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CHEMCARD™
GLUCOSE
Rapid One-Step
Systems Plasma Glucose Test Card
Diabetes Risk Assessment Initial Screening Test

The Chemcard™
Glucose Test is a simple, easy to use and effective
initial screening test to identify abnormally high fasting plasma glucose
(blood sugar) levels which are often a warning sign of diabetes. Chemcard™
Glucose is a 3 minute test which requires a single drop of blood obtained from a
finger prick drop of whole blood. The Chemcard™
Glucose test requires no instruments, and was shown in
clinical trials to be 94 to 99.95 percent accurate in identifying normal and
abnormal fasting plasma glucose levels. Chemcard™ Glucose requires no
instruments and is FDA 510(k) approved for both home use and in doctor's
offices. |
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INTENDED USE*
These simple, one-step professional tests can be used to quickly identify
elevated blood glucose levels associated with
increased risk of diabetes in three (3) minutes. The
CHEMCARD™ Glucose Test provides a preliminary semi-quantitative, analytical test result without the need of special equipment or training. A specially
treated test pad chemically reacts with the test whole blood sample to provide a color change that
compares with five (5)
predetermined levels of blood glucose ranging from
50 mg/dL to
150+ mg/dL.
The CHEMCARD™ Glucose Test
provides a quick and inexpensive initial risk assessment test for diabetes for
at risk individuals. Consistently high levels of fasting blood glucose levels
are an early warning sign for the onset of Diabetes. NOTE: This test is an
initial semi-quantitative screen only. Only a trained medical professional can
diagnose a condition or disease through more extensive evaluation.
BACKGROUND
Diabetes is a disease in which the body does not
produce or properly use insulin, a hormone which is needed to convert sugar,
starches and other foods into the energy needed for daily life. Diabetes is one
of the most common and costly health problems in the US, with approximately 6
percent of the US population having the disease. The American Diabetes
Association (ADA) estimates there are more than 5.4 million people in the US
alone who are not aware they have diabetes. Many of these people only become
aware they have the disease when they develop life threatening complications,
such as blindness, kidney disease, heart disease, stroke, nerve disease or
amputation. As a result, the ADA, the Centers for Disease Control (CDC), and the
National Institute of Diabetes and Kidney Diseases now recommend screening as a
necessary first step in an effort to detect diabetes at an earlier stage, before
the onset of serious complications.
Fasting Blood Glucose Levels
Less than or equal to
100 mg/dL
= NORMAL
Blood Glucose
Greater than or equal to 125
mg/dL = ABNORMAL Blood
Glucose
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Note: All results of 125 mg/dL or greater should be
repeated by a quantitative laboratory method before a diagnosis of
ABNORMAL plasma glucose is made.
The ADA recommends screening individuals having
one or more of the following diabetes risk factors, every three years:
• Family history of diabetes: Parents or siblings with
diabetes.
• Obesity: 20 percent or more overweight.
• Race/ethnicity: African American, Hispanic, Native
American, Pacific Islander.
• Age: All individuals 45 years and older.
• Individuals with hypertension (high blood pressure):
140/90 mmHg or higher.
• Individuals identified with impaired fasting glucose
level or impaired glucose tolerance.
• Individuals with HDL (good) cholesterol level at or
below 35 mg/dl (0.90 mmol/l).
• Women with a history of diabetes during pregnancy.
• Women who have delivered a baby weighing over 9 lbs.
(4kg.).
Chemcard™ Glucose was specifically developed to implement the diabetes screening
and decision level guidelines recommended by the ADA. Unlike other glucose test
methods which are intended for use in monitoring of known diabetics, Chemcard™
Glucose is designed as an initial screening tool to help identify diabetics who
are unaware they have the disease, before the onset of serious health
complications. Studies indicate that early detection of diabetes allowing
prompt, effective treatment often helps reduce the severity of, and even help
prevent some complications associated with chronic diabetic hyperglycemia.
The CHEMCARD test is
intended for use with fresh capillary blood collected from a finger prick. Finger prick
samples are a large drop of free flowing capillary blood. Excessive squeezing or
"milking"
should be avoided when obtaining samples as this can produce somewhat lower results.

