Description
Blood glucose test strips for in vitro diagnostic use. Disposable.
VTRUST TD-4279 test strips, when used with the VTRUST TD-4279 glucose and beta ketone monitoring system, allow for the measurement of blood levels by a home user or by healthcare professionals. The system uses fresh whole blood samples taken from the fingertip. This system is not intended for use in 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 testing capillary whole blood.
EN ISO 15197:2015 states that results provided by glucometers should fall 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, yielding 960 results) to evaluate the performance of the VTRUST TD-4279 instrument 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.

Instructions for use
Wash and dry hands before performing the test.
Insert the test strip completely into the instrument slot until it goes no further. When the strip is fully inserted, the instrument will perform several checks. Collect a blood sample of approximately 0.5 microliters with the test strip. A sufficient amount of blood must be applied to obtain accurate results. Bring the blood drop into contact with the absorbent hole of the test strip and wait until the confirmation window is completely filled. Do not apply a blood sample from the fingertip by smearing it on the strip. The device will start counting down. After a few seconds, the instrument 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 discard 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 must face upwards when inserted into the instrument.
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).

Time of day	Normal plasma glucose reference values for non-diabetics
Fasting and before a meal	< 100 mg/dL (5.6 mmol/L)
2 hours after meals	< 140 mg/dL (7.8 mmol/L)

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

If test results are unusual or inconsistent with how the patient feels:
- ensure that the confirmation window of 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 can react with the test strips. You can check the performance of the instrument, test strips, and the testing procedure by comparing the results obtained with the control solutions with the range printed on the test strip vial label or packaging. Performing regular quality control tests ensures accurate results. Please refer to the user manual for control test instructions. The reference range of control solutions may vary with each new vial or package of test strips. Be sure to check the range on the vial label or packaging.

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, consult a doctor immediately.
Healthcare personnel and any user performing tests on multiple patients with this system should carefully handle anything that comes into contact with blood to prevent the transmission of infectious diseases, including sterilized objects.
Do not perform blood glucose testing during or immediately after a xylose absorption test. Xylose in the blood can give falsely elevated results.
The permitted 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 concentrations.
No significant interference from galactose, maltose, or fructose has been 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 feet) do not affect test results.
For patients with impaired peripheral circulation, it is not recommended to collect blood from the approved collection site as 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 hyperglycemia, such as hyperosmolar non-ketotic, 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 glucose levels can be an indication of a serious medical condition. If most 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. Keep the vial closed at all times.
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 performing tests on 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 limit value when tested with the VTRUST TD-4279 glucometer, can 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

Storage
Store test strips only in their original vial away from direct sunlight in a cool, dry place with a temperature between 2 °C and 30 °C and a relative humidity below 85%.
Post-opening validity: 24 months.

Format
Pack containing 25 disposable test strips.

Code. 3800530V