Calibration
Calibration Curve
Theory of Operations
IMMAGE 800 Operations Manual A11403
Page 3-12
September 2016
Calibration
Calibration Curve
The calibration curve for each lot of reagent is determined by Beckman Coulter, Inc.
In general, the calibration curve is formed from eight to twelve standards of known
analyte concentrations, with approximately thirty points per standard, tested on
multiple systems. The calibration curve parameters are coded onto a lot specific
reagent bar code card. When a reagent bar code card is read, the curve parameter
information is transferred and stored by the system.
System Calibration
System calibration is accomplished by testing a single analyte concentration which is
contained in a specific calibrator. To ensure a valid calibration, the system requires
that the rate response of two replicates obtained during calibration is reproduced
within a predefined percentage. The averaged rate of the two replicates is used to
establish a calibration scale factor based on the assigned calibrator target value. The
calibration scale factor is used to adjust the measured rate response to equal the
theoretical response.
Protein Calibration Curve
When the antibody concentration is constant, the rate response will increase as antigen
concentration increases. The maximum rate response occurs when the antibody and
antigen are in optimal proportions. As antigen concentration increases further, the rate
response will then progressively decrease. The regions at lower and higher antigen
concentration are called antibody excess and antigen excess, respectively.
Drug Calibration Curve
When the concentration of conjugate and specific antibody are constant, the rate
response will decrease as drug (hapten) concentration increases. The maximum rate
response occurs when the drug is absent, and the maximum amount of antibody is
available to react with the conjugate.
