Alere INRatio ® 2 PT/INR Professional Test Strip Package Insert

Alere INRatio ® 2 PT/INR Professional Test Strip Package Insert
Storage and Handling
ENSRC26340enA
© 2013 Alere. All rights reserved.
PN 26340en Rev. A 2013/03
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121 USA
1.877.441.7440
www.alere.com
MDSS GmbH
Schiffgraben 41
30175 Hannover,
Germany
The Alere Logo, Alere and INRatio are trademarks of the Alere group
of companies. All trademarks referenced are trademarks of their
respective owners.
Store strips as packaged in their foil pouch until ready to use and
until the expiration date printed on the package:
• Room temperature: 50 ºF to 90 ºF (10 ºC to 32 ºC).
• Refrigerated: 35 ºF to 50°F (2°C to 10°C). Allow foil pouch to
come to room temperature for five (5) minutes before opening the
pouch. Do not freeze.
NOTE: Use the test strip within ten (10) minutes of opening the
foil pouch.
Testing Flow Overview
Gather Materials
Turn On Monitor /
Insert Test Strip
Alere INRatio®2 PT/INR Professional Test Strips
Alere INRatio®2 PT/INR Professional Test Strips for use with
the Alere INRatio®2 Professional Testing Kit
Please read all of the information in this package insert and in
the Alere INRatio®2 PT/INR Professional Testing Kit User Guide
for complete instructions before performing the test. If you have
questions, call Alere™ Technical Services for assistance. (See the
Assistance section).
Unless otherwise specified, the term “monitor” is used to describe
the Alere INRatio®2 PT/INR Professional Testing Kit. Unless
otherwise specified, the term “Monitoring System” refers to the
use of this monitor in conjunction with the Alere INRatio®2 PT/INR
Professional Test Strip.
Intended Use
Alere INRatio®2 PT/INR Professional Monitoring System: The Alere
INRatio®2 PT/INR Professional Monitoring System, consisting of
the Alere INRatio®2 PT/INR Monitor and the Alere INRatio®2 PT/INR
Professional Test Strip, is used for quantitative determination of
International Normalized Ratio (INR) in fresh capillary whole blood
to monitor the effect of warfarin on clotting time by health care
professionals. The Alere INRatio®2 PT/INR Professional Monitoring
System is intended for use outside of the body (in vitro diagnostic
use). The Alere INRatio®2 PT/INR Professional Monitoring System is
not intended to be used for screening purposes.
Limitations: The Alere INRatio®2 PT/INR Professional Monitoring
System is not intended for use in patients who are transitioning from
heparin treatment to warfarin therapy.
Materials Provided: Test Strips
Enter or Verify STRIP
CODE When Prompted
Apply Sample
When Prompted
Result Displayed
Dispose of Strip and
Biohazardous Materials
Prepare to Test
Please read all of the information in this package insert and the
monitor user guide for complete instructions before performing a
test. Symbols used in these instructions are defined in the monitor
user guide.
Gather the items needed (See the Materials Provided and Materials
Required But Not Provided sections, above).
Perform a Test
Follow proper infection control guidelines for handling all
blood samples and anything that comes in contact with
blood.
NOTE: The test strip must be at room temperature before
opening the foil pouch.
1.Turn the monitor on:
a. Go to step 2 to turn the monitor on by inserting a test strip.
b.OR press the OK button. Wait for the Insert Strip symbol ,
then go to Step 2.
2.Open a test strip foil pouch and remove the test strip. Insert the
strip into the monitor with “INRatio®” facing upright at the bottom
of the test strip.
NOTE: Use the strip within 10 minutes of opening the foil pouch.
3.Check that the Strip Code on the monitor display matches the
one on the test strip pouch. Press OK if it does. If not, see the
monitor user guide for detailed instructions on how to change the
Strip Code.
# 99008must
and 99008G2
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CAUTION:
This
must be done. Running a test
with an incorrect strip code may cause inaccurate
Materials Required But Not Provided
results.
