Descrizione Clinica
VTRUST
TD-4279
Description
Glycemia reactive strips for in vitro diagnostic use. Disposable.
The reactive strips VTRUST TD-4279 when used together with the glucose monitoring system and beta ketones VTRUST TD-4279, allow the measurement of blood levels by a domestic user or by health professionals. The system uses fresh whole blood samples taken from the finger. This system is not intended to be used for the diagnosis or screening of diabetes mellitus.
Professionals can use reactive strips to test capillary, venous and arterial blood samples; domestic use is limited to the whole capillary blood test.
EN ISO 15197:2015 indicates that the results provided by glucometers fall within ± 15 mg/dL (0.83 mmol/L) compared to the reference method value when glucose concentration is less than 100 mg/dL (5.55 mmol/L), and fall within ± 15% compared to the reference method value when glucose concentration is 100 mg/dL (5.55 mmol/L). The following tables show how often the device is VTRUST TD-4279 achieves this. The table is based on a study carried out on 160 patients (each patient has been tested six times thus obtaining 960 results) to assess system performance VTRUST TD-4279 instrument and VTRUST TD-4279 (TD-4330) strips compared to the reference method YSI-2300.
Accuracy of results for glucose concentrations Within ± 5 mg/dL
(Input ± 0.27 mmol/L) Within ± 10 mg/dL
(Input ± 0.55 mmol/L) Within ± 15 mg/dL
(Input ± 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 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 accuracy and repeatability.
Mode of use
Wash and dry your hands before running the test.
Completely insert the reactive strip into the slot of the instrument until it proceeds further. When the strip is fully inserted, the tool will perform several controls. Collect a blood sample of about 0.5 microliters with the reactive strip. It is necessary to apply a sufficient amount of blood to obtain accurate results. Contact the drop of blood with the absorbent hole of the reactive strip and wait until the confirmation window is completely filled. Do not apply a blood sample from your finger by smearing it on the strip. The device will start the countdown. After a few seconds the instrument will display the value of blood sugar. The last reading will be saved automatically in the tool. Turn off the device by removing the reactive strip and throw away the reactive strip.
The test results may be wrong if the contact bar is not fully inserted in the slot.
The front side of the reactive strip must be turned upward when inserted into the instrument.
Glycemia readings provide equivalent plasma results and are displayed in milligrams/deciliters (mg/dL). The measuring range of this instrument is 20-600 mg/dL (1,1-33,3 mmol/L).
Please consult your doctor to determine a reference range that best suits the patient.
If the test results are unusual or not consistent with what the patient feels:
- make sure that the reactive strip confirmation window is completely filled with blood;
- check the expiry date of the reactive strips;
- control the performance of the instrument and reactive strips with control solutions.
Control solutions contain a known amount of glucose that can react with reactive strips. You can control the performance of the instrument, the reactive strips and the test execution procedure by comparing the results obtained with the control solutions with the printed range on the label of the reactive strip bottle or on the packaging. Making quality control test regularly ensures accurate results. Please refer to the user manual for the control test execution instructions. The reference range of control solutions can vary with each new bottle or reactive strip pack. Make sure to check the range on the bottle label or on the packaging.
Components
Glucose dehydrogenase (E. coli) 8%, Redox Mediator 55%, Enzyme Preservant 8%, Non-reasonable Substances 29%.
Warnings
Only for use outside the body.
Results may be unfulfilled if the test is performed on patients with low blood pressure or on patients who are in shock.
Keep both reactive strips and hands away from children's reach. In case of ingestion, consult a doctor immediately.
Health care personnel and any user who performs the test on multiple patients with this system should carefully handle everything that comes into contact with blood to prevent transmission of infectious diseases, including sterilized objects.
Do not test blood sugar during or immediately after a xylose absorption test. Xylose in the blood can give falsely high results.
The permitted hematocrite range is between 25% and 55%. Consult your doctor if you do not know the level of hematocrite.
Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid and paracetamol do not significantly affect the results of blood glucose testing 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 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 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.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 limit value when tested with the glucometer VTRUST TD-4279 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 disposable reactive strips.
Cod. 3800580
Glycemia reactive strips for in vitro diagnostic use. Disposable.
