Thermo Scientific Phadia 100, User Manual

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Routine Assay Run Phadia 100 - User Manual
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Protocol for acceptance of ImmunoCAP Specific IgG4
Run 1:
• Full calibration curve (0, 3, 15, 35, 120, 300 µg/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• All controls, tested in duplicate
• At least six individual patient samples in duplicate
Critieria for acceptance of Run 1:
• The instrument software accepts the curve
• The mean values for the controls are within given ranges
Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• All controls, tested in duplicate
• At least six individual patient samples (same as in the first run) in duplicate
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 IgG4:
• 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.