• Alere INRatio®2 PT/INR Professional Testing Kit (monitor):
4. Wait while the monitor warms up.
# 55128 and 55128a
5.The monitor will beep and the Apply Sample symbol will appear
• Alcohol and gauze pads
on the monitor display. The green sample target light will also
Puncture-proof waste container for biohazard and
appear through the test strip sample well.
sharps waste
6.Collect a finger stick (capillary) blood sample, as described below.
• Gloves (required for a finger stick)
HOW TO DO A FINGER STICK:
Introduction
NOTE: Refer to instructions provided with the finger stick lancet
Prothrombin Time (PT) is a test of the blood’s ability to clot. In certain
device, and the directions in the monitor user guide.
medical conditions (i.e. atrial fibrillation or mechanical heart valves)
a.Prepare the lancet device according to the manufacturer’s
blood clots are more likely to form, and there is an increased risk
instructions.
of stroke. Oral anticoagulant drugs (vitamin K antagonists), such as
1
warfarin, are used to prevent such clots.
b.Wash hands in soap and warm water, OR, clean finger tip with
an alcohol pad. Dry thoroughly.
Patients taking warfarin must have their level of anticoagulation
NOTE: A large hanging blood drop is required to perform the test.
tested often with the PT test. The warfarin dose is adjusted based
Follow these suggestions to increase blood flow to the finger tip:
on the PT test results compared to a recommended therapeutic
range. For monitoring warfarin, the PT is reported as International
• Warm the hand: Wash in warm water, rub hands together, or
Normalized Ratio (INR), using the ISI (International Sensitivity Index
use a hand warmer.
of the thromboplastin reagent used). The INR takes into account
•
Let the arm hang down, hand below waist, fingers pointing
differences between PT methods:
to the floor.
ISI
Patient PT
• Massage the arm from elbow to wrist to finger tip.
INR =
Mean Normal PT of Population
c.Make sure the monitor displays the Apply
Sample symbol . Place the tip of lancet
Each lot of test strips is calibrated to a reference lot of human
device against the side of a middle finger that
recombinant thromboplastin traceable to the WHO International
faces the floor. Press the trigger button.
Reference Preparations.2 The ISI (International Sensitivity Index) for
each lot of test strips has been established as 1.
Test Principle
The Alere INRatio®2 PT/INR Professional Monitoring System,
which includes a monitor and test strip, measures a version of the
one-stage PT test (the time needed for blood to clot). After a blood
drop is applied to the test strip, it is drawn into the test area and
mixes with reagents that start the clotting process. As the blood
clots, the monitor detects changes in electrical current passing
through the sample. The monitor calculates the INR result from these
changes, and reports the result on the display.
Precautions and Warnings
1. For in vitro diagnostic use. Do not eat.
Follow proper infection control guidelines for handling all
blood samples and related items. All parts of the Monitoring
System are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed
cleaning and disinfection. Refer to the monitor user guide for
proper cleaning and disinfection procedures.
2. Use only fresh capillary (finger stick) whole blood.
3. Lancets are for single patient use only. Do not share them
with anyone including family members. Do not use on multiple
patients! Dispose safely after use.
4. Do not use strong pressure. Do not “milk” the finger to collect
the blood drop.
5. Never add more blood after testing has begun.
CAUTION: Gently squeeze the finger tip to promote
blood flow. DO NOT use strong pressure. Do not “milk”
the finger to collect the blood drop or you may get
inaccurate results.
NOTE: Apply the first hanging drop to the sample well on the
test strip.
d.Immediately apply the blood to the test strip by
lightly touching the bottom of the blood drop to
the oval sample well. Hold the finger over the
test strip sample well until the monitor displays
the Countdown display:
You can then pull the finger away from the test
strip.
NOTE: Do not smear the blood onto the strip.
NOTE: Do not add more blood to the test strip once testing has
begun. Do not touch or remove the test strip during TESTING.
7. Press a piece of gauze over the puncture site until the bleeding stops.
8. Wait while the monitor performs the test and reads the results.
9.When the test is complete, the monitor will beep and the INR
result will appear on the display.
If an error message appears, see the monitor user guide
Troubleshooting section for proper action.
