 85%; 4,300 m (14,000 ft)

Handling Operating the meter: on a level, vibration free surface, in a roughly horizontal position

Measuring range PT/INR: 0.8 – 8.0; %Quick: 120 – 5; seconds: 9.6 – 96

Memory 2,000 patient and 500 QC results with date and time120 code chip records (60 strip codes & 60 control codes)Operator list with up to 5,000 operator IDs with corresponding 2nd ID e.g. operator namePatient list with up to 4,000 patient IDs with corresponding 2nd and 3rd patient IDs e.g. name, date of birth

Interface Touch screen and barcode scanner

Power options Universal battery pack for the CoaguChek Pro II meterPower supply adapter: input: 100 – 240 V / 50 – 60Hz / 350 – 150 mA; output: 12 V DC / 1.25 A

Number of tests with fully charged battery pack

Approximately 60 tests

Dimensions 187 x 97 x 43 mm

Weight (without batteries) 280 g

Safety class III

Auto power off Programmable, 1 to 60 minutes

Sample material

Sample type Capillary, venous, or arterial fresh whole blood

Sample size ≥ 8 µL

Interferences As listed in the CoaguChek PT Test method sheet

Test strips

ISI Approximately 1.0

Sensitivity to heparin Insensitive to unfractionated and fractionated heparin concentrations up to 3 IU/mL

Quality control On each test strip, through the same channel as the blood passes

Stability Storage at +2 to +30°C. Test strips can be used until expiry date printed on the box and test strip vial



COAGUCHEK is a trademark of Roche.

All other product names and trademarks are the property of their respective owners.

©2016 Roche

Roche Diagnostics International Ltd CH-6343 RotkreuzSwitzerlandwww.coaguchek.com

References1. Nutescu, E.A., Wittkowsky, A.K., Burnett, A., Merli, G.J., Ansell, J.E., Garcia, D.A. (2013). Delivery of optimized inpatient anticoagulation therapy: consensus

statement from the Anticoagulation Forum. Ann Pharmacother 47, 714–724.

2. Haas, T., Fries, D., Tanaka, K.A., Asmis, L., Curry, N.S., Schöchl, H. (2015). Usefulness of standard plasma coagulation tests in the management of perioperative coagulopathic bleeding: is there any evidence? Br J Anaesth 114, 217–224.

3. Tripodi, A., Lippi, G., Plebani, M. (2016). How to report results of prothrombin and activated partial thromboplastin times. Clin Chem Lab Med 54, 215–222.

4. Tripodi, A., Caldwell, S.H., Hoffman, M., Trotter, J.F., Sanyal, A.J. (2007). Review article: the prothrombin time test as a measure of bleeding risk and prognosis in liver disease. Aliment Pharmacol Ther 26, 141–148.

5. Spahn, D.R., Bouillon, B., Cerny, V., Coats, T.J., Duranteau, J., Fernández-Mondéjar, E. et al. (2013). Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care Lond Engl 17, R76.

6. Chee, Y.L., Crawford, J.C., Watson, H.G., Greaves, M. (2008). Guidelines on the assessment of bleeding risk prior to surgery or invasive procedures. British Committee for Standards in Haematology. Br J Haematol 140, 496–504.

7. Ageno, W., Gallus, A.S., Wittkowsky, A., Crowther, M., Hylek, E.M., Palareti, G. et al. (2012). Oral anticoagulant therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e44S–88S.

8. Clinical and Laboratory Standards Institute. (2004). CLSI EP5-A2. Evaluation of precision performance of quantitative measurement methods.

The CoaguChek® Pro II system is not available in all markets. Please contact your local Roche representative to obtain the appropriate product information for your country.

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Appendix 3 references



COAGUCHEK and BECAUSE IT’S MY LIFEare trademarks of Roche. ©2014 Roche Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.coaguchek.com

References1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with

phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what

a clinician should be aware of. Semin Vasc Med 3, 243-254.3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines

for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).

5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.

6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and thrombosis, 2nd ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.

7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors. J Thromb Haemost 4, 820-827.

8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same instrument. Am J Clin Pathol 133, 550-556.

9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and thrombosis, 2nd ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.

10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin Pathol 65, 1119-1123.

11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic

Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e152S-e184S.

13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system. Thromb Res 123, 381-389.

14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulation therapy.

15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.

16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.

17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).

18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg, Germany: Workshop Report (1st edition).

19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche near patient, Mannheim, March 16, 2006 (available upon request).

20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference). 21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.

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Roche Diagnostics Ltd. Charles Avenue, Burgess Hill RH15 9RY United Kingdom

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Company registration no: 571546

© Copyright 2015. Roche Diagnostics Limited. All rights reserved.COAGUCHEK and ‘BECAUSE IT’S MY LIFE’ are registered trademarks of Roche.






















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Documents

CoaguChek Pro II Professional Monitoring System · The CoaguChek Professional Meter (CoaguChek Pro II) quantitatively determines prothrombin time (“PT”), using arterial blood,