Thermo Scientific Phadia 100, User Manual

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Phadia 100 - User Manual Monthly Calibration
12-3501-20/12 Page 7.3
7
Acceptance of Calibration Curve Assay Runs
In Phadia 100 numerous functions are checked before the assay is judged by the
software as accepted or not. The instrument will automatically after each assay
self-check important functions; the assay blank and signal of calibration
controls, and the curve fitting. If all these functions have performed within the
specified limits, the assay is recommended to be accepted by the operator.
ImmunoCAP Specific IgE, ImmunoCAP Total IgE, ImmunoCAP Specific IgA,
ImmunoCAP Specific IgG and ImmunoCAP Specific IgG4 use a 5-parameter
logistic function to estimate the calibration curve while ECP, EliA IgA, EliA IgG,
EliA IgM. EliA Calprotectin and Tryptase use a 4-parameter logistic function.
These functions, also called Rodbard, normally use many iterations. The
parameters of the function are iteratively estimated until a good curvefit is
obtained.
Calibration Curve Assay and Interpretation of obtained Calibrator
Point Values
• If all replicates of the lowest calibrator point (second lowest in EliA IgG, EliA
IgA and Elia IgM) are discarded - The calibration curve will not be evaluated
and not set as active.
• One replicate is discarded - The calibration curve will be evaluated and set
as active.
• Two or three replicates are discarded - The calibration curve will be
evaluated but not set as active.
• More than three replicates are discarded - The calibration curve will not be
evaluated and not set as active.
• If the number of iterations exceeds 150 the calculation stops - The calibra-
tion curve is evaluated and the results will be calculated.
RU
kU/l
Upper RU Limit
Ideal curve
Lower RU Limit