Universal Biosensors Xprecia Prime PT or INR Test Strips Instructions

Xprecia Prime™
PT/INR Test Strips

Xprecia Prime™ PT/INR Test Strips are for use with the Xprecia Prime™ Coagulation Analyzer. Other test strips will not work with the analyzer.

Intended use

The Xprecia Prime™ System is for determination of the International Normalized Ratio (INR, related to prothrombin time) for the monitoring of oral anticoagulation therapy with warfarin (a vitamin K antagonist) in fresh capillary whole blood. It is an in vitro diagnostic device intended for multi- patient use in professional healthcare settings, including point-of care settings.

Summary and explanation

A Prothrombin Time test was first reported in 1935 ¹.
The INR was first introduced in the 1980s as a way to standardize the prothrombin time between centers using different reagents and was adopted by the World Health Organization not long after. ², ³
It has become one of the most useful tests for evaluating the extrinsic coagulation pathway. The test provides a method for monitoring anticoagulant drug therapy, (e.g. warfarin). Warfarin is a vitamin K antagonist that reduces the activity of Factors II (prothrombin), VII, IX, and X.⁴

Principles of the procedure
Warfarin is a prescribed anticoagulation medication, commonly referred to as a blood thinner. It prevents blood clots from forming in blood or blood vessels. The physician needs to monitor warfarin activity to ensure that the dosage is correct and the patient stays within a specific therapeutic range. Monitoring is done by measuring the time it takes for blood to clot and reporting it as a standardized result (INR). To perform a test, a test strip is inserted into the strip port on the analyzer. A sample of blood is then applied to the target area of the strip and drawn into the strip’s reaction chamber by capillary action. The analyzer stops the test when the blood has clotted and an INR result is displayed.

Reagents
Xprecia Prime™ PT/INR Test Strips are packaged invites with 25 strips in each. Each test strip contains the reagent Dade® Innovin®, a preparation of purified recombinant human tissue factor combined with synthetic phospholipids, calcium, and stabilizers.

Warnings and cautions

• Always follow the instructions, safety procedures, and precautions listed here and throughout the Xprecia Prime™ Coagulation Analyzer User Guide, and those adopted by your healthcare facility.

• Parts of the Xprecia Prime™ Coagulation Analyzer could become contaminated during patient testing and thus capable of transmitting blood-borne pathogens between patients and healthcare professionals. For more information, consult:
  – “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010), https://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html
  – “Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition” Clinical and Laboratory Standards Institute (CLSI) M29-A4.
  – Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)”,
  https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
  – “Biosafety in Microbiological and Biomedical Laboratories (BMBL)”, found at https://www.cdc.gov/labs/BMBL.html

• The device must be disinfected between patients (as described in the Xprecia Prime™ Coagulation Analyzer User Guide).

• A new pair of clean gloves should be worn by the user before testing each patient.

• Only use auto-disabling, single-use lancing devices.

• Always store test strips in their original vial and with the cap firmly closed.

• After removing a test strip from the vial, use the strip within 10 minutes.

• Apply capillary blood to the test strip within 2 minutes of being prompted to do so by an “apply sample” message on the analyzer’s screen.

• The capillary blood sample must be applied to the test strip within 30 seconds of sample collection.

• A test strip must be used only once.

• Do not touch or move the test strip after you apply the blood sample or while the test is in progress.

• Do not use a strip that is past its expiration or discard date.

• Do not touch a test strip with wet hands or wet gloves.

• Do not use a strip that has been dropped or which may have been contaminated.

• Do not use a strip if it appears damaged in any way.

• Do not use venous whole blood.

• Never add more blood to the test strip after the test has begun.

• After use, dispose of the test strip as biohazardous waste.

Storage and stability
Always store Xprecia Prime™ PT-INR Test Strips as follows (do not refrigerate):

| Storage| Stability
---|---|---
| °C  °F
Unopened| 2 – 30 36 – 86
0 – 75 % RH| See expiry date
on packaging
Opened| 2 – 30 36 – 86
0 – 75 % RH| 3 months

Liquid Quality control
For liquid quality control information, see the instructions for use that came with your Xprecia™Systems PT Controls Kit, with precision data for the precip Prime™ system as follows:

Statistic| PT Control
1| PT Control
2
---|---|---
Mean (INR)| 1.2| 3
Repeatability (S.D. INR)| 0.02| 0.04
Repeatability (% CV)| 1.3| 1.5
Within Laboratory (S.D. INR)| 0.02| 0.06
Within Laboratory (% CV)| 1.4| 1.9

Materials
Provided

• Xprecia Prime™ PT/INR Test Strips
  Not provided

• Xprecia Prime™ Coagulation Analyzer

• Single-use, auto-disabling lancing device (21–23 gauge, 1.8–2.0 mm depth)

• Cotton ball or tissue

• Alcohol wipe

• A cleaning and disinfecting wipe is recommended by
  Universal Biosensors (see your Xprecia Prime™
  Coagulation Analyzer User Guide)

• A lint-free tissue or cloth for drying the analyzer after cleaning

Specimen preparation and collection

Preparing the patient

1. Put on a pair of clean protective gloves.

2. Prepare the patient according to your facility’s standard procedures. For example, clean the finger with an alcohol wipe.

