Chemcard™ Cholesterol Test - PROFESSIONAL USE
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A Complete 3 Minute Whole Blood Cholesterol Test FOR PROFESSIONAL USE ONLY INTENDED USE This test can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result. All results indicating elevated blood cholesterol levels should be verified by a quantitative cholesterol method. Clinical considerations and professional judgment should be applied to the interpretation of results by this test. SUMMARY Studies have been conducted that show the incidence of Coronary Artery Disease (CAD) rises linearly with blood cholesterol.1 Individuals with elevated blood cholesterol levels of 200 mg/dL or greater are considered at increased risk for the development of Coronary Artery Disease.2 The CHEMCARD™ Cholesterol Test is intended to identify those individuals with elevated blood cholesterol levels associated with increased risk of CAD by providing the physician with fast, accurate results and the opportunity for further testing. PRINCIPLE The CHEMCARD™ Cholesterol Test is a solid phase chemistry which employs the same principle as the enzymatic wet chemistries which are presently being used in many hospital laboratories.3 This enzymatic reaction makes use of a highly sensitive chromogen, tetramethylbenzidine, which allows for a visual determination of blood cholesterol. The CHEMCARD™ Cholesterol Test incorporates a unique cell separator as an integral part of the device. This separation device allows the use of whole blood as a specimen. Cholesterol ester Cholesterol + Oxygen Clean fingertip with alcohol and let dry. Prick finger with lancet. Discard first drop of blood. Squeeze finger to obtain a large hanging drop of blood. Gently bring the hanging drop into contact with the test area. After 3 minutes, remove entire TAB area from CHEMCARD™ and discard. Compare overall color of the Test Area with color in window on either side by sliding inner card up and down. Find closest matching color in 30 SECONDS. Note: the reactive pad will begin to fade within 3–5 minutes. Turn the card over. The cholesterol level appears in the clear windows in both mg/dL and mmol/L. Cholesterol + Fatty Acid CHOLESTEROL OXIDASE Hydrogen peroxide + Chromogen PEROXIDASE COMPOSITION Buffer Tetramethylbenzidine Cholesterol esterase EC 3.1.1.13 Cholesterol oxidase EC 1.1.3.6 Sodium cholate Peroxidase ES 1.11.1.7 Other materials required for stability and system compatibility. FOR IN-VITRO DIAGNOSTIC USE ONLY STORAGE and STABILITY CHEMCARD™ Cholesterol Tests are to be stored at room temperature, not to exceed 86°F (30°C). Refrigeration is not required. The test cards may be used until the expiration date stamped on package. Any foil packages that appear to have a broken seal should not be used for testing. Return the package to Chematics, Inc. for replacement. SPECIMEN The CHEMCARD™ is intended for use with fresh whole capillary blood collected from a fingerstick. Fingerstick samples must be obtained from free flowing capillary blood. Excessive squeezing or milking can produce somewhat lower results. MATERIALS PROVIDED Test Card MATERIALS NEEDED BUT NOT PROVIDED Alcohol or Alcohol Swab Clean Dry Tissue Watch or Other Timing System Sterile Lancet RESULTS Results are obtained by visually comparing the developed color of the Test Area with those of the sliding color standard appearing in the windows at the side of the Test Area. After a visual match is made, the card is turned over and the total cholesterol concentration value appears in the window on the back side of the card. A Test Area that appears lighter than the 150 color block should be interpreted as a cholesterol result of less than 150 mg/dL. A Test Area that appears darker than the 300+ color block should be interpreted as greater than 300 mg/dL. CALIBRATION Calibration of the CHEMCARD™ Cholesterol Test is not required. The color development for each lot of test cards is calibrated by use of precise standards during manufacturing. QUALITY CONTROL It is recommended that quality control material be analyzed at regular intervals. Upon request, a control is available from Chematics, Inc. to verify the integrity of the test cards in each new shipment and for use in routine testing. It is also recommended for use in training new test operators. Other manufacturer control materials are not recommended for use with CHEMCARD™ Cholesterol. As an alternate control material, a fresh capillary blood sample from an individual with a known cholesterol level may be used to verify the integrity of the test. For technical assistance, Chematics, Inc. Technical Service may be con

LIMITATIONS OF PROCEDURE The results of this test should not be used for instituting drug treatment in individuals with elevated cholesterol levels or altering drug treatment in individuals whose cholesterol levels are being monitored. CHEMCARD™ Cholesterol allows the specific, enzymatic determination of cholesterol and cholesterol esters. Hematocrit will cause a bias in an inverse relationship.4 For this reason plasma and serum will read high and are not recommended for use with this test. Cholesterol oxidase may exhibit some activity for certain steroids such as epiandrosterone,...