Whole-blood test for total cholesterol by a self-metering, self-timing disposable device with built-in quality control.

A whole-blood test for total cholesterol has been developed that is performed in a low-cost disposable flow device without user intervention (after sample addition). The device meters the sample, separates plasma from erythrocytes, and precisely times plasma flow into various reagent compartments, including a quality-assurance chamber. Test results are displayed as a well-defined and easily readable color bar. A quality-control window attests to the integrity of the test components. Here, we describe the assembly and individual functions of the device and report its performance characteristics. Precision and accuracy studies in four clinical studies at independent locations yielded total imprecision of <5% and an average bias of 1.35% vs the Abell-Kendall method.