Description
VTRUST
TD-4279
Description
Blood glucose test strips for in vitro diagnostic use. Single use.
The VTRUST TD-4279 test strips when used in conjunction with the VTRUST TD-4279 Glucose and Beta Ketone Monitoring System, allow measurement of blood levels by a home user or healthcare professionals. The system uses fresh fingerstick whole blood samples. This system is not intended to be used for the diagnosis or screening of diabetes mellitus.
Professionals may use the test strips to test capillary, venous, and arterial blood samples; home use is limited to testing capillary whole blood.
EN ISO 15197:2015 specifies that blood glucose meter results should be within ± 15 mg/dL (0.83 mmol/L) of the reference method value when the glucose concentration is less than 100 mg/dL (5.55 mmol/L), and within ± 15% of the reference method value when the glucose concentration is 100 mg/dL (5.55 mmol/L) or higher. The following tables show how often the VTRUST TD-4279 device achieves this goal. The table is based on a study of 160 patients (each patient was tested six times resulting in 960 results) to evaluate the performance of the VTRUST TD-4279 meter and VTRUST TD-4279 (TD-4330) strips compared to the YSI-2300 reference method.
Accuracy of results for glucose concentrations < 100 mg/dL (5.55 mmol/L)
Accuracy of results for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
Accuracy of results for glucose concentrations between 31.2 mg/dL (1.73 mmol/L) and 537 mg/dL (36.06 mmol/L)
The CV (%) is less than 5% for both intermediate precision and repeatability.
How to use
Wash and dry your hands before performing the test.
Insert the test strip fully into the meter slot until it stops moving. When the strip is fully inserted, the meter will perform several checks. Collect a blood sample of approximately 0.5 microliters with the test strip. You must apply enough blood to get accurate results. Touch the drop of blood to the absorbent hole of the test strip and wait until the confirmation window is completely filled. Do not apply a finger blood sample by smearing it on the strip. The device will begin to count down. After a few seconds, the meter will display your blood glucose value. The last reading will be automatically saved in the meter. Turn off the device by removing the test strip and throw away the test strip.
Test results may be incorrect if the contact bar is not fully inserted into the slot.
The front side of the test strip should face up when inserted into the meter.
Blood glucose readings provide plasma equivalent results and are displayed in milligrams/deciliter (mg/dL). The measurement range of this meter is 20-600 mg/dL (1.1-33.3 mmol/L).
Please consult your doctor to determine a reference range that best suits you.
If the test results are unusual or inconsistent with how the patient feels:
- make sure the confirmation window on the test strip is completely filled with blood;
- check the expiration date of the test strips;
- check the performance of the instrument and test strips with control solutions.
Control solutions contain a known amount of glucose that may react with the test strips. You can check the performance of your meter, test strips, and testing procedure by comparing the results obtained with the control solutions to the range printed on the test strip vial label or on the package. Performing quality control testing regularly ensures accurate results. Please refer to the user manual for control testing instructions. The reference range of control solutions may change with each new vial or box of test strips. Be sure to check the range on the vial label or package.
Components
Glucose dehydrogenase (E. coli) 8%, Redox mediator 55%, Enzyme preservative 8%, Non-reacting substances 29%.
Warnings
For external use only.
Results may be inaccurate if the test is performed on patients with low blood pressure or on patients who are in shock.
Keep both test strips and lancets out of the reach of children. If swallowed, seek medical advice immediately.
Healthcare personnel and any user testing multiple patients with this system should carefully handle anything that comes into contact with blood to avoid transmission of infectious diseases, including sterilized items.
Do not test your blood sugar during or immediately after a xylose absorption test. Xylose in your blood may give falsely elevated results.
The allowable hematocrit range is between 25% and 55%. Consult your doctor if you do not know your hematocrit level.
Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid and paracetamol do not significantly affect blood glucose test results at normal blood concentration.
There are no significant interferences from galactose, maltose or fructose observed in blood glucose tests.
Blood triglyceride concentrations up to 3,000 mg/dL (33.9 mmol/L) do not significantly affect results, but may affect results at higher levels.
