ACCUREX XPRESSGLUCO Blood Glucose Test Strips User Manual

ACCUREX XPRESSGLUCO Blood Glucose Test Strips

Specifications

• Test strip type: XPRESSGLUCO+ Blood Glucose Test Strips
• Intended use: Self-testing by people with diabetes at home and healthcare professionals in a clinical setting
• Sample types: Capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf, or thigh
• Testing method: In vitro diagnostic use only
• Sample volume: 0.5 L
• Test result time: 5 seconds
• Test range: 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L)
• Resolution: 1 mg/dL (0.1 mmol/L)

Usage Instructions

Step 1: Preparing the Test Strip

1. Wash your hands thoroughly.
2. Take a test strip out of the packaging.
3. Close the packaging tightly to prevent moisture exposure.

Step 2: Inserting the Test Strip into the Glucose Meter

1. Turn on the XPRESSGLUCO+ Blood Glucose Meter.
2. Ensure that the meter screen is clear and ready for testing.
3. Insert the test strip into the meter’s test strip slot, making sure that the contact bars on the strip are fully inserted.

Step 3: Collecting the Blood Sample

1. Select a suitable site for blood collection (fingertip, forearm, upper arm, palm, calf, or thigh).
2. Prepare the site by cleaning it with an alcohol swab and allowing it to dry.
3. Prick the selected site using a lancet device according to the device’s instructions.
4. Gently squeeze the finger or apply pressure to the selected site to obtain a small drop of blood.

Step 4: Applying the Blood Sample to the Test Strip

1. Touch the edge of the test strip to the blood drop until the strip absorbs an adequate amount of blood.
2. A beep or visual indication on the meter will confirm that enough blood has been applied.
3. Do not smear or scrape the blood across the strip.

Step 5: Reading the Test Result

1. Wait for the meter to process the blood sample.
2. The blood glucose level will be displayed on the meter’s screen.
3. Record the result in a logbook or follow any additional instructions provided by your healthcare professional.

FAQ

Q: Can I use these test strips for diagnosing diabetes?

A: No, these test strips are not intended for diagnosing diabetes. They are meant for monitoring glucose concentrations in individuals with diabetes.

Q: Can I use these test strips on newborns?

A: No, these test strips should not be used on neonates. They are intended for use by people with diabetes at home and healthcare professionals in a clinical setting.

Q: Can I change my medication based on the test results?

A: No, you should not change your medication based on the test results without the advice of a physician or healthcare professional.

Q: Are these test strips validated for testing venous blood specimens?

A: No, XPRESSGLUCO+ Blood Glucose Test Strips are not validated for and should not be used for testing venous blood specimens.

Q: Can certain substances in the blood affect the test results?

A: Yes, certain substances like uric acid, bilirubin, ascorbic acid, and acetaminophen may affect the test results. Please refer to the provided chart for specific concentrations that may cause inaccurate results.

Intended Use

XPRESSGLUCO+ Blood Glucose Test Strips are used with the XPRESSGLUCO+ Blood Glucose Meters. They are intended for self-testing by people with diabetes at home and health care professionals in a clinical setting to monitor glucose concentrations in capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf or thigh. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of diabetes or testing on neonates.

Test Principle

Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level.

Characteristics

Each test strip is plasma-calibrated†, requiring a sample volume of 0.5 μL and taking just 5 seconds to return a test result. The test range is 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L) with resolution at 1 mg/dL (0.1 mmol/L).
†Plasma-calibrated: Test results produced on capillary whole blood samples by XPRESSGLUCO+ System are compared with the results of the corresponding plasma samples tested by the YSI 2300 Glucose Analyzer, calibrated by YSI 2747 Glucose Standard (a NIST traceable glucose standard). The margin of error of the YSI 2300 Glucose Analyzer measurement is 0.289 mg/dL when the blood glucose concentration is higher than 100 mg/dL, or 0.029 mg/dL when the blood glucose concentration is lower than 100 mg/dL. (1 mmol/L= 18 mg/dL).

