PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET
®
System Troubleshooting Guide 99
94816-107—November 2004
Limit of Quantitation for Abbott Assays Data Sheet Example
Date: 3/11/03 Analyte: ABC
Instrument: AEROSET System Serial No.: 1243
Record the values for the low analyte sample replicates.
Calculate the limit of quantitation.
Comments: Confirmed limit of quantitation
_______________________________________________________________________________________
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
10.25
20.25
30.25
40.23
50.20
60.26
70.24
80.35
90.35
10 0.25
A. Determine the mean of the replicates: Mean = 0.26
B. Determine the SD of the replicates: SD = 0.0481
C. Determine the %CV of the sample: %CV = 18.5
Data Summary Calculated Value Expected Value
Limit of Quantitation 18.5% 20.0%
SD
Mean
× 100%CV =