The Cholesterol Complete Test (CHOL/HDL/LDL (calculated) is intended for use as an onsite in-vitro diagnostic for the semi-quantitative determination of Cholesterol and High-Density Lipoprotein (HDL) in whole blood. The test also allows for the approximation of Low-Density Lipoprotein (LDL) through a simple calculation. The Cholesterol Complete Test is used to screen for elevated cholesterol as a risk factor in coronary artery disease. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test provides preliminary analytical results only. All results indicating elevated blood cholesterol levels should be verified by a confirmatory method. Clinical considerations and professional judgment should be applied to the interpretation of results from this preliminary test device. WATCH DEMO
BACKGROUND TEST DISCUSSION
The cholesterol in human blood consists of HDL
Cholesterol (often called “good cholesterol”) and LDL Cholesterol (often called
“bad cholesterol”). Risk of heart disease is related to the HDL level, total
cholesterol level (HDL plus LDL), and other risk factors. The National
Cholesterol Education Program guidelines state that a low level of HDL (“good”)
cholesterol is associated with an increased risk of heart disease.
LDL = Total Cholesterol minus (-) HDL*
When Triglycerides are elevated, the LDL level may
be different than the above calculation.
*Note: Assumes normal triglycerides level. All results of 200 mg/dL or greater should be repeated by a quantitative laboratory method before a diagnosis of hypercholesterolemia is made.
The Cholesterol Complete Test device includes test strips that are treated with
special chromatic chemical reagents. A whole blood sample is absorbed on a
receiving pad on the back of a test strip. The blood sample absorbs through to
the front of a test strip and reacts with the reagents. The reaction area
produces a color change that can be correlated to the cholesterol concentration
in the blood sample by comparison with a supplied color chart imprinted on the
test device. The test device incorporates a solid phase
chemistry that employs the same principle as the enzymatic wet chemistries which are
presently being used in many hospital laboratories. This enzymatic reaction
makes use of a highly sensitive chromogen, tetramethylbenzidine, which allows for a visual
determination of blood cholesterol. The test incorporates a unique cell separator as an
integral part of the device. This separation device allows the use of whole blood as a
The CHOLESTEROL COMPLETE 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.
For a detailed explanation of the entire test procedure see the Product Instruction Sheet (.PDF). For a video of the complete test procedure see WATCH DEMO Simply, the finger is pricked with the included lancet to obtain a blood sample. Blood is then drawn up into the two specially metered capillary pipettes provided. Blood samples in the pipettes are then placed on the two absorbent test disks on the back of the test device, The test disks will change color based on the Total and HDL cholesterol levels detected in the blood sample. After 3 minutes and before 5 minutes, the color change is then visually compared to the color chart on the test device to determine the Total and HDL Cholesterol result. LDL cholesterol is then calculated by subtracting the HDL result from the Total Cholesterol result.
The Cholesterol Complete (CHOL/HDL/LDL(calculated) Test is retail boxed. Each boxed kit contains all the components (noted above) to perform one complete Total, HDL and calculated LDL cholesterol test. Instructions must be followed precisely. For proper use watch the DEMO Kits are available in sales units of 1,3,6,12,24, 48 and 100 kits. For special quotations of 250 kits or more contact Customer Service.