Limitations of the System

XPRESSGLUCO+ Blood Glucose Test Strips provide accurate results when the following considerations are observed:

• Use fresh capillary whole blood only. Do not use serum or plasma.
• The device cannot be used on neonates.
• The test strips are for single use only. Do not reuse.
• Hematocrit levels below 35% or above 55% can cause inaccurate results. Please consult your doctor if you do not know your hematocrit level.
• Dehydration may cause lower test results. If you are severely dehydrated, contact you physician immediately.
• Testing at altitudes up to 3,402 meters (or 11,161 ft) does not significantly affect results.

Storage and Handling

Please take the following precautions to ensure your XPRESSGLUCO+ Blood Glucose Test Strips are effective.

• Prior to first use, ensure that the package is undamaged and closed.
• Keep the test strip vial away from sunlight and in a cool, dry place between 5 – 40°C (41 – 104°F). Do not freeze it.
• Store test strips in their original pack only. Do not put the test strips in any other container.
• Use test strips immediately after removing from the package.
• Do not use test strips after the expiration date.
• Avoid getting dirt, food or water on the test strip. Do not handle test strips with wet hands. All parts of the test strip should be touched only with dry and clean fingers.
• Do not perform blood glucose tests at a temperature below +10°C (50°F) or above +40°C (104°F), or above 85% relative humidity.
• Close the vial cap tightly immediately after removing a test strip. This keeps the remaining test strips fully functional right up to the expiration date.
• Make a notation of the date on the vial label when you first open it. Discard remaining test strips 180 days after first opening the vial.

Warning

• Discard used test strips and lancets responsibly according to your local regulations.
• Keep test strips vial away from children. A child could choke on the test strips. The test strips and their vial contain agents that may be harmful if swallowed. If they are swallowed, promptly see a doctor for immediate assistance.
• Do not change medication based on the test results without the advice of a physician or healthcare professional.

Additional Information for Healthcare Professionals

1. Follow the infection control procedures appropriate for your facility.
2. XPRESSGLUCO+ Blood Glucose Test Strips are not validated for and should not be used for testing venous blood specimens.
3. Cholesterol concentrations up to 500 mg/dL (12.9 mmol/L) or triglycerides up to 2000 mg/dL (22.6 mmol/L) do not significantly affect test results. However, glucose values in specimens beyond these levels should be interpreted with caution.
4. Inaccurate results may occur on severely hypotensive individuals or patients in shock. Inaccurate results may also occur when individuals are in hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with glucose meters.
5. Interference: Reducing substances occurring in the blood naturally (uric acid, bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will not significantly affect results. The limiting concentration of several compounds are listed in below chart:

Compounds| Concentrations higher than the following values may cause inaccurate results
---|---
Acetaminophen| 8.0 mg/dL (0.53 mmol/L)
Ascorbic Acid| 5.0 mg/dL (0.28 mmol/L)
Aspirin| 60 mg/dL (3.33 mmol/L)
Bilirubin| 90 mg/dL (1.54 mmol/L)
Cholesterol| 500 mg/dL (12.9 mmol/L)
Creatinine| 5.0 mg/dL (0.44 mmol/L)
Dopamine| 2.0 mg/dL (0.11 mmol/L)
EDTA| 360 mg/dL (12.3 mmol/L)
Galactose| 900 mg/dL (50 mmol/L)
Gentisic Acid| 5.0 mg/dL (0.32 mmol/L)
Glutathione| 53 mg/dL (1.72 mmol/L)
Haemoglobin| 500 mg/dL (0.08 mmol/L)
Heparin| 8,000 U/dL
Hydroxyurea| 3.0 mg/dL (0.39 mmol/L)
Ibuprofen| 50 mg/dL (2.42 mmol/L)
Icodextrin| 13 mg/dL (0.01 mmol/L)
L-dopa| 10 mg/dL (0.51 mmol/L)
Maltose| 900 mg/dL (26.3 mmol/L)
Methyldopa| 3.0 mg/dL (0.13 mmol/L)
Pralidoxime Iodide| 25 mg/dL (0.94 mmol/L)
Salicylate| 60 mg/dL (4.34 mmol/L)
Tolazamide| 100 mg/dL (3.21 mmol/L)
Tolbutamide| 400 mg/dL (14.8 mmol/L)
Triglycerides| 2,000 mg/dL (22.6 mmol/L)
Uric Acid| 8.0 mg/dL (0.48 mmol/L)
Xylose| 100 mg/dL (6.66 mmol/L)

