FORA B-Ketone Test Strip Instructions
- June 6, 2024
- FORA
Table of Contents
FORA B-Ketone Test Strip
Warnings
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For in vitro diagnostic use (for use outside of the body only).
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For single use only.
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Healthcare professionals and other users testing multiple patients with this systemshould handle everything that has comes into contact with human blood carefully to prevent transmitting infectious diseases, including sanitized objects.
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Please read this sheet and your FORA 6 Plus / FORA 6 Connect Multi-functional meter Owner’s Manual before you use this test strip.
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Use only FORA 6 β-Ketone test strips with FORA 6 Plus / FORA 6 Connect
Multi-functional meter to obtain accurate results, and be covered by the manufacturer’s warranty. -
Results may be inaccurate when testing on patients with abnormally low bloodpressure or those who are in shock.
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Please do not use FORA 6 Plus / FORA 6 Connect Multi-functional monitoring system on critically ill patients. The collection of capillary blood from the approved sample sites is not advised when the peripheral circulation is impaired as the delivery of physiological β-Ketone level might not be a true reflection. The following circumstances may apply: severe dehydration as a result of diabetic ketoacidosis or due to stress hyperglycemic, hyperosmolar non-ketotic coma, shock, decompensated heart failure NYHA Class IV or peripheral arterial occlusive disease.
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Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for advice.
Intended Use
FORA 6 β-Ketone test strips, when used together with FORA 6 Plus / FORA 6 Connect Multi-functional meter, allow your β-Ketone levels to be measured by yourself at home or by healthcare professionals. It uses fresh whole blood samples from the finger. This system is not intended for use in the diagnosis or screening of diabetes mellitus.
Professionals may test with capillary and venous blood sample; home use is limited to capillary whole blood testing. Use ONLY heparin for anticoagulation of whole blood KBKBsamples. Please do NOT use EDTA for anticoagulation.
Contents
Limitations
- Hematocrit: The hematocrit level is limited to between 10% and 70%. Please ask your healthcare professional if you do not know your hematocrit level.
- Neonatal Use: This test strip must not be used for the testing of newborns.
- This test strip is used for testing fresh capillary and venous.
- Altitude Effects: Altitudes up to 10,742 feet (3,275 m) do not affect test results. Please see Appendix: Summary of substances and concentrations in excess of limitation with interference.
Storage and Handling
IMPORTANT: Do not use the test strips if they have expired.
- Use each test strip immediately after taking it out of the vial. Close the vial immediately after taking out a strip. Keep the vial closed at all times.
- Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other containers.
- Do not touch the test strips with wet hands.
- Do not bend, cut, or alter the test strip.
- Store the test strips in a cool, dry place between 2°C and 30°C (35.6°F and 86°F) and below 85% relative humidity.
- Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.
Testing Your β-Ketone
PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTS.
Please refer to your Owner’s Manual for more information.
The used lancet and test strip are potentially biohazardous. Please dispose of
them carefully according to your local regulations.
Reading Your Result
- The β-Ketone readings deliver plasma equivalent results and are displayed in millimoles of β-Ketone per liter of blood (mmol/L).
- The β-Ketone test measures β-Hydroxybutyrate (β-OHB), the most important of the three β-Ketone bodies in the blood. Normally, levels of β-OHB are expected to be less than 0.6 mmol/L.
- β-OHB levels may increase if a person fasts, exercises vigorously or has diabetes and becomes ill. If your β-Ketone result is 0.0 mmol/L, repeat the β-Ketone test with new test strips. If the same message appears again or the result does not reflect how you feel, contact your healthcare professional. Follow your healthcare professional’s advice before you make any changes to your diabetes medication programme. If your β-Ketone result is between 0.6 and 1.5 mmol/L, this may indicate development of a problem that could require medical assistance. Follow your healthcare professional’s instructions. If your β-Ketone result is higher than 1.5 mmol/L, contact your healthcare professional promptly for assistance. You may be at risk of developing diabetic ketoacidosis (DKA).1-6
- Please consult your doctor to determine a target range that works best for you.
Questionable or inconsistent results
If your test results are unusual or inconsistent with how you are feeling:
- Make sure the confirmation window of the test strip is completely filled with blood.
- Check the expiry date of the test strips.
- Check the performance of your meter and test strip with the control solutions.
- Make sure your monitor has correct coding, and the code is the same as the code printed on the individual foil packet you are using.
Please Note: Unusually high or low β-Ketone levels may be symptoms of a serious medical condition. If most of your results are unusually high or low, please contact your healthcare professional.
Quality Control Testing
Our control solutions contain a known amount of β-Ketone that can react with test strips. You can check the performance of the meter, test strip and your technique by comparing the control solution results with the range printed on the label of vial or individual foil pack. Checking regularly can ensure your test results are accurate. Please refer to the Owner’s Manual for complete testing instructions.
IMPORTANT: The reference range of the control solutions may vary with each new test strip. Make sure you check the range on the label of vial or individual foil pack of your current test strip.
Chemical Components
- β-Hydroxybutyrate Dehydrogenase (Pseudomonas sp.) ≧0.5 U
- Mediator 55%
- NAD ≧ 0.5 μg
- Enzyme protector 8%
- Non-reactive ingredients 29%
Additional Information for Healthcare Professionals
Always wear gloves and follow your facility’s biohazard control policy and
procedures when performing tests involving patient blood samples. Use fresh
whole blood samples only. Professionals may use test strips to test capillary
and venous whole blood. Sample Size: 0.8 μL Reaction Time: 10 seconds
System Measurement Range: 0.1 mmol/L to 8 mmol/L
Hematocrit Range: 10 % to 70 %
Accuracy
The table below displays how often FORA achieves this target. The chart is
based on a study carried out on 160 patients (each patient was tested three
times which resulted in 480 test results) to see how well FORA performed
compared to β-Hydroxybutyrate LiquiColor® reference method results.
Capillary samples (n=480)| β-ketone concentration (mmol/L)| Regression
analysis
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Range: 0.10 to 6.75
Mean: 1.13
| y = 0.9997x – 0.0153, R² = 0.9912
Venous samples (n=480)| β-ketone concentration (mmol/L)| Regression analysis
Range: 0.10 to 6.75
Mean: 1.12
| y = 0.9926x – 0.0554, R² = 0.9772
Precision
In repeatability test, the standard deviation (SD) is within 0.1 mmol/L for
each β-Ketone concentration < 1 mmol/L and the coefficient of variation (CV)
is less than 7.5% for each β-Ketone concentration ≥ 1 mmol/L.
For self-testing RFE ACS053
Use only with FORA 6 Plus / FORA 6 Connect Multi-functional meter
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