3. Dry the patient’s fingertip in preparation for taking the sample.

4. Prepare a new lancet according to the manufacturer’s instructions.
   Collecting a sample
   Before taking the sample, make sure that the strip and analyzer are ready.
   **** • Always close the strip vial immediately after removing a strip.
   • The capillary blood sample must be tested within 30 seconds of collection.
   • Use only capillary blood, not venous blood

5. Take a strip from a vial (firmly closing the vial immediately afterward). If this is the first time the vial has been opened, write the discard date on the vial’s label as the date in 3 months’ time.

6. Power up the analyzer and start a test. Follow the on-screen instructions. When prompted by the analyzer, insert the strip into the strip port with the printed side facing upward and the arrows pointing toward the analyzer.

7. Wait for the analyzer to warm up and for the apply sample screen to appear.

8. Place the lancet firmly against the finger and press the lancet trigger.

9. Gently squeeze from the base of the finger to form a drop of blood. Wipe off the first drop of blood with a tissue and gently squeeze out a second, hanging drop of blood. If the blood smears, wipe it off and try again. The drop should be about the same size as the strip’s target area (the white, semi-circular notch at the base of the strip). A minimum of 8 μL is required.
   Performing the test

10. With the apply sample screen visible, hold the analyzer so that it is level and then transfer a drop of blood from the patient’s finger to the white, semicircular notch at the base of the strip (the target area). You must finger-stick the patient and transfer blood to the strip within 4 minutes of the apply sample screen appearing. Fill the entire target area with blood without overfilling it. A tone will sound when blood is detected on the strip and the analysis begins.

11. When the analysis is finished and the test is complete, the INR value is displayed.

12. Hold the analyzer over a biohazard container so that the strip points towards the opening of the container, then press the strip eject button.

13. Discard the lancet in a biohazard container.

14. Clean and disinfect the entire exterior surface of the analyzer and the inside of the protective cap.
    Using cleaning fluids other than those recommended in the Xprecia Prime™ Coagulation Analyzer User Guide could damage the analyzer.

15.  Remove your gloves and thoroughly wash and dry your hands before performing another patient test.

Results
The Xprecia Prime™ Coagulation Analyzer displays the result as an INR. Depending on the reason for anticoagulation therapy and how each patient responds to treatment, the physician must select the most appropriate therapeutic INR range for his or her patient population or individual patients. 5 Differences in reagents, instruments, and pre-analytical variables can affect INR results. This should be considered when comparing different PT test methods 3. Xprecia Prime™ also displays PT results in seconds. The reported time is derived from the INR result and the equation below. The calculation is performed with an ISI of 1.0 and a typical Mean Normal Plasma Prothrombin Time of 12.0 seconds.

Limitations

The Xprecia Prime™ System is only for measuring INR in patients on Vitamin K Antagonist oral anticoagulation therapy (e.g., Warfarin, Coumadin etc). It should not be used to measure INR in patients on other anticoagulation therapies. Hematocrit levels of between 25 and 55% do not significantly affect test results. In vitro testing has shown the Xprecia Prime™ System’s results are not affected by the following drugs up to the associated concentration:
4-Aminoantipyrine 37.5 mg/L, 4-MethylaminoantipyrineHCl 25 mg/L, Acetaminophen (Paracetamol) 20 mg/dL,
Apixaban 0.02 mg/L, Ascorbic Acid 4.5 mg/dL, Atorvastatin 96 mg/L, Bilirubin conjugated 29 mg/ dl, Bilirubin unconjugated 20mg/dl, Calcium Dobesilate 9.4mg/L, Dabigatran 0.01 mg/L, Daptomycin 0.54 g/L, Dexamethasone 0.6 mg/L, Edoxaban 15 µg/L, Enanthate(testosterone) 480 mg/L, Ethinyl estradiol 0.288 mg/L, Fondaparinux 5 mg/L, Hemolysis as HbAo 200 mg/dL, Ibuprofen 2.88 g/L, Levonorgestrel 1.8 mg/L, Lipemia (triglyceride) 3270 mg/dL, Low Molecular WeightHeparins (Clexane and Fragmin) 3 IU/mL, NovalginInjection 375 mg/L, Oritavancin 10 mg/L, Prasugrel(efficient) 72 mg/L, Prednisolone 3 mg/L, ProtamineSulfate 2.5 mg/L, Rivaroxaban 0.02 mg/L, Salicylic acid(Aspirin) 69.5 mg/dL, Unfractionated Heparin 3000 U/L, Uric Acid 24 mg/dL.
Note: Patients with high results (INR > 8.0) are outside the reporting range. Such results should be confirmed using an alternative test method (approved by the patient’s physician).

