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.

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.

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.

TEST PROCEDURE

INTERPRETATION OF RESULTS

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.

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
CHEMCARD™ Rapid Blood GLUCOSE Test	Sealed Poly Kit	Three (3) Test Kit complete	$14.90
		Ten (10) Test Kit complete	$39.00
	Physicians Pack Boxed	24 Bulk Test Cards Only	$55.00
	Master Distribution Case	288 Bulk Test Cards Only	$600.00
*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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