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Warnings and precautions
Sample collection and preparation
SensoLite Nova Test SensoLite Nova Test blood glucose strips are for Preparation
IN VITRO diagnostic use only (external use only).
SensoLite Nova Test blood glucose strips are designed
Blood Glucose Test Strip
• Do not use test strips after their expiration date.
specifically for use with fresh capillary whole blood taken from • Do not use test strips that are wet, bent, scratched,
fingertip or earlobe. Venous blood, plasma, or serum samples cannot be used. Blood testing must be performed immediately • Do not re-use the strips.
after the sample is obtained. Common anticoagulants and Test strips for quantitative measurement of glucose concentration • If you have symptoms which are not consistent with your
preservatives such as heparine and sodium EDTA are allowed in whole blood using with the SensoLite Nova and
blood test results always contact your health care professional to be used, but fluoride preservatives should be avoided.
SensoLite Nova Plus blood glucose meter.
Testing your blood
Before you begin
• If your reading result is above or below your expected
Refer to information described in chapter „Measuring with the Carefully read this entire guide. If you have any question range of blood glucose values, always repeat the test meter” of the Instructions for Use of the SensoLite Nova and
and/or need assistance, please, contact our authorised and prove that the values are consistent.
SensoLite Nova Plus meters.
• Abnormal red blood cell quantity (hematocrit below 30% or
above 55%) may cause incorrect results.
Used strip and lancet are contaminated with
• Never make significant changes in your diabetes treatment
blood. Be careful, follow the relevant, local
SensoLite Nova blood glucose test strip was designed to
program or ignore symptoms without consulting your instructions when you throw the used strip and
provide an easy, accurate method for the determination of lancet away.
capillary whole blood glucose content. This analysis applies • You must calibrate (code) the meter before the first use of
the enzyme glucose oxidase and is based on advanced Quality Control
the system or when a new box of test strips is to be used.
electromechanical technology that is specific for ß-D-glucose It is recommended to run the quality control test in (see
“SensoLite Nova and SensoLite Nova Plus system checking”
measurement. Test strips are designed in such a way that SensoLite Nova and SensoLite Nova Plus systems use
blood sample absorbs into the reaction zone, after blood has internal coding system. A Code-card, being included in
the test strip package, holds encoded alfanumerical infor-
• When your test results do not agree with your expectation
been applied to the tip of test strip. In the reagent zone glucose mation that matches the Code value being affixed to
oxidase triggers the oxidation of glucose in blood. Intensity of the bottle of test strips. Setting the code in the meter
• When the test strips have been exposed to temperature,
formed electrons is measured by the meter and correlates means entering the same code value into SensoLite Nova
not conforming to prescribed storage conditions (8°C to well with the concentration of glucose in the blood sample.
glucose meter that is written on the strips’ bottle
Package contents
label whenever you open a new bottle of test strips
• When you open a new bottle of test strips.
• 10, 25 or 50 strips in a vial
(either by using the Code-card, or manually). The code
• If the meter has been dropped.
• Code-card
value entered into the meter should match the code value
• At least once per week to verify that the meter and test
• Instructions for use
indicated on the strip bottle’s label and being encoded on
strips are working properly together.
Measuring range
Code-card. On how to enter the code number refer to the
When using Control Solution for system checking apply only Measurement range of SensoLite Nova Test System is
chapter „Strip code setting” in the Instructions for Use of
CareSens Control Solution, designed specifically for this
Sensolite Nova and Sensolite Nova Plus glucose meters.
system. CareSens Control Solution can be obtained from
Manufacturer upon user’s request for additional charge (see Sample volume
Storage and Handling
exact address and phone number of manufacturer at the end One blood drop is enough to determine blood glucose value with SensoLite Nova Test blood glucose strips are packaged in
of this manual). Other control fluids provide incorrect results, SensoLite Nova Test strip. Minimum sample volume is 0.5 μl.
bottles. Store test strips at temperature between 8°C and therefore cannot be used. When control solutions are used, Reagents
30°C (47°F-and 86°F) and between 30-70% relative humidity test results should be within the expected range indicated on Each test strip contains the following ingredients in the and far from direct sunlight. Do not refrigerate or freeze. When test strips bottle (L1, L2). Test results being within the given stored properly, the unopened test strips are stable until the range, indicate that the system (your meter and test strips) is • Glucose oxidase
expiration date, indicated on the bottle. The month indicated, working properly. If test results obtained with control solution are not within the indicated range, always repeat the control refers to the END of that month. Use the strips within solution test. If the incorrect result still stands, contact your 3 months after first opening of their bottles. Never touch the Each vial cap contains 2-3 g silica gel.
test strips with wet or contaminated hands.
Test results
• Therapeutic levels of tetracycline may result inaccurate
Blood glucose test results are shown on the meter's LCD display in either mg/dl or mmol/l measurement unit. Units can • Therapeutic levels of acetylsalicylic acid(e.g.: Aspirin) may
be set prior the tests (see chapter “Selecting measurement result inaccurate(decreased) glucose readings.
unit” in Instructions for Use of SensoLite Nova or SensoLite Nova
Plus). The exchange rate of the units is: 1 mmol/l = 18 mg/dl.
Accuracy
If you get an unusual test result, always check the physical Accuracy of SensoLite Nova Test strip was assessed by
comparison of patients with diabetes in one tipical clinical 1. Check if the drop of blood is completely fills the reaction
evaluation. Reference measurements were done by another approved blood glucose monitor. Specimens ranged from 1.0 mmol/l to 26.4 mmol/l, as measured by the reference method.
The linear regression data from one tipical clinical site studyis presented in the table below.
2. Check if the expiration date indicated on the test strips bottle
3. Check if the code number of the test strip in use matches
4. Check meter ability to function properly with the „Check
Precision
Test based on Standard EN ISO 15197:2003. 5. Check the system performance with CareSens Control
A laboratory study was conducted with SensoLite Nova Test
Solution.
strip using fresh sodium EDTA venous blood with a broad When test results are still questionable or inconsistent, and range of glucose levels. Results from a single typical run of your blood glucose results are less than 50 mg/dl (2.8 mmol/l) this study, shown in the table, exhibit excellent precision or greater than 300 mg/dl (16.7 mmol/l), consult your health characteristics for SensoLite Nova Test strip. From all the
care professional before making any changes in your studies taken together, estimates of system precision were calculated within-run precision, 3.65% between run precision, Limitations
• SensoLite Nova Test strip is designed to be used with
fresh capillary whole blood samples. NEVER use serum Hematocrit variation in sample: hematocrit between 30% to 55% have no significant effect on test results. Very high (above 55%) and very low (below 30%) hematocrits may cause inaccurate test results.
• Neonates: Do not use SensoLite Nova Test strip to test
neonates. The performance of SensoLite Nova and
SensoLite Nova Plus system has not been validated with
neonatal samples.
References:
• Do not use fluoride as a preservative in blood samples.
N.Tietz, Fundamentals of Clinical Chemistry, • Abnormal blood specimens (i.e., high ascorbic acid, high
uric acid) may effect test results. Blood glucose readings A.E.G. Cass, Biosensors: A practical approach, in these cases should be interpreted for diagnoses with D. Schade, „101 Tips for Improving your blood sugar", p 4-5.

Source: http://en.e77.hu/attachments/docs/sensolitenova_test_um.pdf