Expected values
When capillary samples from normal, healthy, warfarin-free individuals were analyzed using the Xprecia Prime™ System, 95% of the INRs ranged from 0.9 to 1.1. Each lot of Xprecia Prime™ PT/INR Test Strips is calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation.
Unexpected results
If an unexpected result is reported, or if you are concerned that a result does not match the patient’s symptoms or history, the test should be repeated with a fresh fingerstick. If a similar result is obtained, the patient should be tested by other means (e.g., laboratory PT/INR). Differences in reagents, instruments and pre-analytical variables can affect INR results. This should be considered when comparing different PT test methods.
Inconsistent results could indicate poor test strip storage, interference by certain drugs, changes in the patient’s diet, or analyzer malfunction. An LQC test using the Xprecia™ Systems PT Controls Kit can be performed to verify that the system is working properly. If the LQC test fails, consult the troubleshooting section in the Xprecia Prime™ Coagulation Analyzer User Guide.

Performance characteristics

Reporting range
0.8–8.0 INR. Results outside this range will not be reported.
Factor sensitivity
Single-factor depleted plasma was combined with a normal plasma donor to produce a series of diluted plasma samples. These plasma samples were combined with red blood cells and these whole blood samples were tested across 3 lots of test strips on Xprecia Prime. The Xprecia Prime™ System is sensitive to deficiencies of Factors II, V, VII, and X.

Accuracy
The Xprecia Prime™ System was compared against the Sysmex CS-2500 at 4 point- of-care sites using 7 different strip lots. The accuracy data obtained from all sites was: N = 215, Slope = 0.93, Intercept = 0.13, Coefficient of Determination = 0.978.

Repeatability
Capillary whole blood precision was determined over 6 weeks at one point-of- care site using 3 different lots of test strips. The tests were run by typical point-of-care operators.

Ordering information

Symbols

injury (including loss or life) if the instructions are not followed
| In vitro diagnostic device
| Storage temperature range
| Biohazard – take appropriate precautions
| Keep out of direct sunlight
| Contains sufficient strips for tests
| Use by date
| Product batch code
| Indicates compliance with directives of the European Union
| UK Conformity Assessed marking
| Product manufacturer details
| Authorized representative in the European Union
REF| Catalogue number

Technical assistance

Please contact your local distributor. Refer to https://www.universalbiosensors.com/ for local distributor details.
References

1. Quick A J, Stanley-Brown M, and Bancroft F W: A study of the coagulation defect in hemophilia and in jaundice. Am. J. Med. Sci 190: 501-511, 1935.

2. Kirkwood TB (June 1983). “Calibration of reference thromboplastins and standardization of the prothrombin time ratio”. Thrombosis and Haemostasis 49 (3): 238–44.

3. WHO Expert Committee on Biological Standardization.
   Thirty-third Report. Geneva, World Health Organization, 1983 (WHO Technical Report Series, No. 687).

4. Hirsh J, Dalen J E, Anderson DR, Poller L, Bussey H I, Ansell, J, Deykin D: Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 119: 8S-21S, 2001.

5. Funk D M A, Lippi G, and Favaloro E J: Quality standards for sample processing, transportation, and storage in hemostasis testing. Seminars in Thrombosis & Hemostasis 38: 576–585, 2012

REF| 30100 (EU Only)
30101 (UK Only)
---|---
| Universal Biosensors Pty Ltd
1 Corporate Avenue
Rowville, 3178, Victoria, Australia
|  Midmark Europe Sarl
11 rue Emile Zola, BP 2332
F- 38033 Grenoble Cedex 2, France
| UK Responsible Person:
Obelis UK Ltd Sandford Gate, East Point Business Park, Oxford OX4 6LB United Kingdom

2022 Universal Biosensors. Xprecia Prime™ is a trademark of Universal Biosensors. All rights reserved.
All other trademarks are the property of their respective owners.
79016 v1.5.2
DATE OF ISSUANCE JULY 2022
MADE IN AUSTRALIA

Documents / Resources

| Universal Biosensors Xprecia Prime PT or INR Test Strips [pdf] Instructions
Xprecia Prime, PT or INR Test Strips, Xprecia Prime PT or INR Test Strips, INR Test Strips, PT Test Strips, Strips
---|---

References

• Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratory Portal | CDC
• Universal Biosensors Australia

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