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Abstract

A method and device is described for a quality control device for immunohistochemical testing of surgical biopsies. Immunohistochemistry testing involves the use of antibodies to detect the presence of proteins that have diagnostic or prognostic importance. A cell-free moiety is covalently attached to glass microscope slides. The cell-free moiety can represent antibody contact sites to the native protein. Namely, the cell-free moiety can contain the same amino acid sequence as the epitope in the native protein to where the antibody binds. Alternatively, the cell-free moiety may not necessarily share the exact sequence as found in the native protein but they still bind to the antibody. Tissue sections derived from surgical biopsies can be mounted on the same glass slides bearing the cell-free moiety. As the immunohistochemical stain is performed on the tissue section, a similar reaction sequence occurs at the site of the glass slide where the peptide is located. At the conclusion of the immunohistochemical stain, a colored reaction product deposits at the site of the cell-free moiety. Since the immunohistochemical reaction at the cell-free moiety is largely the same as that which occurs in the tissue section, the cell-free moiety serves a quality control function. In an improvement to the device, a method is described to model formalin fixation using the peptides. This is important because surgical biopsies are routinely fixed in formalin. With this improvement, the cell-free moiety is not capable of binding to the antibody, unless antigen retrieval is performed. With this improvement, it is possible to distinguish possible sources of testing error associated with antigen retrieval, as distinguished from possible sources of error associated with the reagents or staining protocol.

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