Thermo Scientific Phadia 100, User Manual

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Phadia 100 - User Manual Routine Assay Run
12-3501-20/12 Page 2.19
2
3
4
5
6
2
13
Criteria for acceptance of Runs 2 and 3:
• Curve controls are within range, the run is accepted by the instrument
software
• The mean values for ImmunoCAP Specific IgE Control are within given
ranges
• ImmunoCAP Specific IgE Negative Control is negative for all replicates
Criteria for total acceptance of ImmunoCAP Specific IgE:
• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 6% for ImmunoCAP
Specific IgE Control and patient samples
• Total CV (%) for ImmunoCAP Specific IgE Control and patient samples are
< 10%
Printouts of laboratory reports and patient reports can be done.
Calculate the CV as described in Calculation of CV % values.
If all the criteria for total acceptance are fulfilled, results can be used for clinical
routine.
When method is accepted, remember to set replicate to 1 as default for the
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument's performance, please follow instructions
in chapter 11, Maintenance.
ImmunoCAP Total IgE
Reagents for ImmunoCAP Total IgE
ImmunoCAP Total IgE
ImmunoCAP Total IgE Calibrators
ImmunoCAP Total IgE Control LMH
Protocol for acceptance of ImmunoCAP Total IgE
Run 1:
• Full calibration curve (2, 10, 50, 200, 1000, 5000 kU IgE/l, in duplicates -
this is set as default in the software when a calibration curve is requested)
• ImmunoCAP Total IgE Controls, three levels in duplicate (define controls
according to Chapter 4, Assay Run Editing Functions)
• At least six individual patient samples in duplicate