scope:

NCCLS document EP17 specifies recommendations for determining the lower limit of detection of clinical laboratory methods, for verifying claimed limits, and for the proper use and interpretation of the limits. It also provides guidance for determining lower limits of quantitation based on a laboratory's goals for performance at low-levels. EP17 may be applied to all measurement procedures (even if the reported result is qualitative), most notably those for which the medical decision level is low (i.e., approaching zero).

The intended users of this guideline are clinical laboratory supervisors and manufacturers of in vitro diagnostic tests.