1.5 Detection limit

Detection limit is defined as the Capability of Detection according to ISO11843-Part 1 and reflects the minimum level that is clearly distinguishable from Calibrator 0. Capability of Detection should be seen as a method of validation, rather than the lowest concentration that can be measured. Concentrations of samples with absorbance below Calibrator 1 should not be calculated, but rather expressed as less or equal to (≤) the concentration indicated on the vial for Calibrator 1.

Since there are a variety of methods for determining the Capability of Detection, the methods used should be known when comparing the Capability of Detection between assays. ISO11843-Part 4 describes one method for the determination of the Capability of Detection.

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