SensoLite Nova Test
Test strips for blood glucose level determination
Test strips for quantitative measurement of glucose concentration in the whole blood with the glucometers SensoLite Nova and SensoLite Nova Plus.
The package contains:
- 25 or 50 strips in a container
- Code setting strip
- User Manual
- Measuring range
- SensoLite Nova system measuring range 1.1 – 33.3 mmol/l (20 - 600 mg/dl)
Sample volume
One drop of blood will be enough for blood glucose level determination with SensoLite Nova test strips. Minimum allowable blood sample volume - 0.5 μl.
Precautions
SensoLite Nova test strips are only for in vitro diagnostics.
- Do not use test strips after the expiry date.
- Do not use test strips, if it is damp, rumpled, scratched or damaged in any other way.
- Do not use test strips repeatedly.
- If your symptoms do not relate to the test results – consult your doctor.
- If the test results appear to be lower or higher than expected - repeat the test.
- High or low red blood cells volume (the hematocrit level is over 55% or below 30%) may influence the accurateness of the result.
- Never change the diabetes treatment regimen and do not ignore the disease symptoms without preliminary consultation with doctor.
- Before the first use or before using the strips from the new package – set the strip code.
The SensoLite Nova and SensoLite Nova Plus systems use internal code. The Code strip is included in every test strips package. It contains the coded alphanumerical information about the code of the test strips package. Coding the SensoLite Nova meter means entering the code value which is specified on the sticker of vial of strips. This should be done every time after opening of the new test strips package (with the help of the Code strip or manually). The code you’re entering glucometer must correspond with the code from the sticker or Code strip. For correct code entering study the section: “Strip-Code setting” from the user manual of SensoLite Nova and SensoLite Nova Plus glucometers.
Restrictions
- SensoLite Nova test strips are designed for measurement of glucose concentration in the whole capillary blood. No venous blood or plasma is suitable for accurate monitoring of glucose level.
- Hematocrit level within the range 30 - 55% shall not not influence the test result. High (over 55%) or low (below 30%) hematoctit may negatively influence the accurateness of the measurement results.
- Infants: SensoLite Nova test strips should not be used for infants’ blood tests, because the SensoLite Nova and SensoLite Nova Plus systems were not tested to comply with the infants’ blood rates.
- Do not use fluorine-containing preservatives for blood samples.
- High concentration of some substances in blood (E.g. high concentration of ascorbic acid or uric acid) may influence the accurateness of the result. In such cases, the diagnostic tests results should be interpreted with special attention.
- The presence in blood of levodopa or dopamine, as a result of taking such medicines, may influence the accurateness of the SensoLite Nova and SensoLite Nova Plus tests result (high glucose level).
Validity
The accuracy of the results, received using the SensoLite Nova test strips, was verified by means of comparative clinical researches, with the participation of the patients suffering from diabetes. The control measurements were carried out using other preliminary checked equipment. The blood glucose level in the samples varied from 4.0 mmol/l to 26.4 mmol/l according to control measurements.
Accuracy
The test corresponds with the standard EN ISO 15197:2003
The SensoLite Nova test strips were laboratorytested, using sodium containing (EDTA) fresh venous blood with different glucose level.
The analysis of all conducted researches showed the 3.65% system inaccuracy within one test and the cumulative inaccuracy - 3.42%. The abovementioned demonstrates high accuracy of the SensoLite Nova test systems and test strips.
The official distributor in Ukraine:
TESPRO LLC