VTRUST TD-4279 Glucose 50 Strips

VTRUST TD-4279

Blood glucose test strips for in vitro diagnostic use. Single use.

VTRUST TD-4279 Test Strips, when used in conjunction with the VTRUST TD-4279 Beta Ketone and Glucose Monitoring System, allow for measurement of blood levels by a home user or healthcare professional. The system uses fresh finger whole blood samples. This system is not intended to be used for the diagnosis or screening of diabetes mellitus.
Professionals can use the test strips to test capillary, venous and arterial blood samples; home use is limited to the capillary whole blood test.
EN ISO 15197: 2015 indicates that the results provided by glucose meters fall within ± 15 mg / dL (0.83 mmol / L) of the value of the reference method when the glucose concentration is less than 100 mg / dL ( 5.55mmol / L), and are within ± 15% of the reference method value when the glucose concentration is 100 mg / dL (5.55 mmol / L) or higher. The following tables display how often the VTRUST TD-4279 achieves this goal. The table is based on a study carried out in 160 patients (each patient was tested six times thus obtaining 960 results) to evaluate the performance of the VTRUST TD-4279 instrument system and VTRUST TD-4279 (TD-4330) strips compared to the YSI reference method -2300.

Accuracy of results for glucose concentrations <100 mg / dL (5.55 mmol / L) Within ± 5mg / 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)

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 testing.
Insert the test strip all the way into the slot on the meter until it proceeds further. When the strip is fully inserted, the meter will perform several checks. Collect an approximately 0.5 microliter blood sample with the test strip. Sufficient blood must be applied for accurate results. Bring the drop of blood into contact with 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 start counting down. After a few seconds the meter will display the blood glucose value. The last reading will be automatically saved in the instrument. Turn off the device by removing the test strip and throw away the test strip.
The test results may be incorrect if the contact bar is not fully seated in the slot.
The front of the test strip should face up when it is inserted into the meter.
Blood glucose readings provide plasma equivalent results and are displayed in milligrams / deciliter (mg / dL). The measuring range of this instrument is 20-600 mg / dL (1.1-33.3 mmol / L).

Please consult your physician to determine a reference range that best suits your patient.

If the test results are unusual or inconsistent with how the patient is feeling:
- make sure that the test strip confirmation window is completely filled with blood;
- check the expiration date of the test strips;
- check the performance of the meter and test strips with the control solutions.
The control solutions contain a known amount of glucose that can react with the test strips. You can check the performance of the meter, the test strips, and the test procedure by comparing the results obtained with the control solutions to the range printed on the test strip bottle label or packaging. Performing quality control testing regularly ensures accurate results. Please refer to the user manual for instructions for performing the control test. The reference range of control solutions may vary with each new bottle or pack of test strips. Be sure to check the range on the bottle label or package.

Components

Glucose dehydrogenase (E. coli) 8%, Redox mediator 55%, Enzyme preservative 8%, Non-reactive substances 29%.

Warnings

For use outside the body only.
The 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, consult a doctor immediately.
Healthcare professionals and any user testing multiple patients with this system should handle everything that comes in contact with blood carefully to avoid the transmission of infectious diseases, including sterilized items.
Do not perform a blood glucose test during or immediately following a xylose absorption test. Blood xylose can give falsely elevated results.
The permitted hematocrit range is between 25% and 55%. Consult your doctor if you do not know the 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 is no significant interference 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 meters (10,742 feet) do not affect the 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 could occur in the following circumstances: severe dehydration due to diabetic ketoacidosis or due to stress-related hyperglycemia, such as non-ketotic hyperosmolar, shock, NYHA Class IV heart failure or peripheral arterial occlusive disease.
Use heparin only as an anticoagulant for capillary or venous whole blood.
Unusually high or low blood sugar levels can indicate a serious medical condition. If most of the 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 bottle. Close the bottle only after taking the strip. Always keep the bottle 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 the 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 meter can produce elevated glucose results:

storage

Store the test strips only in their original bottle out of 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 disposable test strips.
Cod. 3800580LV