Thermo Scientific Phadia 100, User Manual

Page: 56 / 357

Phadia 100 - User Manual Routine Assay Run
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EliA IgG, EliA IgA, EliA IgM and EliA
Calprotectin
Reagents for EliA IgG
EliA IgG Conjugate
EliA Diluent
EliA ANA Control
EliA IgG Calibrators
EliA dsDNA Wells
In addition six individual patient samples per method are required.
Protocol for acceptance of EliA IgG, EliA IgA and EliA IgM
Below you see an example for EliA IgG. This is applicable also for EliA IgA and
EliA IgM. The reagents differ depending on selected method.
Run 1:
• Full calibration curve (0, 4, 10, 20, 100, 600 µg/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• EliA ANA Control, two levels in duplicate on EliA dsDNA Wells (define
controls according to Chapter 4, Assay Run Editing Functions)
• At least six individual patient samples in duplicate on EliA dsDNA Wells
Criteria for acceptance of Run 1:
• The instrument software accepts the curve
• The mean values for EliA ANA Control are within given range
Run 2 and 3:
• Curve control 1 (two replicates as default)
• EliA ANA Control, two level tested in duplicate on EliA dsDNA Wells.
• At least six individual patient samples (same as in the first run) in duplicate
on EliA dsDNA Wells
Criteria for acceptance of Runs 2 and 3:
• Curve control is within range, the run is accepted by the instrument software
• The mean values for EliA ANA Control are within given ranges