Am immunohistochemical (IHC) assay must undergo analytical validation before it can be used in a diagnostic capacity on a patient's specimen.
Assay: immunohistochemical assay
Whenever testing is performed, a positive and negative control is performed. Unexpected results need to be investigated before diagnosis of patient specimens.
A performance assessment should be performed after the initial studies if any of the following occur:
(1) change in fixative
(2) change in antigen retrieval method
(3) change in detection system
(4) change in tissue processing equipment
(5) change in automated testing platform
(6) change in environmental conditions (laboratory relocation, change in water source, etc.)
(7) change in reagent lot
The number of positive and negative controls is determined by the laboratory director and varies with the substantive changes that occurred. If a major change has occurred (such as change in the antibody clone), then a repeat of the initial protocol may be performed.
