Do we have sensitivity and specificity data for all EliA analytes?
Sensitivity and specificity data for CCP, Celikey and ANCA on EliA are available. Sometimes taken from external studies, but e.g. for ANCA we have done them internally before launch.
Some of the EliA analytes are markers of very rare diseases and are found only in a portion of patients. Obviously, for those markers it is not possible to define clinical sensitivity and specificity when developing such a test.
For those analytes a technical sensitivity and specificity was evaluated by measuring samples with defined antibody specificity such as AMLI samples, CDC samples and WHO samples.
Of course the data for technical sensitivity and specificity are not at all comparable to clinical sensitivity and specificity.
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