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Difference between LOQ and LLOQ

Posted: Wed Oct 06, 2010 2:55 pm
by W Kruse
Could someone explain what the difference is in LOQ and LLOQ? Is there a difference in determination? We use LOQ at S/N >10.

THanks,
Wanda

Posted: Wed Oct 06, 2010 8:03 pm
by JGK
LLOQ is a term usially associated with Bioanalytical methods, in their guidance document http://www.labcompliance.de/documents/F ... 252fnl.pdf the FDA define it as:

Lower limit of quantification (LLOQ): The lowest amount of an analyte in a sample that can be quantitatively determined with suitable precision and accuracy.

it is not a value determined in the same way as LOD but more a determination of the practical working limits of the method in relation to acceptance criteria.

For bioanalytical methods the lowest calibration/QC STD is referred to as the LLOQ STD.