Blood Glucose Testing Procedure

See your XPRESS G LUCO + User Guide and accompanying insert for detailed illustrations for all test procedures.

Test Results

• Test results are shown in milligrams of glucose per deciliter of blood (mg/dL) or in millimoles of glucose per liter (mmol/L).
• The meter is capable of displaying test results in the range of 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L). Glucose levels below 60 mg/dL (3.3 mmol/L) 1 or above 240 mg/dL (13.3 mmol/L) 2 may indicate a potentially serious medical condition.
• If your test result is below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L) , please consult your healthcare professional immediately.
• Reference values : The normal adult fasting blood glucose range for a nondiabetic person is Less than 100 mg/dL and less than 140 mg/dL up to 2 hours after meals* 3.
• These are expected values for people without diabetes. Users are to work with their healthcare professional to determine their target blood glucose values.
  • Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.
  • Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.
  • American Diabetes Association Website (http://www.diabetes.org)

Inconsistent Results

• If you are getting test results which are inconsistent with your state of wellness or how you feel, please do the following:
  Make sure the blood sample applied completely fills the test strip channel. • Check that the test strips have not expired.

• Verify the performance of the meter and the test strips using the control solution.
  Consult your doctor if you continue getting the same high or low results.

Quality Control (QC) Testing

• Run a control test anytime you want to check the performance of the meter, the test strip or your testing technique. Only use XPRESS G LUCO + Control Solution. These control solution is designed specifically for use with the system. The control results should fall within the control ranges printed on the test strip bottle.
• Important: the control solution range may vary with each new box of test strips. Always use the control range on the label of your current vial of test strips.

Performance Characteristics

Intermediate precision

Repeatability

System Accuracy :

For glucose concentration <100 mg/dL

Within±5 mg/dL (Within±0.28mmol/L)| Within±10 mg/dL (Within±0.56mmol/L)| Within±15 mg/dL (Within±0.83mmol/L)
---|---|---
104/9180(57.8%)| 166/180(92.2%)| 178/180(98.9%)

For glucose concentration > 100 mg/dL

For glucose concentrations between 45.5 mg/dL and 457 mg/dL

Within±15 mg/dL or ±15%

Within±0.83 mg/dL or ±15%
586/600 (97.7%)

The XPRESS G LUCO + Blood Glucose Monitoring System meets the requirements for System Accuracy as stated in ISO 15197:2013.

User Performance

A study evaluating glucose values from nger tip, palm, forearm, upper arm, calf, and thigh capillary blood samples obtained by 100 lay persons showed the following results: Fingertip 100% / palm 100% / forearm 100% / upperarm 100% / calf 100% / thigh 100% within ± 15 mg/dL (± 0.83 mmol/ L) of the medical laboratory values at glucose concentrations below 100 mg/dL (5.55 mmol/L), and ngertip 98.6% / palm 100% / forearm 100% / upperarm 100% / calf 100% / thigh 100% within ±15 % of the medical laboratory values at glucose concentrations at or above 100mg/dL (5.55 mmol/L).

ACCUREX BIOMEDICAL PVT. LTD.
C28, I-Hub building, AMTZ Campus, Pragati Maidan, M Steel Project S.O., Vishakhapatnam, Andhra Pradesh – 530031 Customer Support No: 1800 209 8456
Tel: +91 96078 99114 •
Email: info@accurex.net
URL: www.accurex.net

References

• Biochemistry Reagents & Analyzers | In Vitro Diagnostic | Accurex

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