ISAC is a semi-quantitative technology. What does it mean?
The definition of a semi-quantitative test according to CLSI IL/A20-A2 is not related to the accuracy or quality of a test results, it is related to the calibration methodology.
ImmunoCAP ISAC® sIgE 112 calibration is made against an in-house reference preparation (called control sample) and measured IgE antibody concentrations are expressed as arbitrary units; ISAC Standardized Units for IgE (ISU-E). The ImmunoCAP ISAC® sIgE 112 in-house reference preparation is calibrated against ImmunoCAP Specific IgE, which is standardized against the WHO reference preparation 75/502 for IgE.
In other words: ImmunoCAP ISAC is formally, according to CLSI IL/A20-A2, considered as "semi-quantitative" because the dose response curve used to estimate the levels of IgE antibodies is not directly calibrated to the WHO IgE reference preparation for IgE. The results for IgE antibodies, expressed in arbitrary ISAC Standardized Units for IgE (ISU-E), are proportional to the concentration of specific antibodies in test samples. The results are continuous and range from 0 to 100 ISU-E. This range approximately corresponds to a concentration range of 0 -100 kU/l IgE.
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