Elite Blood Glucose Test Strips and Code Strip
For Use with Glucometer Elite" Blood Glucose Meter To Test For
Glucose in Whole Blood
Glucometer Elite Blood Glucose Test Strips quantitatively measure
glucose in whole blood and are designed for use with the Glucometer
Elite Blood Glucose Meter only. When the tip of the Test Strip touches
a drop of blood, the strip fills automatically through simple capillary
action. The blood is drawn into a reaction chamber and a reading is
displayed on the meter. Only a small amount of blood is needed and no
wiping or blotting is required. The test provides a quantitative measurement
of glucose from 1.1 to 33.3 mmol/L (20 to 600 mg/dL).
Elite Code Strip is provided with each package of Test Strips. Each
Code Strip has a specific Code Number (Function Number). When the Code
Strip is inserted, the meter is automatically calibrated. When you calibrate,
you set the electronic system in the meter to match the reactivity of
that specific package of Test Strips. By setting the electronic system,
you match the meter system to the Test Strip to give accurate test results.
Each package of Test Strips contains its own Code Strip. The Code Strip
is inserted into the Test Strip slot and when the "F-#" is
displayed, coding (calibration) is complete. It is important that the
Function Number set in the meter matches the Code Strip number for the
package of Test Strips in use.
NOTE: # indicates a number between 0 and 12.
Code Strip Procedure:
Materials required: Glucometer Elite Meter and Code Strip
- Insert Code
Strip fully into the Test Strip slot. (Two beeps will sound and an
F-# will appear on the display)
- Remove the
Code Strip. Your meter is now ready for blood glucose or control testing.
Test Strip Procedure:
Materials required: Glucometer Elite Meter and Test Strip
- Insert the
Test Strip into the meter. (The F-Number that flashes on the display
should match the F-Number on the foil pouch.)
- Touch and hold
the test end of the Test Strip to a drop of blood until after the
See your Glucometer
Elite Blood Glucose Meter User Guide for detailed illustrated directions
for both procedures.
29.1% w/w glucose oxidase (Aspergillus niger, 20 U/mg)
32.0% w/w potassium ferricyanide
38.9% w/w nonreactive ingredients
- For in vitro
diagnostic use (external use only).
- The Glucometer
Elite Blood Glucose Meter has been optimized for use with Glucometer
Elite Test Strips. The performance characteristics of the Meter may
not be valid for any other brand of Test Strips. The use of other
Test Strips may cause erroneous results Bayer Corporation does not
warrant the use of the Glucometer Elite Blood Glucose Meter with any
Test Strip other than Glucometer Elite Test Strips.
Healthcare professionals or persons using this system on multiple
patients should be aware that all products or objects that come in
contact with human blood, even after cleaning, should be handled as
if capable of transmitting viral diseases. For further information,
see the Glucometer Elite User Guide.*
- Do not ingest
desiccant bead sealed in foil packet.
- Altitudes up
to 8800 ft. do not significantly affect Glucometer Elite test results.
Do not use Test Strips after expiry date.
Strips may give false test results if used beyond the expiry date.
To keep Test
Strips fresh, follow these recommendations carefully:
- Store at temperatures
between 59º-86ºF (15º-30ºC).
- Store away from
- Allow time
for Meter and/or Test Strips to come to room temperature before use.
- Use the Test
Strip immediately after opening the foil packet.
- Either end
of the Test Strip may be held before inserting into Meter without
OF THE PROCEDURE
The Glucometer Elite blood glucose test is based on measurement
of electrical potential caused by the reaction of glucose with the reagents
on the electrode of the strip. The blood sample is drawn into the tip
of the Test Strip through capillary action. Glucose in the sample reacts
with glucose oxidase and potassium ferricyanide. Electrons are generated
producing a current which is proportional to the glucose in the sample.
After a specific reaction time for your meter, the glucose concentration
in the sample is displayed.
Sufficient blood to perform the test may be obtained from the fingertip.
Preparation of the puncture site is important. The puncture site should
be cleaned with mild soap and warm water - then rinsed and dried thoroughly
before testing. If alcohol is used to wipe the puncture site, make sure
the site is completely dry before pricking the finger. If desired, a
venous whole blood sample may be used. A venous whole blood sample usually
reads higher than a capillary sample from the same person (approximately
7% higher on average with normal glucose samples) due to the unique
electrochemical properties of the Glucometer Elite Test Strip. Use venous
blood within 30 minutes after drawing. Comrnon anticoagulants (potassium
oxalate, heparin and EDTA) may be used.
