Cholestron (Lifestream Technologies, Post Falls, ID) is a hand-held device that measures cholesterol. It is about the size of a palmtop computer and can screen a patient's overall cholesterol level with 1 drop of blood within 3 minutes. It was cleared by the U.S. Food and Drug Administration on October 5, 1998, and is manufactured by Lifestream Technologies Inc. Recommended conservative treatments for hypertension and hyperlipidemia include changes in dietary habits, increase in physical activity, and if necessary, drug therapy. There are no prospective studies demonstrating that home monitoring of cholesterol improves clinical outcomes compared to periodic testing performed in the clinic.

Molecularly Imprinted Membrane Modified Gel Colorimetric Device

Zhang et al (2022) noted that simple and disposable monitoring of blood is usually the best solution for early clinical diagnosis and home self-inspection of the chronic patients. These researchers described for the very first time a simple point-of-care (POC) device that utilizes molecularly imprinted membrane modified gel colorimetric device (MIMGCD) for whole blood cholesterol colorimetric detection. The principle of this device relies on molecularly imprinted membranes for specifically separating cholesterol from whole blood firstly, followed by the use of the gold bipyramids (GBPs) agarose gel system, which reacts with the cholesterol oxidation to product hydrogen peroxide (H2O2), and the cholesterol will then be quantified based on the color change. Under optimal conditions, the analytical performance of the proposed device yielded a linear range of 315.8 to 6,000.0 μM and detection limit of 94.7 μM with 6.89 % relative standard deviation (RSD) for cholesterol, which could meet the needs of the detection of normal cholesterol content in the human body. Compared with the traditional whole blood detection methods, no complex sample preparation steps or precision instruments are needed, endowing MIMGCD with the merits of easy to operate and low-cost. Furthermore, the multi-color variation of GBPs in the device allows a colorimetric card-like detection mechanism, which could be used for home self-inspection. Th authors concluded that this device has the potential to be used in clinical and home POC testing application for whole blood biomolecule analysis; thus, facilitating the whole blood screening and long-term monitoring in non-specialized laboratory infra-structure.

Scope of Policy

This Clinical Policy Bulletin addresses home cholesterol monitors.

Experimental and Investigational

Aetna considers cholesterol monitors for home use (e.g., Cholestron cholesterol monitor, and molecularly imprinted membrane modified gel colorimetric device) experimental and investigational because effective treatment of elevated cholesterol levels does not require daily blood testing. Thus, the value of home monitoring over periodic laboratory testing has not been established.