Thermo Scientific Phadia 100, User Manual

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Phadia 100 - User Manual Routine Assay Run
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Protocol for acceptance of ImmunoCAP ECP and ImmunoCAP
Tryptase
Below you see an example for ImmunoCAP ECP. This is applicable also for
ImmunoCAP Tryptase. The reagents differ depending on selected method.
Run 1:
• Full calibration curve (2, 5, 15, 100, 200 µg ECP/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• ImmunoCAP ECP Control in four replicates (define controls according to
Chapter 4, Assay Run Editing Functions)
• At least six individual patient samples in duplicate
Criteria for acceptance of Run 1:
• The instrument software accepts the curve
• The mean value for ImmunoCAP ECP Control is within given range
Run 2 and 3:
• Curve control 1 (two replicates, as default)
• ImmunoCAP ECP Control in four replicates
• At least six individual patient samples in duplicate
Criteria for acceptance of Runs 2 and 3:
• Curve control is within range, the run is accepted by the instrument software
• The mean value for ImmunoCAP ECP Control is within given range
Criteria for total acceptance of ImmunoCAP ECP:
• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficient of variation (CV) within assay runs are < 6% for
ImmunoCAP ECP Control and patient samples
• Total CV (%) for ImmunoCAP ECP 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 in good shape, please follow instructions in
chapter 11, Maintenance.