PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET
®
System Troubleshooting Guide 95
94816-107—November 2004
Limit of Detection for Abbott Assays Data Sheet Example
Date: 3/11/03 Analyte: ABC
Instrument: AEROSET System Serial No.: 1243
Record the values for the zero concentration sample replicates.
Calculate the limit of detection.
Comments: Confirmed limit of detection
_______________________________________________________________________________________
Technologist: (Name)
Date: 3/11/03
Reviewed by: (Name)
Date: 3/11/03
Lot Number Expiration Date
Reagent Kit 334455MB 07/07/03
Calibrators 50383 05/01/03
Replicate Value
10.05
20.05
30.03
40.04
50.02
60.06
70.03
80.02
90.10
10 0.02
A. Determine the mean of the replicates: Mean* = 0.04
B. Determine the SD of the replicates: SD = 0.02
C. Multiply the SD by 2: 2 × SD = 0.04
D. Add line A and line C: Mean + (2 × SD) = 0.08
* If the calculated mean is 울 0, enter 0 as the mean.
Data Summary Calculated Value Expected Value
Limit of Detection 0.08 0.12
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