FORA 6 Uric Acid Test Strip Instruction Manual

FORA 6 Uric Acid Test Strip

Product Information

The product is a Uric Acid Test Strip designed for in vitro diagnostic use. It is intended for single-use only and is used in conjunction with the FORA 6 Plus / Connect Multi-functional Monitoring System. The test strips are used to quantitatively measure uric acid in fresh capillary whole blood from the finger. Healthcare professionals may also use capillary and venous blood samples, but home use is limited to capillary whole blood testing. The test strips should be stored in their original vial, away from direct sunlight and high humidity.

Warnings

• For in vitro diagnostic use (for use outside of the body only).
• For single use only.
• Healthcare professionals and other users testing multiple patients with this system should handle everything that has come into contact with human blood carefully to prevent transmitting infectious diseases, including sanitized objects.
• Please read this sheet and your FORA 6 Plus / Connect Multi-functional Monitoring System Owner’s Manual before you use this test strip. Use only FORA 6 Test Strips with FORA 6 Plus / Connect Multi-functional Monitoring System to obtain accurate results, and be covered by the manufacturer’s warranty.
• Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are in shock.
• Please do not use FORA 6 Plus / 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 Uric Acid level might not be a true reflection.
• Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for advice.

Intended Use

FORA 6 test strips, when used together with FORA 6 Plus / Connect Multi- functional Monitoring System is intended for the quantitative measurement of uric acid in fresh
capillary whole blood from the finger. It is for in vitro diagnostic use only.
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 samples. Please do NOT use EDTA for anticoagulation.

Contents

1. Uric acid test strips
2. Code strip
3. Instruction for use

Limitations

• Hematocrit: The hematocrit level is limited to between 20% and 60%. 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.
• Metabolites: high concentration of acetaminophen, bilirubin, hemoglobin, methyldopa and ascorbic acid may affect the test results.
• The user is suggested to perform a uric acid test in the morning after fasting for 12 hours.

Storage and Handling

• Use each test strip immediately after taking it out of the vial or individual foil pack. Close the vial immediately after taking out a strip.
• IMPORTANT: Do not use the test strips if they have expired.
• 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 Uric Acid

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

Your uric acid readings deliver plasma equivalent results and is displayed in milligrams of uric acid per deciliter of blood (mg/dL).
The measurement range of this meter is 3 ~ 20 mg/dL (0.179 ~ 1.190 mmol/L).

Reference values

Uric Acid *****

| Male| 3.5 ~ 7.2 mg/dL (0.208 ~ 0.428 mmol/L)
---|---|---
Female| 2.6 ~ 6 mg/dL (0.155 ~ 0.357 mmol/L)

*National Kidney Foundation (2014)
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 vial label or individual foil packet you are using.
  Please Note: 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 uric acid 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 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

• Uric acid catalyst Ú0.15 mg
• Non-reactive ingredients Ú0.05 mg

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: 1.0 L
• Reaction Time: 15 seconds
• System Measurement Range: 3 mg/dL ~ 20 mg/dL (0.179 mmol/L ~1.190 mmol/L)
• Hematocrit Range: 20% ~ 60%

Accuracy

• Results: Difference Plot Analysis
• Model: GD81 / GD82
• Number of subjects (N)=160

TABLE 1: Ratio of samples (capillary whole blood) falling within different bias ranges

• Measurement range: 3.3 ~ 10 mg/dL
• Linear Regression: y = 1.0098x + 0.0095, R² = 0.9637, (n=320)

User Performance

• Results: Difference Plot Analysis
• Model: GD81 / GD82
• Number of subjects (N)=160

TABLE 2: Ratio of samples (capillary whole blood) falling within different bias ranges

• Measurement range: 3.3 ~ 10 mg/dL
• Linear Regression: y = 1.0036x + 0.0499, R² = 0.9633, (n=160)

Precision

TABLE 3: Precision

GD81 / GD82

| Uric Acid Concentration (mg/dL)
---|---
LOW| MID| HIGH
Mean| 5.0| 10.1| 15.0
SD| 0.199| 0.285| 0.452
CV%| 3.97%| 2.83%| 3.01%

Appendix

ForaCare Suisse AG
Neugasse 55, 9000, St. Gallen, Switzerland
www.foracare.ch

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