Altitudes up to 3,275 m (10,742 ft) do not affect test results.
For patients with impaired peripheral circulation, it is not recommended to collect blood from the approved collection site as the results may not reflect the physiological blood glucose level. This may occur in the following circumstances: severe dehydration due to diabetic ketoacidosis or due to stress hyperglycemia, such as non-ketotic hyperosmolar, shock, NYHA Class IV heart failure, or peripheral arterial occlusive disease.
Use only heparin as an anticoagulant for capillary or venous whole blood.
Unusually high or low blood sugar levels may indicate a serious medical condition. If most of your results are unusually high or low, please contact your doctor.
Do not use expired strips.
Do not touch the test strips with wet hands.
Use the test strip immediately after removing it from the vial. Close the vial only after taking the strip. Always keep the vial closed.
Do not bend, cut, or modify the test strip.
For healthcare professionals: Always wear gloves and follow your facility's biohazard policies and procedures when testing patient blood samples. Use only fresh whole blood samples. Professionals can use test strips to test capillary, venous, and arterial blood samples.
The following compounds when found in excess of their cut-off value when tested with the VTRUST TD-4279 Glucose Meter may generate elevated glucose results:
Conservation
Store test strips only in their original bottle away from direct sunlight in a cool, dry place with a temperature between 2°C and 30°C and a relative humidity of less than 85%.
Validity after opening: 24 months.
Format
Pack containing 50 single-use test strips.
Code 3800580LV
Blood glucose test strips for in vitro diagnostic use. Single use.
The VTRUST TD-4279 test strips when used in conjunction with the VTRUST TD-4279 Glucose and Beta Ketone Monitoring System, allow measurement of blood levels by a home user or healthcare professionals. The system uses fresh fingerstick whole blood samples. This system is not intended to be used for the diagnosis or screening of diabetes mellitus.
Professionals may use the test strips to test capillary, venous, and arterial blood samples; home use is limited to testing capillary whole blood.
EN ISO 15197:2015 specifies that blood glucose meter results should be within ± 15 mg/dL (0.83 mmol/L) of the reference method value when the glucose concentration is less than 100 mg/dL (5.55 mmol/L), and within ± 15% of the reference method value when the glucose concentration is 100 mg/dL (5.55 mmol/L) or higher. The following tables show how often the VTRUST TD-4279 device achieves this goal. The table is based on a study of 160 patients (each patient was tested six times resulting in 960 results) to evaluate the performance of the VTRUST TD-4279 meter and VTRUST TD-4279 (TD-4330) strips compared to the YSI-2300 reference method.
Accuracy of results for glucose concentrations < 100 mg/dL (5.55 mmol/L)
| Within ± 5 mg/dL (Within ± 0.27 mmol/L) |
Within ± 10 mg/dL (Within ± 0.55 mmol/L) |
Within ± 15 mg/dL (Within ± 0.83 mmol/L) |
| 83.3% (270/324) | 100% (324/324) | 100% (324/324) |
Accuracy of results for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
| Within ± 5% | Within ± 10% | Within ± 15% |
| 66.4% (422/636) | 96.9% (616/636) | 100% (636/636) |
Accuracy of results for glucose concentrations between 31.2 mg/dL (1.73 mmol/L) and 537 mg/dL (36.06 mmol/L)
| Within ± 15 mg/dL or ± 15% (Within ±0.83 mmol/L or ±15%) |
| 100% (960/960) |
The CV (%) is less than 5% for both intermediate precision and repeatability.
How to use
Wash and dry your hands before performing the test.
Insert the test strip fully into the meter slot until it stops moving. When the strip is fully inserted, the meter will perform several checks. Collect a blood sample of approximately 0.5 microliters with the test strip. You must apply enough blood to get accurate results. Touch the drop of blood to the absorbent hole of the test strip and wait until the confirmation window is completely filled. Do not apply a finger blood sample by smearing it on the strip. The device will begin to count down. After a few seconds, the meter will display your blood glucose value. The last reading will be automatically saved in the meter. Turn off the device by removing the test strip and throw away the test strip.
