AUVON DS-W Draw-In Blood Glucose Test Strips

Summary

The AUVON DS-W Draw-In blood glucose test strip is designed for easy and accurate determination of blood glucose in capillary whole blood. When blood is applied to the reaction zone, it is drawn into the reaction chamber, displaying a reading on the meter. Only a small amount of blood is needed. The test strips are for quantitative measurement of blood glucose in the range of 20-600 mg/dL (1.1-33.3 mmol/L).

Principles of the Procedure

This analysis uses glucose oxidase, an enzyme based on advanced biosensor technology for ẞ-D-glucose measurement. The test strips draw blood samples into the reaction chamber via capillary action. Glucose oxidase catalyzes the oxidation of glucose. The meter measures the intensity of electrons formed, which correlates with the glucose concentration in the blood sample.

Reagents

• 35.6% w/w glucose oxidase
• 41.0% w/w potassium ferricyanide
• 23.4% w/w nonreactive ingredients

Precautions and Warnings

• Use only with the AUVON DS-Series Blood Glucose Meter. Using other brands may cause erroneous results.
• Intended for self-testing and in vitro diagnostic use (external use only).
• Used strips, lancets, and alcohol pads may be infectious. Treat as infectious or biologically hazardous waste.
• Handle all objects that come in contact with human blood with care, as they can transmit viral diseases.
• Glucose oxidase (GO) in the test strips can be affected by oxygen concentration. Use finger prick capillary blood and perform tests under normal atmospheric conditions.
• If test results do not match symptoms, and procedural errors are ruled out, consult a healthcare professional immediately.
• If readings are outside your prescribed range, repeat the test.
• Never make significant changes to your diabetes treatment program or ignore symptoms without consulting your physician.

Storage and Handling

• Do not use test strips after the expiry date.
• Do not use wet, bent, scratched, or damaged test strips.
• Do not re-use test strips.
• Store test strips in the original vial.
• Store at temperatures between 4°C~32°C (40°F~89°F) and below 85% relative humidity.
• Store away from direct sunlight and heat. Do not refrigerate or freeze.
• Perform blood glucose determinations at temperatures between 14°C~40°C (57°F~104°F) and below 85% relative humidity.
• Unopened test strips are stable until the expiry date when stored properly.
• Record the first opening date on the vial label and use within 3 months.
• Always close the vial immediately after use to maintain strip usability.
• Handle test strips with dry, clean hands.

Sample Collection and Preparation

The Draw-In test strips are designed for capillary whole blood. Follow procedures for accurate results:

• Clean and dry hands thoroughly, especially the sample collection site. Ensure it is completely dry if using an alcohol pad.
• Use the provided lancing device for finger pricking. Gently massage the site before pricking to help collect enough blood. Do not over-press the pricked site.
• Do not use venous blood, plasma, or serum samples, as venous blood may yield higher glucose readings due to oxygen content differences.
• Testing must be performed immediately after sample collection.
• Common anticoagulants like heparin and sodium EDTA may be used, but fluoride preservatives must be avoided.
• Minor differences in oxygen content exist between capillaries at various body sites. Use finger pricks for consistent monitoring and comparison.

Testing Your Blood

Refer to the "Measuring Your Blood Glucose Level" section in the meter's User's Guide before testing.

Quality Control (Optional Accessory)

It is recommended to run a quality control test:

• When test results do not agree with how you feel.
• At least once per week to verify meter and test strip functionality.
• Every time a new vial of test strips is opened.
• If the meter is dropped.

Use only AUVON DS-Series Control Solutions. Test results should fall within the expected ranges printed on the test strip vial label. If control results are out of range, repeat the test. Check meter performance with a monitor checker or control solutions as detailed in the User's Guide.

Test Results

Blood glucose results are displayed in mg/dL or mmol/L. To convert: (mg/dL) ÷ 18 = (mmol/L).

If an unusual test result occurs, check the following before repeating the test:

• Ensure the blood drop completely fills the reaction zone.
• Verify the test strip is within its expiration date.
• Confirm the test strip's code number matches the meter's programmed number.
• Check meter performance with the monitor checker.
• Check meter and test strip performance with control solutions.

For questionable or inconsistent results, or if blood glucose is less than 55 mg/dL (2.8 mmol/L) or greater than 300 mg/dL (16.7 mmol/L), consult your healthcare professional before making medication changes.

Limitations

• Designed for fresh capillary whole blood samples only. Do not use serum or plasma.
• Hematocrit variations between 20% and 60% have minimal effect. Very high (>60%) or very low (<20%) hematocrits can cause inaccurate results.
• Not validated for neonates.
• Do not use fluoride or iodoacetic acid as preservatives.
• Abnormal blood specimens (e.g., high ascorbic acid, high uric acid) may affect results. Interpret with caution.
• Therapeutic levels of L-dopa or Dopamine may lead to inaccurate (elevated) glucose readings.

Accuracy

Accuracy was assessed by comparing AUVON DS-W test strips to the YSI 2300 STAT Plus™™ reference method using oxygenated Heparin-venous blood reconstituted with glucose (20-600 mg/dL). Results:

Precision

Precision was evaluated by performing 20 tests for each glucose concentration (40, 80, 160, 275, 400 mg/dL) using oxygenated Heparin-venous blood. Results:

Reference

1. N. Tietz, Fundamentals of Clinical Chemistry, W.B Sanders Co. 1987.
2. A.E.G. Cass, Biosensors: A practical approach, IRL Press, 1990.
3. D. Schade, "101 Tips for Improving Your Blood Sugar" P.4-5

Symbols and Markings

• LOT: Lot number
• IVD: For in vitro diagnostic use
• REF: Catalogue number
• Consult instructions for use: [info symbol] ?
• Use by: [calendar symbol] ?
• Do not re-use: [no-repeat symbol] ?
• CE: Fulfills the requirement of 98/79/EC
• Keep away from sunlight: [sun symbol] ☀️
• Keep dry: [water drop symbol] ?
• Temperature limitation: [thermometer symbol] ?️
• Caution: [exclamation mark symbol] ⚠️
• WEEE: [recycling symbol] ♻️

Distributor Information

Shenzhen Yuwen E-Commerce Co., Ltd.
703 Room, 7F, #153 Zhonghuicai Building
Donghuan 1th Rd. Longhua St, Longhua New District
Shenzhen Guangdong, CN 518000

Product Information

Model Number: DSWCS-SVZAMS-V1.0-220422

Customer Service

24-Month Limited Warranty
Lifetime Technical Support
Phone: +1(678)829-7256
Email: support@iauvon.com