Total Cholesterol Test Strip

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Total Cholesterol Test Strip

For use with BeneCheck Multi-Monitoring Meter PD-G001-1/ PD-G001-4/ PD-G001-6 and BK6-10M/ BK6-20M/ BK3-10M/ BK3-20M series.

IMPORTANT:
Please read this instruction and user’s manual before using BeneCheck Total Cholesterol Test
Strip (Model: BK-C1).

Intended Use

  • Measuring total cholesterol 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

  • Total Cholesterol esterase: ≥1.5 Unit
  • Total Cholesterol oxidase: ≥2.0 Unit
  • 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. 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 Containe.

Please refer to User’s Manual for detail procedure.

IMPORTANT: Please double check the test mode before testing.

Test Results

  • Measuring Range: 100-400 mg/dL (2.59-10.35 mmol/L)
  • The Normal Range for Healthy Adult: ≤200 mg/dL (5.17 mmol/L). (The range is only a reference.)
  • If “Lo” is displayed on the meter, total cholesterol level may be below 100 mg/dL (2.59 mmol/L).
  • If “Hi” is displayed on the meter, total cholesterol level may be over 400 mg/dL (10.35 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 35-50%.
  • Use only fresh capillary whole blood from fingertip.
  • Do not use serum, plasma or venous whole blood.

Additional Information for Healthcare Professionals

  • Interferences: Acetaminophen, Ascorbic Acid, Bilirubin, Creatinine, Dopamine, Gentistic acid, Glucose, Hemoglobin, Ibuprofen, Methyl DOPA, Salicylate (Aspirin), Uric Acid do not significantl affect the test results. However, abnormally high concentrations in blood may cause inaccurately test results.
  • Decreased peripheral blood flow may case false results. Ex: severe dehydration, in shock, or in a hyperosmolar state (with or without ketosis), hypotension.
  • Triglycerides and grossly lipemic samples have not been tested and are not recommended for testing with total cholesterol test strips.
  • Glucose levels up to 444 mg/dL (24.6 mmol/L) do not have significant interference on total cholesterol test.
  • The test strips are not recommended for critically ill patients.

Accuracy

The accuracy of the total cholesterol test was performed with capillary finger blood and compared with reference instrument calibrators, which were referenced to the NIST SRM 911 Standard. 95% of test results fall within ±20% bias interval compared to the reference instrument. The three lots have correlation coefficients (R2) of 0.9780, 0.9748 and 0.9732.

At total cholesterol concentration <150 mg/dL (<3.89 mmol/L)

Within ± 10 mg/dL
(Within± 0.26mmol/L)
Within ± 15 mg/dL
(Within± 0.39mmol/L)
Within ± 20 mg/dL
(Within± 0.52mmol/L)
Within ± 30 mg/dL
(Within± 0.78mmol/L)
17/42 (40%)24/42 (57%)35/42 (83%)42/42 (100%)

At total cholesterol concentration ≥150 mg/dL (≥3.89 mmol/L)

Within ± 5 %Within ± 10 %Within ± 15 %Within ± 20 %
125/318 (39%)250/318 (79%)318/318 (100%)318/318 (100%)

Precision

Repeatability

Mean (mg/dL)138.6185.8269.8320.1
Mean (mmol/L)3.584.816.988.28
SD (mg/dL)9.311.817.924.8
SD (mmol/L)0.240.300.460.64
CV (%)6.76.36.67.7

Intermediate precision

Mean (mg/dL)151265
Mean (mmol/L)3.906.85
CV (%)1.77.0

Symbols

Please refer to User’s Manual for more information.