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Test results

Blood glucose test results are shown on the meter's LCD

display in either mg/dl or mmol/l measurement unit. Units can

be set prior the tests (see chapter “Selecting measurement

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.

If you get an unusual test result, always check the physical

circumstances being applied as follows:

1. Check if the drop of blood is completely fills the reaction

zone.

2. Check if the expiration date indicated on the test strips bottle

is not over yet.

3. Check if the code number of the test strip in use matches

the number set in the meter.

4. Check meter ability to function properly with the „Check

strip”.

5. Check the system performance with CareSens Control

Solution.

When test results are still questionable or inconsistent, and

your blood glucose results are less than 50 mg/dl (2.8 mmol/l)

or greater than 300 mg/dl (16.7 mmol/l), consult your health

care professional before making any changes in your

diabetes medication program.

Limitations

•

SensoLite Nova Test strip is designed to be used with

fresh capillary whole blood samples. NEVER use serum

or plasma samples.

• 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.

• Do not use fluoride as a preservative in blood samples.

• Abnormal blood specimens (i.e., high ascorbic acid, high

uric acid) may effect test results. Blood glucose readings

in these cases should be interpreted for diagnoses with

caution.

• Therapeutic levels of tetracycline may result inaccurate

(decreased) glucose readings.

• Therapeutic levels of acetylsalicylic acid(e.g.: Aspirin) may

result inaccurate(decreased) glucose readings.

Accuracy

Accuracy of SensoLite Nova Test strip was assessed by

comparison of patients with diabetes in one tipical clinical

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 study

is presented in the table below.

Number of Samples: 198

Range (mmol/l): 1.2 - 27.8

Bias (%): -4.45%

Slope: 1.055

Intercept (mmol/l): -0.7182

Correlation Coefficient: 0.994

Precision

Test based on Standard EN ISO 15197:2003.

A laboratory study was conducted with SensoLite Nova Test

strip using fresh sodium EDTA venous blood with a broad

range of glucose levels. Results from a single typical run of

this study, shown in the table, exhibit excellent precision

characteristics for SensoLite Nova Test strip. From all the

studies taken together, estimates of system precision were

calculated within-run precision, 3.65% between run precision,

3.42%.

Individual Use Method

Number of Reading 100 100 100 100 100

Average (mmol/l) 2.9 4 6.9 11.4 17.1

SD (mmol/l) 0.12 0.15 0.22 0.35 0.68

CV (%) 4.1 3.75 3.2 3.1 4.0

References:

N.Tietz, Fundamentals of Clinical Chemistry,

W.B.Sanders Co., 1987.

A.E.G. Cass, Biosensors: A practical approach,

IRL Press, 1990.

D. Schade, „101 Tips for Improving your blood sugar", p 4-5.

77 ELEKTRONIKA Kft.

Fehérvári u. 98.

Budapest 1116, HUNGARY

Phone: +36-1-206-1480,

Fax: +36-1-206-1481

e-mail: [email protected]

Web: www.e77.hu

SNT-9901-1 25 pcs. strips/vial

SNT-9907-1 10 pcs. strips/vial

SNT-9908-1 50 pcs. strips/vial

Symbols

In Vitro Diagnosticum

Warning!

Manufacturer

Batch No.

Date of Expiry

Temperature Range

Information inside

Biological risks

Keep away from direct sunlight!

Humidity Range

Catalog Number

98/79/EC IVD directiva

SNT-9210-1 v1.0 2007.12.

0197

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