To check performance of the meter, Test Strip and your testing technique
(applying sample to Test Strip). The meter, Test Strip and your testing
technique are acceptable if the Control Test result falls within the
specific control range listed on the end flap of your Glucometer Elite
Test Strip carton.
IMPORTANT: Because Control Ranges can change for each new lot
of Test Strips, always use the Control Ranges on the end flap of your
current carton of Test Strips.
HOW: Run a Control Test by following the illustrated
Control Test directions in the Glucometer Elite User Guide.
WHEN: Any time you want to check the performance of your meter,
Test Strip or testing technique.
IMPORTANT: Performance is assured only when the Control Test result
falls within the specific range listed on the end flap of your Glucometer
Elite Test Strip carton. Bayer recommends that individuals run a Control
Test and consult with their physician or healthcare professional before
adjusting medication based an Glucometer Elite test results. In hospital
use, follow the approved directives of your institution.
Test results are displayed in the meter display window in either
milligrams of glucose per decaliter (mg/dL) or millimoles of glucose
per liter (mmol/L). No calculation is necessary. The mmol/L results
will always include a decimal point; mg/dL results do not include a
When Test Results
are Questionable or Inconsistent:
- Be sure the
drop of blood completely filled the tip of the Test Strip.
- Confirm that
strips are within the expiry date.
- Be sure you
have calibrated your meter by setting the correct Function Number
(i.e., the Code Strip Number for the package of Test Strips in use).
- Check meter
performance using Glucometer Elite Check Strip.
- Check meter
and strip performance using Glucometer Elite Controls.
Whole Blood Methods: Note that glucose concentrations drop rapidly
due to glycolysis (approximately 7% per hour).** For test result comparison,
compare with other whole blood methods. Because glucose concentrations
change rapidly (within minutes), this comparison must be done simultaneously
from the same sample.
OF THE PROCEDURE
- Fluoride - Do not use fiuoride as a preservative for blood
- lodoacetic acid - Do not use iodoacetic acid as a preservative
for blood specimens.
- ARTERIAL SPECIMEN:
Arterial specimens with P02 of >200 mmHg had a small bias (average
of -6%) on the Glucometer Elite in comparison to the laboratory method
glucose results. The reference range for arterial P02 is 80 to I 1
0 mmHg (11.04 to 14.36 kPa).
- NEONATAL USE:
The Glucometer Elite XL System is the only Glucometer Elite System
qualified for neonatal use. It is intended for monitoring treatment
of hypoglycemia in neonates. The Glucometer Elite XL System is not
intended for diagnosis of neonates for hypoglycemia. Do not use any
other Glucometer Elite Blood Glucose Meter for neonatal testing.
Reducing substances such as ascorbic acid and uric acid at normal
blood concentrations do not significantly affect Glucometer Elite
blood glucose test results.
At normal glucose levels, Glucometer Elite Test Strip results are
not significantly affected by hematocrits in the range of 20% to 60%.
At glucose levels above 300 mg/dL (1 6.7 mmol/L), hematocrit levels
above 55% will cause lowered results. For Neonatal Use: At
glucose levels between 20 mg/dL (1.1 mmul/L) and 120 mg/dL (6.7 mmol/L),
Glucometer Elite XL results are not significantly affected by hematocrit
levels in the range of 20% to 70%.
- LIPAEMIC SPECIMEN:
Cholesterol up to 13.0 mmol/L (500 mg/dL) or triglycerides up to 33.9
mmol/L (3000 mg/dL) do not significantly affect the results. Glucose
values however, in specimens beyond these levels should be interpreted
(Bayer advises against); Capillary (fingerstick) blood glucose
testing may not be clinically appropriate when peripheral blood flow
is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia
and occurrence of severe dehydration are examples of clinical conditions
which may adversely affect the measurement of glucose in peripheral
See your Glucometer Elite User Guide for the availability of accessory
Covered by US Patents: 5,120,420 and 5,320,732, and foreign equivalents.
*. Protection of Laboratory Workers from Instrument Biohazards and Infectious
Disease Transmitted by Blood, Body Fluids, and Tissue; Approved Guideline.
NCCLS document M29-A (ISBN 1-56238-339-6). NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 1997.
**. Tietz N.: Fundamentals of Clinical Chemistry, 3rd Ed., W B. Saunders
Co., Philadelphia, PA, 1987, p. 427,
S.. Jaker MA, Chorost Ml, Reddy S.: Fingerstick Glucose Determination
in Shock. Annals of Internal Medicine, 1991, 114:1020-24.