10. Remove the test strip.
Follow proper infection control guidelines for handling all blood
samples and anything that comes in contact with blood.
Users should adhere to standard precautions when handling
or using this device. All parts of the Monitoring System
should be considered potentially infectious and are capable
of transmitting blood-borne pathogens between patients
and healthcare professionals. For more information, refer to
“Guideline for Isolation Precautions: Preventing Transmission
of Infectious Agents in Healthcare Settings 2007.”
11.Wash hands thoroughly with soap and water to prevent the
transmission of potential blood borne pathogens.
Dispose of all items that have come in contact with blood.
Be sure to follow proper infection control guidelines. Refer to
the monitor user guide for proper cleaning and disinfection
instructions, or if monitor screen becomes cloudy.
Results
Results are reported in INR units as typically seen in laboratory
reference methods. Refer to the monitor user guide for details.
Normal and therapeutic INR levels vary from person to person.
For PT testing, variations in the type of reagent (thromboplastin)
and/or system sensitivity may cause some variation in results. It is
recommended that the same system be used to monitor a patient
over time.
Reference Range: 0.8-1.3 INR
The reference range for the Monitoring System was determined by
testing normal (not anticoagulated) subjects. (360 INR results were
pooled from 120 subjects across three strip lots.)
Therapeutic Range:
A health care professional must determine the target therapeutic
range for each patient. This is based on anticoagulation therapy and
each patient’s response to treatment. INR results from the Monitoring
System must be assessed by the health care provider against the
patient’s specific target therapeutic range.
Unexpected Results:
An unexpected result may include any result that falls outside the
therapeutic range, or a result that falls inside that range but is not
consistent with the clinical symptoms. See below for more details.
What Causes Unexpected Results:
The following may cause unexpected results, by affecting the action
of oral anticoagulants and the INR value:
• Changes in diet, lifestyle, or taking nutritional supplements such
as ginkgo biloba can affect the action of oral anticoagulants.
• Certain over-the-counter medicines and prescription drugs (i.e.
antibiotics) can affect the action of oral anticoagulants. Starting,
stopping, or changing the dose of such medicines can affect the
INR.
• Liver disease, congestive heart failure, thyroid dysfunction,
and other diseases or conditions can affect the action of oral
anticoagulants and the INR.
• Please see the LIMITATIONS section to understand other causes
of unexpected results.
What to do when you get an unexpected result:
If the result is outside the therapeutic range, follow health care
provider’s instructions for re-testing, and guidance for adjusting
warfarin dose if required.
• If, after re-testing, the result is still outside the therapeutic
range, consider the above causes. The health care provider
should be aware of the conditions that cause unexpected results
and determine the need for additional patient medical history,
checking the patient’s hematocrit or other limitations, or testing
by an alternative method.
• If the result falls within the therapeutic range, but there is reason
to believe the INR could be significantly different (e.g., symptoms
such as bleeding or bruising when an INR value is low), testing
by an alternative method should be immediately arranged.
Quality Control (QC)
QC is important to ensure the proper test technique, integrity of
the test strip and performance of the whole system. Each test strip
includes two control channels that test a low and a high PT control
each time a blood sample is tested. INR results are only displayed
if both QC results are in a pre-defined range. Use of external liquid
quality controls is not needed with the Monitoring System. Refer to
the monitor user guide for additional information about QC.
Limitations
1. Testing in studies has been limited to people 18 years of age
and older.
2. If insufficient blood is utilized for testing an error message will be
displayed. Please refer to the user manual. In laboratory testing,
a minimum of 9.5 μL of whole blood was shown to be required
to fill the test strip and provide a test result.
3. If performing a new test, use a new lancet to obtain a fresh
blood drop from a different finger and use a new test strip.
4. Accuracy is validated for hematocrit values between 25% and
53%. A hematocrit outside this range may cause an inaccurate
result or error message.
5. Accuracy is validated for operating temperature 50 ºF to 90 ºF
(10 ºC to 32 ºC) and relative humidity 15%-90%. Testing at
temperature and relative humidity outside this range may cause
inaccurate result or error message.
