PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
92
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Verification Procedures
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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