Test results may be incorrect if the contact bar is not fully inserted into the slot.
The front side of the test strip should face up when inserted into the meter.
Blood glucose readings provide plasma equivalent results and are displayed in milligrams/deciliter (mg/dL). The measurement range of this meter is 20-600 mg/dL (1.1-33.3 mmol/L).
| Time of day | Normal reference plasma glucose values for non-diabetics |
| On an empty stomach and before a meal | < 100 mg/dL (5.6 mmol/L) |
| 2 hours after meals | < 140 mg/dL (7.8 mmol/L) |
If the test results are unusual or inconsistent with how the patient feels:
- make sure the confirmation window on the test strip is completely filled with blood;
- check the expiration date of the test strips;
- check the performance of the instrument and test strips with control solutions.
Control solutions contain a known amount of glucose that may react with the test strips. You can check the performance of your meter, test strips, and testing procedure by comparing the results obtained with the control solutions to the range printed on the test strip vial label or on the package. Performing quality control testing regularly ensures accurate results. Please refer to the user manual for control testing instructions. The reference range of control solutions may change with each new vial or box of test strips. Be sure to check the range on the vial label or package.
Components
Glucose dehydrogenase (E. coli) 8%, Redox mediator 55%, Enzyme preservative 8%, Non-reacting substances 29%.
Warnings
For external use only.
Results may be inaccurate if the test is performed on patients with low blood pressure or on patients who are in shock.
Keep both test strips and lancets out of the reach of children. If swallowed, seek medical advice immediately.
Healthcare personnel and any user testing multiple patients with this system should carefully handle anything that comes into contact with blood to avoid transmission of infectious diseases, including sterilized items.
Do not test your blood sugar during or immediately after a xylose absorption test. Xylose in your blood may give falsely elevated results.
The allowable hematocrit range is between 25% and 55%. Consult your doctor if you do not know your hematocrit level.
Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid and paracetamol do not significantly affect blood glucose test results at normal blood concentration.
There are no significant interferences from galactose, maltose or fructose observed in blood glucose tests.
Blood triglyceride concentrations up to 3,000 mg/dL (33.9 mmol/L) do not significantly affect results, but may affect results at higher levels.
Altitudes up to 3,275 m (10,742 ft) do not affect test results.
For patients with impaired peripheral circulation, it is not recommended to collect blood from the approved collection site as the results may not reflect the physiological blood glucose level. This may occur in the following circumstances: severe dehydration due to diabetic ketoacidosis or due to stress hyperglycemia, such as non-ketotic hyperosmolar, shock, NYHA Class IV heart failure, or peripheral arterial occlusive disease.
Use only heparin as an anticoagulant for capillary or venous whole blood.
Unusually high or low blood sugar levels may indicate a serious medical condition. If most of your results are unusually high or low, please contact your doctor.
Do not use expired strips.
Do not touch the test strips with wet hands.
Use the test strip immediately after removing it from the vial. Close the vial only after taking the strip. Always keep the vial closed.
Do not bend, cut, or modify the test strip.
For healthcare professionals: Always wear gloves and follow your facility's biohazard policies and procedures when testing patient blood samples. Use only fresh whole blood samples. Professionals can use test strips to test capillary, venous, and arterial blood samples.
The following compounds when found in excess of their cut-off value when tested with the VTRUST TD-4279 Glucose Meter may generate elevated glucose results:
| Substance | Limit concentration (mg/dL) |
Therapeutic/physiological concentration range (or upper limit) (mg/dL) |
| Acetaminophen (Paracetamol) | > 6.25 | 0.45 - 3 |
| Ascorbic Acid | > 5 | 2 |
| Pralidoxime Iodide | > 5 | 10 (IV Dose 500 mg) |
| Uric Acid | > 10 | 2 - 8 |
Conservation
Store test strips only in their original bottle away from direct sunlight in a cool, dry place with a temperature between 2°C and 30°C and a relative humidity of less than 85%.
Validity after opening: 24 months.
Format
Pack containing 50 single-use test strips.
Code 3800580LV
