PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
96
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Confirming the Limit of Quantitation (LOQ)
The Limit of Quantitation (LOQ) represents the analyte
concentration corresponding to a coefficient of variation (CV)
of 20%. This is considered the functional sensitivity of an
assay.
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.
Procedure
1. Prepare the low analyte sample for each assay to be tested.
Review the reagent package insert for the LOQ. Dilute the
first or second non-zero calibrator to the approximate
concentration of the LOQ stated in the insert. For
example, the LOQ for AEROSET Carbamazepine is
0.5 µg/mL. The Level 2 calibrator (first non-zero
calibrator) contains 2.0 µg/mL of analyte. The following
dilution can be prepared:
1:4 dilution of the Level 2 calibrator, resulting in a
0.5 µg/mL sample for testing
2. Select <Database> in the Information Access Area of the
Main Display. The DATABASE screen displays.
3. Select <Order> in the right column of the screen. The
Order Samples screen displays. If this is not the first
sample ordered, select <New>.
4. Enter the following information:
• Name or SID
•C/P
•Replicates (5)
5. Select the assay(s) to be evaluated.
6. Select <Copy> in the right column of the Order Samples
screen. The Copy Order dialog window displays.
7. Enter 1 in the How Many Copies? field to request one copy
(N = 10, 2 samples × 5 replicates) then select <OK>. The
Order Samples screen displays.
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