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PT/INR Test Strips
Package Insert
REF C132-4011
MOEDL CCS-151
Mission® PT/INR Test Strips are intended for use with the Mission® PT/INR
Monitoring System to monitor blood clotting time in patients stabilized on Coumarintype (e.g. warfarin) anticoagulation therapy. The Mission® PT/INR Test Strips use
fresh capillary blood or fresh anticoagulant-free venous whole blood specimens.
The results are reported in both Prothrombin Time and INR units. For in vitro
diagnostic use only. The device is not intended to be used for screening purposes.
For self testing and professional use.
Oral anticoagulants are used to treat patients with atrial fibrillation, deep vein
thrombosis (DVT), artificial heart valves, post myocardial infarctions and other
cardiovascular disorders. These medications help to prevent blood clots, which can
cause thromboembolic events such as stroke, recurrent myocardial infarction and
pulmonary embolism. Warfarin, commonly known as Coumadin1 is frequently
prescribed and acts by inhibiting the synthesis of vitamin K-dependent clotting factors.
Oral anticoagulant drug actions tend to vary between different patients and are
subject to change over time within a patient. Warfarin is a Narrow Therapeutic
Index (NTI) drug which can be affected by factors such as drug interactions and
dietary vitamin K.2 As a result, periodic determination of INR is necessary for the
individualized management of each patient’s treatment. The INR system has
become the standard quantitative measurement internationally because it corrects
for variations among different instruments and reagents.
The Mission® PT/INR Test Strips, when used as directed with the Mission® PT/INR
Meter, will accurately and reliably measure International Normalized Ratio (INR)
values and calculate Prothrombin Time (PT) in fresh capillary blood from a finger
stick or fresh anticoagulant-free venous whole blood specimens. After inserting the
test strip in the meter, the blood specimen is applied to the Specimen Application
Area marked on the test strip. The meter detects the application of the specimen
on the strip and initiates testing. The membrane of the strip contains the reagents
necessary to begin the coagulation reaction. The time from the initial specimen
detection to the fluorescent signal response is used to calculate the reported blood
Prothrombin Time and INR value.
Each test strip contains the following reagents: 0.15% recombinant tissue factor,
0.2% calcium and buffer. Each individual test strip foil pouch contains a drying
agent.
All blood specimens and containers, capillary transfer tubes, lancets and
materials that have come in contact with blood specimens should be handled as
if capable of transmitting infectious diseases and discarded in a biohazardous
waste container. Follow your facility's biohazard control guidelines.
For in vitro use only. Do not take internally.
Check the code chip before running a PT test. Make sure to use the code chip
that is included with the box of strips in use. Insert the code chip into the code
chip slot. The code chip slot is located on the right side of the meter.
Do not add additional test specimen material after the initial specimen volume
has been applied to the test strip.
The specimen should cover the entire specimen well. A new test should be run if
an insufficient specimen is applied.
Do not apply strong repetitive pressure to the finger to get excessive blood
specimen.
It is not required that the first drop of blood be wiped away. However, the drop
must be applied within 15 seconds of the finger stick.
Do not use strips beyond the expiration date printed on the foil pouch of each
strip.
Venous whole blood collection must be done with an anticoagulant-free syringe.
Current health status may affect test results and may cause unexpected or
inaccurate results. Heath factors need to be taken into consideration when
interpreting results, and decisions of medical relevance are not to be made
without consulting a physician. Changes to treatment should only be made after
professional consultation.
Test strips may be stored at or below room temperature, 2 °C to 30 °C (36 °F to
°F).
86
If test strips are stored in the refrigerator, they must return to room temperature
by sitting in a room temperature atmosphere in their own foil packaging for at
least 15 minutes prior to use.
The test strip should be used immediately upon removal from the foil pouch.
Do not use the test strips beyond the expiration date printed on the foil pouch.
Acceptable specimens include fresh capillary (finger stick) or fresh venous arm
whole blood.
Whole blood specimens must be tested immediately after collection.
The minimum specimen volume is one hanging drop of capillary whole blood or
15L of fresh venous whole blood.
SPECIMEN COLLECTION AND PREPARATION
INTENDED USE
SUMMARY
PRINCIPLE
COMPOSITION
PRECAUTIONS
STORAGE AND HANDLING
English
MATERIALS
Test Strips
INR Mete
Latex Gloves
Capillary Transfer Tubes (optional)
The Mission® PT/INR Test Strip uses either fresh capillary or fresh venous whole
blood. Refer to the User’s Manual for blood specimen collection before use.
1. Insert the code chip contained in the Mission® PT/INR Test Strip box into the
Mission® PT/INR Meter as described in the User’s Manual.
2. Open a foil pouch; Remove the test strip.
Note: Each time before opening a test strip foil pouch, check the expiration date
on the foil pouch. Do not use if the expiration date has passed.
3. Insert the test strip into the meter. The meter will automatically turn on and beep,
if the sound is enabled. The meter will then go through a warm-up cycle.
