Thermo Scientific Phadia 100, User Manual

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Phadia 100 - User Manual Routine Assay Run
12-3501-20/12 Page 2.23
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 the controls are within given ranges
Criteria for total acceptance of ImmunoCAP Specific IgG:
• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 8% for controls and
patient samples
• Total CV (%) for controls and positive patient samples are < 12%
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 Specific IgG4
Reagents for ImmunoCAP Specific IgG4
ImmunoCAP Specific IgG4
IgA/IgG Calibrator ImmunoCAP
ImmunoCAP IgG4 Calibrators
ImmunoCAP Specific IgG4 Curve Controls
ImmunoCAP i1
ImmunoCAP Specific IgG Control LMH
ImmunoCAP Specific IgG/IgG4 Control L
ImmunoCAP Specific IgG/IgG4 i1 Control H