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MATERIALS PROVIDED WITH
EACH TEST PROCEDURE
(KIT VERSIONS ONLY DOES NOT
APPLY TO BULK TESTS)
1
(One) Chemcard GLUCOSE Test Card
1 (One) Sterile Lancet
1 (One) Alcohol Preparation
Swab Pad
1 (One) Sterile Sheer Patch
bandage
Complete Step-by-Step Instructions |
TEST PROCEDURE
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Preparation |
Procedure |
Test
Results |
AFTER FASTING for eight
hours (overnight), Clean fingertip with an
alcohol swab and let dry. Allowing the alcohol to dry minimizes any sting from
the lancet. Prick finger with a sterile lancet. Discard the first drop of
blood. DO NOT REMOVE THE TAB AREA OF THE TEST DEVICE.
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Gently Squeeze finger to obtain a large or "hanging" drop of
blood Carefully place the drop onto the small circular test pad identified on the CHEMCARD. Wait exactly three (3) minutes for chemical reaction and development. Use a
timer.
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After 3 minutes, remove the entire Tab area from the
front of test card and discard. Compare the color in the center test pad with the colors on the slide out test card.
Match pad color to the closest color reference color.
Read the Glucose level
shown in the result box on the back of the test card.
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INTERPRETATION
OF RESULTS
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System glucose values are obtained by direct visual
comparison with the color sample slide device
and the reactive pad printed on each
test card. After development time the reactive pad will turn from blood red to
progressively darker shades of blue/green. Note: Since this is a qualitative judgment
involving color, shade and intensity, it is often helpful to get another persons
opinion of test results. Note: It is important to make the color comparison within 60 seconds as the test area will begin to fade after one (1) minute.
Each of the
five color panels on the slide
device represent a system glucose threshold range. The
lightest color compares to a level of 50 mg/dl glucose. Each successive darker panel
compares to system cholesterol levels of 75, 100,
125 and
150+ mg/dl respectively. A reactive pad that appears lighter than
the 50 color block should be interpreted as a
cholesterol result less than 50 mg/dl
glucose. Likewise, a reactive pad that appears
as dark or darker than the 150 color block should be
interpreted as greater than 150 mg/dl.
A result of 100 mg/dl glucose or less is considered a normal test. A result of
125 mg/dl or greater is considered an Abnormal test (abnormally high glucose).
Abnormal tests should be repeated after another fasting period. If subsequent
test results appear abnormal, professional medical advice should be obtained.
Additionally, if abnormal results are obtained, a follow up laboratory
Diabetes A1c blood analysis kit can be ordered
here for confirmation of abnormal results.
Related Products: BioSafe™ Diabetes A1c Laboratory Test
kit for confirmation of abnormal test results.
View CHEMCARD™
Glucose Test
Product Insert
Important: Independent reagent calibration of this cholesterol
test is not required nor is the use of any reagent controls. The color wheel on each lot of test cards is calibrated by use of precise
standards during manufacturing including extensive quality control procedures.
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ORDER
AVAILABILITY
Kit order
unit or complete kit contains three (3)
or ten (10) individual test cards with
accessories as noted above. Complete kits are available for 3
and 10 test procedures. A Professional Physician pack of 24 bulk test cards
only (no accessories) is also available as well as a master
distributor case of 288 bulk test cards (12 boxes of 24 tests, no accessories).
Description |
Packaging |
Sale
Unit |
Cost |
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CHEMCARD™
Rapid Blood GLUCOSE Test
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Sealed Poly Kit
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Three (3) Test Kit
complete |
$14.90
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Ten (10) Test Kit
complete |
$39.00
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Physicians
Pack Boxed
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24
Bulk Test Cards Only
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$55.00
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Master Distribution
Case |
288
Bulk
Test Cards Only
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$600.00 |
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*If the
order buttons are absent or inoperable, please use the
pricing overview page to order. |
View CHEMCARD Glucose Test Product Insert
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Professional EZ-Lance®
Auto-Lance spring loaded lancets available separately:
Lancets |

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