Check to ensure the displayed code number matches the number on the strip
box. Select ‘Blood’ for a blood specimen, ‘EC Tst’ for an electronic control test,
or ‘CS Tst’ for a liquid control specimen. When the meter displays the “ADD
SPECIMEN” icon, prepare to collect the specimen.
4. Collect the blood specimen and apply the specimen to the Mission® PT/INR Test
Strip according to the instructions in the User’s Manual. The entire white circle
in the center of the target area must be filled with one drop of blood. If the
specimen well is only partially covered, repeat the test with a new strip.
5. Follow the displayed prompt to close the optics cover. The optics cover should
be closed within 20 seconds of specimen application to the test strip.
6. The PT/INR meter will perform the test for about 2 minutes and “beep” when
complete if the sound is enabled. Once complete, the meter will display the final
INR value and Prothrombin Time if INR+PT is selected. Remove and discard
the test strip. The meter will store the INR value in the memory, along with the
date and time.
7. Carefully discard any materials that came in contact with blood according to
proper biohazard control guidelines.
Note: Specimen may also be applied using a non-anticoagulated plastic capillary
transfer tube.
The Mission
Normalized Ratio (INR units). Normal Prothrombin Time results can vary from
person to person, however; an INR of 1.0 usually corresponds to a normal value.
Patients receiving anticoagulant therapy must be monitored carefully, with their
physician establishing the appropriate INR range based upon the underlying clinical
condition.
The Mission
test is completed:
The recommended therapeutic range for warfarin is most commonly between INR 2
and 4 depending upon the underlying clinical condition.3
Normal PT levels, expressed as an INR, were determined for capillary whole blood
collected from 120 healthy, warfarin-free individuals. Based upon the study
performed, the reference INR range for the Mission® PT/INR Monitoring System is
the following:
Unexpected results may include results that fall outside the therapeutic range
defined by the physician or results that fall within the therapeutic range but are
associated with unusual clinical situations (such as abnormal symptoms of bleeding
or bruising).
Possible causes for unexpected results:
A hematocrit that is higher (above 60%) or lower (below 25%) than the validated
Severe, congenital or autoimmune hypofibrinogenemia, dysfibrinogenemia,
Conditions associated with elevated fibrinogen levels, such as inflammation,
Receiving intravenous infusion therapy in the same arm from which a blood
Certain prescription or over-the-counter drugs (e.g. pain relievers) may affect the
Lupus and other conditions that lead to the production of anti-phospholipid
Changes in diet (e.g. taking nutritional supplements such as gingko biloba) and
®
PT/INR Monitoring System displays the results in the International
®
PT/INR Monitoring System will display the following values when a
Capillary Whole Blood 0.8 to 1.4
operating range of the Mission® PT/INR Monitoring System. Hematocrit levels
outside this range or severe anemia can cause inaccurate results.
hypoprothrombinemia or dysprothrombinemia, may cause patient results to
differ from a clinical reference assay system.
cancer, renal disease requiring haemodialysis and others.
specimen is taken.
action of oral anticoagulants and the INR value.
antibodies (APAs) may falsely prolong the INR level.
lifestyle may affect the action of oral anticoagulants and the INR value.
Materials Provided
Materials Required But Not Provided
0.7< INR < 7.0 Measured INR Value
Specimen Type 95 % Range
Code Chip Package Insert
Safety Lancets Control Solution
Gauze for Puncture Site Alcohol Swab
DIRECTIONS FOR USE
EXPECTED VALUES
INR Range Display
INR < 0.7 INR ↓
INR > 7.0 INR ↑
Normal Range
UNEXPECTED VALUES
4
Upon receiving abnormal results or encountering unusual clinical conditions, please
refer to a health care professional immediately and arrange for an alternative
testing method.
The Mission
to 7.0 INR. Specimens below INR 0.7 are displayed as “INR↓”. Specimens above
INR 7.0 are displayed as “INR ↑”.
Verified Clinical Range. In clinical trials, patients were tested in the INR 0.7 to 7.0
range. Performance outside of this range has not been verified.
The Mission® PT/INR Monitoring System is sensitive to deficiencies of Factors II, V,
VII and X at the following levels (3 lot averages):
Factor II Factor V Factor VII Factor X
25% 35% 42% 28%
Thromboplastin. The Mission® PT/INR Monitoring System uses recombinant
human thromboplastin. The thromboplastin reagent has an approximate average
International Sensitivity Index (ISI) of 1.0 as determined by the Sysmex CA-530
coagulation analyzer.
The Mission® PT/INR Monitoring System was compared against the Sysmex
analyzer, using human thromboplastin as a reference. The following accuracy data
were obtained.
Capillary Whole Blood (INR)
Mission® PT/INR Monitoring System vs.
