Uric Acid Test Strips

Please download the uric acid test strips PDF file here:

Uric Acid Test Strip

This article is for the purpose of use the Uric acid test Meter

IMPORTANT: Please read this instruction and user’s manual before using Uric Acid Test Strip .

How To Use Uric Acid Test Strip

Intended Use

• Measuring uric acid level in capillary whole blood from fingertip.
• The meter can be used by laypersons or healthcare professionals.
• in vitro diagnostic use only.

Principle of the Test

• Electrochemical biosensor technology.

Chemical Composition of Strip

• Wetting agent: cellulose
• Other ingredients (buffer, surfactant, etc.): ≥ 0.01 mg

Storage and Handling

• Storage the strips within 4-30˚C (39-86˚F), use within 3 months after first open.
• Handle the strips with dry and clean hand.
• Recap strip vial immediately after use.
• Use the strip immediately after taking out from the vial.
• Do not use expired strips. It may cause false result.
• Do not expose the strips under sunlight, heat or humid environment.
• Do not repack, change vial, refrigerate or freeze the strips.
• Do not bend, cut or fold the strips.

Auto Strip Recognition

• Please refer to User’s Manual for more information.

Coding Procedure

1. Step1. Insert the Code Strip
2. Step2. Code Number and Test Mode Display on Screen
3. Step3. Make Sure the Code on Screen/ Code Strip/ Strip Vial Label is the Same
4. Step4. Make Sure Test Mode on Top of Screen Display “UA”

How to Perform a Test

1. Step1. Take a Strip
2. Step2. Recap Strip Vial Immediately
3. Step3. Insert the Strip
4. Step4. Make sure the Code is Correct
5. Step5. Sampling by Lancing Device
6. Step6. Touch the Blood Sample with Strip
7. Step7. Result will Show after Count Down
8. Step8. Discard Used Strip and Lancet to Waste Container Please refer to User’s Manual for detail procedure.

IMPORTANT: Please double check the test mode before testing.

Test Results

• Measuring Range: 3-20 mg/dL (0.18-1.19 mmol/L)
• The Normal Range for Healthy Male: 3.4-7.0 mg/dL (0.2-0.42 mmol/L)
  The Normal Range for Healthy Female: 2.4-6.0 mg/dL (0.14-0.36 mmol/L) (The range is only a reference.)

• If “Lo” is displayed on the meter, uric acid level may be below 3 mg/dL (0.18 mmol/L).
• If “Hi” is displayed on the meter, uric acid level may be over 20 mg/dL (1.19 mmol/L).

If the test result is unusually low, high or inconsistent with how you feel, please check the follows and repeat the test again with a new strip and make sure you have followed the instructions carefully.

• Strips are not expired.
• Meter has been coded properly, and the code number is consistent with the strip.
• Meter and strips is working properly.
• Blood sample has filled up the strip inlet sufficiently.

If you still have doubt with the test result, please consult healthcare professional or contact authorized distributor.

IMPORTANT:
· Please consult healthcare professional before making medical decision based on the tested results.
· Strips from other brand are not compatible to BeneCheck’s meter.
· POTENTIAL BIOHAZARD. The used test materials could be sources of infection, please beware especially when the system is used by multiple users.

Control Solution Test

Control solution is used to check the performance of the system. If the control solution test result falls within the range listed on the strip vial label, the system is working properly. Control solution is not included in the system. Please contact an authorized distributor for purchasing. A control test should be performed:

• When the system does not work properly.
• When the test result is unusual or inconsistent.

Out of range control solution test result may be caused by:

• Performing the test inaccurately.
• Contaminated or expired control solution.
• System deterioration or malfunction.
• The codes between meter and strip are inconsistent.

IMPORTANT: Each strip vial might have different control range. Please check every time when you perform a control solution test. Do not use the system if the control solution tests keep result wrongly. Please contact authorized distributor for assistance.

Limitations

For getting an accurate test result, please read the following limitation carefully.

• Single use only. Do not reuse the strips.
• Do not perform the test under strong electronic field with signal interference.
• Do not perform the test on newborns.
• The test strip can be used at altitude up to 10,000 feet (3048 meters).
• Hematocrit (Hct) should be between 30-55%.
• Use only fresh capillary whole blood from fingertip.
• Do not use serum, plasma or venous whole blood.

Additional Information for Healthcare Professionals

• When using venous whole blood for tests, please collect with heparin-containing test tube within 30mins after drawing. Test tubes contain EDTA or Sodium Fluoride may affect test result. Test tubes contain Sodium Citrate will not affect test result.
• Interferences: Acetaminophen, Allopurinol, Amiloride, Ascorbic acid, Atenolol, Bilirubin, Creatinine, Colchicine, Diclofenac, Glibenclamide, Ibuprofen, Indomethacin, Ketoprofen, Metformin, Methyldopa, Salicylate (Aspirin), Tetracycline, Tolazamide, Tolbutaminde, Glucose, Triglyceride, Cholesterol do not significantly affect the test results. However, abnormally high concentrations in blood may cause inaccurately test results.
• Gentisic acid at therapeutic levels (5 mg/dL) may affect the test result.
• Decreased peripheral blood flow may case false results. Ex: severe dehydration, in shock, or in a hyperosmolar state (with or without ketosis), hypotension.
• Cholesterol levels up to 322 mg/dL (8.34 mmol/L) do not affect the results.
• Triglyceride level over 1500 mg/dL (16.94 mmol/L) is not recommended for testing with uric acid test strips.
• Glucose levels up to 503 mg/dL(27.9 mmol/L) do not have significant interference on uric acid test.
• The test strips are not recommended for critically ill patients.

Accuracy

The accuracy of the uric acid test was performed with capillary finger blood and compared with reference instrument calibrators, which were referenced to the NIST SRM 913 Standard. At uric acid concentration <5 mg/dL (<0.30 mmol/L) 95% of test results fall within ±20% bias interval compared to the reference instrument. The three lots have correlation coefficients (R²) of 0.9276, 0.9399 and 0.9309.

At uric acid concentration <5 mg/dL (<0.30 mmol/L)

At uric acid concentration ≧5 mg/dL (≧0.30 mmol/L)

Precision

Repeatability:

Intermediate precision:

Symbols

Please refer to User’s Manual for more information.