A novel assessment of the quality of immunohistostaining overcomes the limitations of current methods.

Quality assurance has become an integral part of surgical pathology. Despite the development of interdisciplinary quality systems, however, the means for objective analysis in surgical pathology are limited. Immunohistostaining is a multi-factorial procedure that depends on the quality of reagents and antibodies employed in the process and on technical methodology. In the present study, we aim to establish a straightforward procedure for objective quality evaluation of the components involved in immunohistostaining. The quality of two of these components, the primary antibody and the automated staining device, was assessed by employing each component from two different sources, one serving as the test substance and the second as the reference. Assessment was performed by at least two pathologists in a blinded fashion using pre-established quality criteria and scores. The quality analysis of two automated devices revealed a significant difference between the reference and tested devices (3.5+/-1.7 and 4.2+/-1.5, respectively, P>0.05), while the analysis of two selected antibodies did not reveal any statistical difference. The described method provided objective quality assessment of selected components affecting immunohistostaining by elaborating numeric values that enabled statistical analysis. This approach is applicable to any given component in various surgical pathology procedures.