Sysmex CA-530 Reference
n = 605 n = 613
Regression line: y = 1.061x - 0.044 Regression line: y = 1.049x -0.083
r = 0.924 r = 0.933
605 Capillary specimens were collected from 219 outpatients at four external sites.
Capillary whole blood specimens were assayed on the Mission® PT/INR Meter with
the Mission® PT/INR Test Strips, and venous specimens were measured on the
Sysmex CA-530 Analyzer. The results are as follows:
Site N Slope Intercept R
1 209 1.056 -0.075 0.965
2 184 1.091 -0.084 0.897
3 73 0.950 0.171 0.914
4 139 1.179 -0.274 0.882
All 605 1.061 -0.044 0.924
Capillary Data from All Sites: 605 Specimens from 219 patients
613 venous specimens were collected from 219 outpatients at four external sites.
The INR of each specimen was compared to the INR of venous plasma specimens
measured on the Sysmex CA-530 Analyzer. The results are as follows:
Site N Slope Intercept R
1 211 1.040 -0.060 0.970
2 188 1.090 -0.163 0.908
3 77 0.937 0.044 0.932
4 137 1.159 -0.286 0.903
All 613 1.049 -0.083 0.933
PERFORMANCE CHARACTERISTICS
®
PT/INR Monitoring System has a numeric PT measuring range of 0.7
Measuring Range
Sensitivity
Accura cy
enous Whole Blood (INR)
Mission® PT/INR Monitoring System
vs. Sysmex CA-530 Refere nce
Capillary Whole Blood
enous Whole Blood
Venous Data from All Sites: 613 Specimens from 219 patients
Precision studies were done using control solutions level 1 and level 2 on 3 lots of
Precision
strips. The within-day precision study included 9 tests on 3 lots at 2 levels. Day-today precision included 2 tests, 2 runs per day for 20 days.
INR
Scale
n 27 27 240 240
Mean 1.04 2.96 1.16 2.88
SD 0.05 0.11 0.01 0.03
CV 4.7% 3.8% 0.6% 1.0%
Daily control testing is good laboratory practice and may be required in your
location. Always check with the appropriate licensing or accrediting bodies to
ensure your quality control program meets the established standards.
The recommended control solutions Mission® PT/INR Control Solution Level 1 and
Level 2 should be tested when:
A new shipment of test strips is received
A new lot of test strips is opened
Improper storage or handling of the test strips is suspected
Patient PT results are unusually low or high
Control tests are performed in a very similar way to blood tests, using the
commercially available liquid controls instead of blood. The User’s Manual and
Control Solution Insert should be read before using the controls. The system is
working properly if the control value displayed by the meter is within the acceptable
range for the control solution tested. The acceptable control range can be found on
the pouch label. If the value is not acceptable, please contact your local distributor
for assistance.
The following have no significant effect on test results:
Hematocrit ranges between 25% and 60%
Hemolyzed specimens with up to 500 mg/dL of hemoglobin in plasma
Bilirubin concentrations up to 20 mg/dL
Triglyceride concentrations up to 3000 mg/dL
Heparin and Low Molecular Weight Heparin up to 2 U/mL
Fondaparinux at the concentration ≥ 0.1 mg/dL or therapeutic level could
falsely increase the INR level compared with laboratory reference methods.
The Mission® PT/INR Monitoring System was designed to provide a quantitative
measurement of Prothrombin Time for patients on warfarin therapy. S elf -t es tin g
patients should be stabilized on warfarin therapy for at least 6 weeks.
The Mission® PT/INR Monitoring System should not be used on individuals with
severe coagulopathies such as disseminated intravascular coagulation (DIC)
and other conditions with rapid changes in coagulation status (e.g. severe
sepsis, septic shock, and hypotensive shock).
A full hanging drop of blood should always be applied onto a test strip. Never
apply a second drop of blood onto the same test strip. Always use a new test
strip when performing a new test.
Low specimen volume (typically under 10L) will cause a specific error
message.
1. Coumadin is a registered trademark of the Bristol-Myers Squibb Pharma Company.
2. Coumadin
3. Cunningham, Mark et. al. "The Reliability of Manufacturer-determined Instrumentspecific International Sensitivity Index Value for Calculating the International Normalized
Ratio." Am. Jrnl. Clin. Pathol. July 1994. Volume 102, Number 1:128-133.
4. Sanfelippo, MJ et. al. “Falsely elevated INRs in warfarin-treated patients with the lupus
anticoagulant.” WMJ. 2000 Jun; 99(3):62-4, 43.
REF
5850 Oberlin Drive, #340
San Diego, CA 92121, USA
Within-Da
3 Strip Lots
Level 1 Level 2 Level 1 Level 2
Official Package Insert. Rev. October 2011.
Consult instructions for use
In vitro diagnostic medical
device
Catalogue number
Temperature limit
Contains sufficient for <n>
tests
Code Number
Authorized representative in the European Community
Laboratories, Inc.
QUALITY CONTROL
LIMITATIONS
BIBLIOGRAPHY
Index of Symbols
MODEL Model number
0123
Day-To-Day (Between Day)
3 Strip Lots
Use by
Lot Number
Manufacturer
Do not reuse
Control Range
MDSS GmbH
Schiffgraben 41
r, Germany
Number: 1151121003
Effective date: 2021-05-27
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