Description
Blood glucose test strips for in vitro diagnostic use. Single-use.
VTRUST TD-4279 test strips, when used with the VTRUST TD-4279 glucose and beta-ketone monitoring system, allow 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 capillary whole blood testing.
EN ISO 15197:2015 indicates that glucose meter results 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 meets this objective. 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 system 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 for 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 fingertip blood sample 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 measurement 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 a 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 test strip confirmation window is completely filled with blood;
- check the expiry 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 testing procedure by comparing the results obtained with the control solutions with the range printed on the test strip bottle label or packaging. Regular quality control testing ensures accurate results. Please refer to the user manual for instructions on how to perform the control test. The reference range of the control solutions may vary with each new bottle or package of test strips. Be sure to check the range on the bottle label or packaging.

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

Warnings
For external use only.
Results may not be accurate 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 testing multiple patients with this system should handle everything that comes into contact with blood carefully to avoid 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 allowed 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 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 hyperosmolar nonketotic, 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 may indicate a serious medical condition. If most results are unusually high or low, please contact your doctor.
Do not use expired strips.
Do not touch test strips with wet hands.
Use the test strip immediately after removing it from the bottle. Close the bottle only after taking the strip. Keep the bottle always closed.
Do not bend, cut, or alter 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 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 bottle away from direct sunlight in a cool, dry place with a temperature between 2°C and 30°C and a relative humidity below 85%.
Validity after opening: 24 months.

Format
Pack containing 50 single-use test strips.

Code. 3800580LV