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The ActiMed ENA C-T™ Total Cholesterol Test is a non-instrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for physician directed use (PDU) by the patient for screening and monitoring cholesterol. In a PDU monitoring application, the patient's physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy. In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper interpretation of results and limitations of the test. The physician directed use version of the ENA.C.T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

The ActiMed ENA-C-T™ Total Cholesterol Test is a noninstrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is based on stable, dry chemistry reagents embedded in a flow device with a factory calibrated scale. The device provides a direct visual read-out of test results. It has built-in controls to indicate that a sufficient volume of whole blood has been added as sample, to verify that the reagents are functioning, and to confirm when the test has been completed. The test device is self-actuating, requiring neither timing nor handling between addition of the sample and reading the result.

The ActiMed ENA C.T™ Total Cholesterol Test is a non-instrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for professional use in settings such as clinical laboratories and physician office laboratories (POLs) to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

The ENA-C-T™ Total Cholesterol Test is based on stable, dry chemistry reagents embedded in a flow device with a factory calibrated scale. The device provides a direct visual read-out of test results. It has built-in controls to indicate that a sufficient volume of whole blood has been added as sample, to verify that the reagents are functioning, and to confirm when the test has been completed. The test device is self-actuating, requiring neither timing nor handling between addition of the sample and reading the result. The ENA.C.T™ Total Cholesterol Test starts when a sufficient amount of whole blood has been introduced into the sample well. A self-actuating siphon, in turn, transfers the blood to an absorbent pad located immediately below the "START" window. The blood saturated pad shows through the clear window as a red indicator, signaling that enough sample has been added and that the analytical process has been initiated. The absorbent pad and a second filter separate red cells from plasma. The plasma subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the plasma to permit completion of the enzymatic reactions. Subsequently, the plasma flows into the measurement zone which acts as a capillary. In this zone, colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer. The hydrogen peroxide converted from cholesterol in the plasma converts the colorless dye layer into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the sample. The bar extends until a precise amount of plasma has completely filled the measurement zone and "END/QA" draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the plasma react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. The entire process typically requires 12 to 15 minutes. The color bar formed is stable and may be read at any time within 48 hours.

ENA C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA-C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA-C-T™ Total Cholesterol Test is an instrumentfree enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).

The ENA·C·T™ Assayed Total Cholesterol Controls are ready to use polymer solutions containing cholesterol from non-human (bovine) plasma. There are two levels of control included with each set: Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL). The controls are intended for exclusive use with the ENA·C·T™ Total Cholesterol Test. The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample. Sufficient volume of the control is added to the ENA C TM Total Cholesterol Test device in the sample well. A self-actuating siphon, in turn, transfers the control to an absorbent pad located immediately below the "START" window. The control-saturated pad shows through the clear window as a yellow indicator, signaling that enough volume has been added and that the analytical process has been initiated. The control solution subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the control solution to permit completion of the enzymatic reactions. Subsequently, the control solution flows into the measurement zone where colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer. The hydrogen peroxide generated from the cholesterol in the control solution converts the colorless dyes into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the control. The bar grows until a precise amount of solution has completely filled the measurement zone and "End/Q. A." draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the solution react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. Results outside the linear measurement range of the ENA·C·T™ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and 360 mg/dL. The color formed is stable and may be read at any time within 48 hours.