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Clinical Chemistry 36: 1591-1597, 1990;
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Clinical Chemistry, Vol 36, 1591-1597, Copyright © 1990 by American Association for Clinical Chemistry

A noninstrumented quantitative test system and its application for determining cholesterol concentration in whole blood

MP Allen, A DeLizza, U Ramel, H Jeong and P Singh
ChemTrak, Inc., Sunnyvale, CA 94086.

A novel noninstrumented technology has been developed for quantifying analytes of clinical interest in biological fluids. Application of this technology is exemplified by the development of a quantitative cholesterol test with performance equivalent to state-of-the-art instrumented methods. The assay chemistry combines two separate processes located in different areas of a test strip: enzymatic action on serum cholesterol to produce hydrogen peroxide (5 x 10 mm enzyme reagent pad) and quantification of the hydrogen peroxide (5 x 70 mm measurement region). Color bands are formed in the measurement area through the use of a redox-coupled indicator system. The height of the color band on the strip is directly proportional to the sample cholesterol concentration. A one-step cassette contains all components necessary to run the test and includes blood filtration and automatic sample measurement, so that unmeasured finger-stick whole-blood specimens can be analyzed by the non-technically trained user. The test is complete in less than 15 min, is read visually like a thermometer, and gives results that are in excellent correlation with established instrumented methods.


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W. T. Law, S. Doshi, J. McGeehan, S. McGeehan, D. Gibboni, Y. Nikolioukine, R. Keane, J. Zheng, J. Rao, and G. Ertingshausen
Whole-blood test for total cholesterol by a self-metering, self-timing disposable device with built-in quality control
Clin. Chem., February 1, 1997; 43(2): 384 - 389.
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Copyright © 1990 by the American Association for Clinical Chemistry.