6. Lupus or antiphospholipid antibody syndrome (APS) may cause
a false high INR value in many systems, including the Monitoring
System. Testing with an antiphospholipid antibody-insensitive
laboratory method is recommended for these patients.
7. In vitro studies showed the following substances do not interfere
with test results, up to the plasma concentrations shown:
Substance
Bilirubin
Triglycerides (lipemia)
Hemoglobin (hemolysis)
Up to this concentration
up to 30 mg/dL
up to 1500 mg/dL
up to 1000 mg/dL
8. In vitro studies showed that the drugs listed below do not
interfere with test results when spiked into whole blood, up to
the plasma concentrations shown:
Drug
Fondaparinux
Acetylsalicylic acid
Clopidogrel
Atorvastatin
Unfractionated Heparin
Low Molecular Weight Heparin
Up to this concentration
up to 5 mg/L
up to 4 mmol/L
up to 20 mg/dL
up to 600 μg/L
up to 2 Units/mL
up to 3 Units/mL
Performance Characteristics
Reagents
• Reagent channel: a protein (recombinant human thromboplastin)
and additives.
• Control channels: human, plasma-extracted clotting proteins
and additives to yield preset clotting range times for a low and
high control.
Measuring Range: 0.7 to 7.5 INR
For results below or above this range the monitor will display “INR< 0.7”
or “INR >7.5” (INRatio®2 also flashes a CAUTION symbol
).
Factor Sensitivity: The Monitoring System is sensitive to Factors
II, V, VII, and X at the following levels (% of normal factor level;
in vitro testing):
Factor II: <56%
Factor V: <62%
Factor VII: <78%
Factor X: <74%
Health Care Professionals (HCP)
Accuracy: A multi-center study was conducted at four (4) external
clinical sites with blood collected from subjects on oral anticoagulation
therapy and normal subjects not on oral anticoagulation therapy. The
INR was measured on fingerstick capillary whole blood on an Alere
INRatio®2 PT/INR Monitoring System from each subject and was
compared to the INR of a venous plasma sample measured on the
Sysmex® CA-560 System using Dade Innovin® reagent (Reference
System) collected at the same time from the same subjects. Results
are shown in figure 1.
Figure 1 Professional: Comparison of fingerstick (capillary) whole
blood INR results on Alere INRatio®2 PT/INR Monitoring System to
plasma (venous) INR results on Sysmex®/Dade Innovin® system. Data
are from all four (4) sites combined.
8
Regression Statistics
(Deming):
7
288 subjects
4 clinical sites
y = 1.05x - 0.05
6
5
4
95% confidence interval of
slope: 0.97 to 1.12.
95% confidence interval of
intercept: (-0.22 to 0.12)
Pearson correlation
coefficient (r):= 0.91
3
2
1
0
0
1
2
3
4
5
6
7
8
Reference System INR (plasma)
Data
Identity Line
Regression Line
Precision: Precision of the system for professional users was
assessed in the clinical trial described above. Professional users
tested fingerstick (capillary) whole blood samples. Precision was
assessed by conducting duplicate testing of samples from normal
and therapeutic subjects (N = number of duplicate pairs) within
specified INR ranges. Precision is expressed as a percent coefficient
of variation (%CV) and standard deviation (SD) around the Mean
INR value for the duplicate pairs within the indicated INR ranges
(Table 1). Results are calculated both with and without outlier
removal using the duplicate range limit method recommended by
ISO.3 These are representative data; results in individual laboratories
and from other test strip lots vary from these data.
Table 1: Health Care Professionals Precision
INR Interval
INR < 2.0
(Normal Subjects)
INR 2.0 to 4.5
Precision
All Pairs Included
N
SD
CV
Precision
Outliers Removed
N
SD
CV
24
0.119 11.07%
22
0.088
8.16%
192
0.282 9.56%
181 0.180
6.16%
Home/Patient Self Test (PST)
Study Demographics:
Subjects in the home PST user study ranged from 28 to 88 years of
age (median age 66; 29% of subjects were above 75 years of age)
and 69% were male. Representative races included White, AfricanAmerican, Asian, Hispanic, Pacific Islander.
