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