Validation of liquid chromatography mass spectrometry (LC-MS) methods
9. LoD and LoQ
This section addresses the performance parameters that are related to the ability of the method to detect, identify and quantify low analyte levels in samples:
- Limit of detection () (also called detection limit) – the smallest amount or concentration of the analyte in the test sample that can be reliably distinguished from zero [].
- Decision limit (CCα) – the concentration level, as determined by the method, at which there is a probability α (usually defined as 0.05 or 5%) that a blank sample will give a signal at this level or higher.
- Detection capability (CCβ) – the concentration level of the analyte in the sample at which there is a probability β (again usually defined as 0.05 or 5%) that the method will give a result lower than CCα, meaning that the analyte will be declared as undetected.
- Limit of quantitation () – the lowest concentration of the analyte that can be determined with an acceptable and .
9.1. Definitions and important aspects
9.2. Decision limit and Detection capability
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