Summary of PST Demographics:
N
106*
Median Age
66
Age Range
28 to 88
Age >75
31 (29.2%)
Female
33 (31.1%)
Male
73 (68.9%)
ASIAN
2 (1.9%)
BLACK
11 (10.4%)
HISPANIC
2 (1.9%)
ISLANDER
1 (0.9%)
WHITE
90 (84.9%)
*Only 105 out of 106 patients had evaluable plasma samples for the
method comparison.
Clinical conditions requiring warfarin therapy included atrial
fibrillation, deep vein thrombosis, mechanical heart valve, pulmonary
embolism, ischemic stroke, myocardial infarction, and others.
Reason for OAT
Percent*
Atrial Fibrillation
62.3
Ischemic Stroke
3.8
Mechanical Heart Valve
11.3
Myocardial Infarction
0.9
Deep Venous Thrombosis
16.0
Pulmonary Embolism
5.7
Other
12.3
*Percent is relative to 106 patients; some patients list more than
one reason, so total is greater than 100%.
Accuracy: A multi-center study (4 external clinical sites) was
conducted in which subjects on anticoagulant therapy were trained
using the user guide and test strip package insert to conduct
fingerstick INR testing with the Alere INRatio®2 PT/INR Monitoring
System. Subjects tested weekly, over 8 weeks, and the following
data were collected at the end of the 8 week period. Fingerstick
(capillary) INR results obtained by the trained PST user were
compared to corresponding plasma (venous) INR results obtained
at a central laboratory (Sysmex CA-560 System using Dade Innovin®
(Reference System)). Results are shown in Figure 2.
Figure 2: Home / Patient Self Test (PST): Comparison of fingerstick
(capillary) whole blood INR results on the Alere INRatio®2 PT/INR
Monitoring System to plasma (venous) INR results on Sysmex®/Dade
Innovin®. Data are from all four (4) sites combined.
8
Regression Statistics
(Deming):
7
105 subjects,
4 clinical sites, Last clinic visit
y = 1.07x - 0.19
6
Patient Self Test INR
99008, 99008G2
6. Test with the monitor on a level surface that is free of vibrations.
Do not move or touch the monitor during testing.
Current health status may affect test results and cause unexpected
or inaccurate results. It is important to take certain health factors
into account when reading test results and setting a course of
action. Failure to do so may lead to an incorrect interpretation of the
INR result. See the Results and Limitations sections below for more
on this subject.
Capillary INR
INRatio®2 PT/INR
Professional Test Strips
Package Insert
5
4
95% confidence interval of
slope: (0.92, 1.23),
95% confidence interval of
intercept: (-0.55, 0.18)
Pearson correlation
coefficient, (r) = 0.93.
3
2
1
0
0
1
2
3
4
5
6
7
8
Reference System INR (plasma)
Data
Identity Line
Regression Line
Results showed that trained PST users are able to operate the
Alere INRatio®2 PT/INR Monitoring System and obtain accurate INR
results using fingerstick (capillary) blood.
Precision: Precision of the system for PST was assessed in the
clinical trials described above. Home PST users tested fingerstick
(capillary) whole blood. Precision was assessed by conducting
duplicate testing of samples (N = number of duplicate pairs)
within specified INR ranges. Precision is expressed as a percent
coefficient of variation (%CV) and standard deviation (SD) around
the Mean INR value for the duplicate pairs within the indicated INR
ranges (Table 2). Results are calculated both with and without outlier
removal using the duplicate range limit method recommended
by ISO.3 These are representative data; results in individual
laboratories, from individual patients, and from other test strip lots
vary from these data.
Table 2: Home / Patient Self Test Precision
Precision
All Pairs Included
Precision
Outliers Removed
INR Interval
N
N
SD
CV
INR 2.0 to 4.5
70
66
0.153
5.68%
SD
CV
0.205 7.65%
References
1. Ansell, J., et. al., Pharmacology and management of the Vitamin
K Antagonists.CHEST 2008; Vol. 133, Number 6 (SUPPL):
Antithrombotic and 1. Thrombolytic Therapy: American College
of Chest Physicians Evidence-Based Clinical Practice Guidelines
(8th Edition): 160S – 198S
2. WHO Expert Committee on Biological Standardization. 48th
report. World Health Organ Tech Rep Ser: 1999; 889:64-93.
