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Clinical Chemistry 30: 515-517, 1984;
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Clinical Chemistry, Vol 30, 515-517, Copyright © 1984 by American Association for Clinical Chemistry

Limits of detection and quantification, as applied to an assay for digoxin

SM Kalman, DR Clark and LE Moses

The low-range sensitivity of a drug assay in routine use is an important aspect of that assay's clinical usefulness. We define three concepts for determining low range sensitivity: LC, the detection threshold; LD, the lower limit of "virtually ensured" detection; and LQ, the limit of quantitative determination. To illustrate these concepts, we apply them to a radioimmunoassay for digoxin, and show that for standards ranging from 0.3 to 5.0 micrograms/L, the LQ is 0.35 micrograms/L (+/- 10%).


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