The reactive strips VTRUST TD-4279 when used together with the glucose monitoring system and beta ketones VTRUST TD-4279, allow the measurement of blood levels by a domestic user or by health professionals. The system uses fresh whole blood samples taken from the finger. This system is not intended to be used for the diagnosis or screening of diabetes mellitus.
Professionals can use reactive strips to test capillary, venous and arterial blood samples; domestic use is limited to the whole capillary blood test.
EN ISO 15197:2015 indicates that the results provided by glucometers fall within ± 15 mg/dL (0.83 mmol/L) compared to the reference method value when glucose concentration is less than 100 mg/dL (5.55 mmol/L), and fall within ± 15% compared to the reference method value when glucose concentration is 100 mg/dL (5.55 mmol/L). The following tables show how often the device is VTRUST TD-4279 achieves this. The table is based on a study carried out on 160 patients (each patient has been tested six times thus obtaining 960 results) to assess system performance VTRUST TD-4279 instrument and VTRUST TD-4279 (TD-4330) strips compared to the reference method YSI-2300.
Accuracy of results for glucose concentrations
(Input ± 0.27 mmol/L)
(Input ± 0.55 mmol/L)
(Input ± 0,83 mmol/L)
Accuracy of results for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
| Within ± 5% | By ± 10% | By ± 15% |
| 66.4% (422/636) | 96.9% (616/636) | 100% (636/636) |
Accuracy of 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% (Input ± 0,83 mmol/L or ± 15%) |
| 100% (960/96) |
The CV (%) is less than 5% for both intermediate accuracy and repeatability.
Mode of use
Wash and dry your hands before running the test.
Completely insert the reactive strip into the slot of the instrument until it proceeds further. When the strip is fully inserted, the tool will perform several controls. Collect a blood sample of about 0.5 microliters with the reactive strip. It is necessary to apply a sufficient amount of blood to obtain accurate results. Contact the drop of blood with the absorbent hole of the reactive strip and wait until the confirmation window is completely filled. Do not apply a blood sample from your finger by smearing it on the strip. The device will start the countdown. After a few seconds the instrument will display the value of blood sugar. The last reading will be saved automatically in the tool. Turn off the device by removing the reactive strip and throw away the reactive strip.
The test results may be wrong if the contact bar is not fully inserted in the slot.
The front side of the reactive strip must be turned upward when inserted into the instrument.
Glycemia readings provide equivalent plasma results and are displayed in milligrams/deciliters (mg/dL). The measuring range of this instrument is 20-600 mg/dL (1,1-33,3 mmol/L).
| Time of the day | Normal reference values of glycemia on plasma for non diabetic |
| Fasting and before a meal | |
| 2 hours after meals |
If the test results are unusual or not consistent with what the patient feels:
- make sure that the reactive strip confirmation window is completely filled with blood;
- check the expiry date of the reactive strips;
- control the performance of the instrument and reactive strips with control solutions.
Control solutions contain a known amount of glucose that can react with reactive strips. You can control the performance of the instrument, the reactive strips and the test execution procedure by comparing the results obtained with the control solutions with the printed range on the label of the reactive strip bottle or on the packaging. Making quality control test regularly ensures accurate results. Please refer to the user manual for the control test execution instructions. The reference range of control solutions can vary with each new bottle or reactive strip pack. Make sure to check the range on the bottle label or on the packaging.
Components
Glucose dehydrogenase (E. coli) 8%, Redox Mediator 55%, Enzyme Preservant 8%, Non-reasonable Substances 29%.
Warnings
Only for use outside the body.
Results may be unfulfilled if the test is performed on patients with low blood pressure or on patients who are in shock.
Keep both reactive strips and hands away from children's reach. In case of ingestion, consult a doctor immediately.
Health care personnel and any user who performs the test on multiple patients with this system should carefully handle everything that comes into contact with blood to prevent transmission of infectious diseases, including sterilized objects.
Do not test blood sugar during or immediately after a xylose absorption test. Xylose in the blood can give falsely high results.
The permitted hematocrite range is between 25% and 55%. Consult your doctor if you do not know the level of hematocrite.
Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid and paracetamol do not significantly affect the results of blood glucose testing 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 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 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.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 limit value when tested with the glucometer VTRUST TD-4279 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 Ioduro | > 5 | 10 (IV) Dose 500 mg) |
| Urico 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 disposable reactive strips.
Cod. 3800580