3. ISO/DIS 17593 Clinical laboratory testing and in vitro
diagnostic test systems – In vitro monitoring systems for
anticoagulant therapy self-testing. International Organization for
Standardization (2007:E).
4. FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010) http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.html
5. CDC Clinical Reminder: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) http://www.cdc.gov/injectionsafety/FingerstickDevicesBGM.html
Glossary Of Symbols
• INR
PRO
International
Normalized Ratio
For
Professional
Use
Manufacturer
In Vitro
Diagnostic
medical device
Consult instructions
for use
Do not
reuse
Catalog Number
Temperature
limitation
Strip Code
Contains sufficient
for <n> tests
Batch Code /
Lot Number
Use By
(date)
Strip
Code
Authorized
Representative
CE Mark
QC
Biological Risk:
Disposable items
pose biological risks.
Internal
Quality
Control
Assistance or Additional Information
Alere™ Technical Services
Contact Alere™ Technical Services if you have any questions
regarding the use of your Alere™ product. You may also contact us
at www.alere.com.
Region
Phone
E Mail Address
Europe &
Middle East
+44.161.483.9032
EMEproductsupport@alere.com
Asia Pacific
+61.7.3363.7711
APproductsupport@alere.com
Africa, Russia,
+972.8.9429.683
& CIS
ARCISproductsupport@alere.com
Latin America
+ 57 2 6618797
LAproductsupport@alere.com
Canada
+ 1.613.271.1144
CANproductsupport@alere.com
US
+1.877.866.5313
INRatio.Support@alere.com
Alere™ Customer Service
Contact the following Alere™ Service Care Center or your local
distributor for order and billing assistance. You may also contact us
at www.alere.com.
Phone
E Mail Address
+ 1.877.441.7440
clientservices@alere.com
Return Policy
If there is a problem with the Alere INRatio®2 PT/INR Test Strips,
you may be asked to return them. Before returning test strips please
obtain a return authorization number from your local distributor.
This return authorization number must be on the shipping carton
for return.
Limited Warranty. FOR THE APPLICABLE WARRANTY PERIOD,
ALERE WARRANTS THAT EACH PRODUCT SHALL BE (I)
OF GOOD QUALITY AND FREE OF MATERIAL DEFECTS,
(II) FUNCTION IN ACCORDANCE WITH THE MATERIAL
SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL,
AND (III) APPROVED BY THE PROPER GOVERNMENTAL
AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR
INTENDED USE (the “LIMITED WARRANTY”). IF THE PRODUCT
FAILS TO MEET THE REQUIREMENTS OF THE LIMITED
WARRANTY, THEN AS CUSTOMER’S SOLE REMEDY, ALERE
SHALL EITHER REPAIR OR REPLACE, AT ALERE'S DISCRETION,
THE PRODUCT. EXCEPT FOR THE LIMITED WARRANTY
STATED IN THIS SECTION, ALERE DISCLAIMS ANY AND ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT
LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT
REGARDING THE PRODUCT. ALERE'S MAXIMUM LIABILITY
WITH ANY CUSTOMER CLAIM SHALL NOT EXCEED THE NET
PRODUCT PRICE PAID BY CUSTOMER. NEITHER PARTY SHALL
BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INCIDENTAL
OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT
LIMITATION, LOSS OF BUSINESS, PROFITS, DATA OR REVENUE,
EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE
KINDS OF DAMAGES MIGHT RESULT.
The Limited Warranty above shall not apply if the Customer has
subjected the Product to physical abuse, misuse, abnormal use, use
inconsistent with the Product Manual or Insert, fraud, tampering,
unusual physical stress, negligence or accidents. Any warranty claim
by Customer pursuant to the Limited Warranty shall be made in
writing within the applicable Limited Warranty period.
Protected by U.S. Patents 6,046,051; 6,060,323; 6,066,504;
6,338,821; 6,673,622.
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