Verification Procedures; Confirming The Limit Of Detection (Lod) - Abbott AEROSET Troubleshooting Manual

Assays/Reagents

Verification Procedures

92
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution

Confirming the Limit of Detection (LOD)

The Limit of Detection (LOD) represents the noise associated
with the analytical system in the absence of analyte. The LOD
is determined by analyzing a zero concentration sample (saline
or equivalent zero level material and adding two standard
deviations (SD) to the mean of the results. The LOD is the
mean concentration of an analyte-free sample + 2 SD, where
SD equals the pooled, within-run standard deviation of the
analyte-free sample.
Before performing the study, the following conditions must be
met:
• Maintenance procedures are up to date.
• Reagent and samples are available in sufficient quantity.
• Assays are calibrated.
• All control levels are in range.
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AEROSET System Troubleshooting Guide
94816-107—November 2004