Garbage in, garbage out: a critical evaluation of strategies used for validation of immunohistochemical biomarkers.

O'Hurley G, Sjöstedt E, Rahman A, Li B, Kampf C, Pontén F, Gallagher WM, Lindskog C

Mol Oncol 8 (4) 783-798 [2014-06-00; online 2014-04-15]

The use of immunohistochemistry (IHC) in clinical cohorts is of paramount importance in determining the utility of a biomarker in clinical practice. A major bottleneck in translating a biomarker from bench-to-bedside is the lack of well characterized, specific antibodies suitable for IHC. Despite the widespread use of IHC as a biomarker validation tool, no universally accepted standardization guidelines have been developed to determine the applicability of particular antibodies for IHC prior to its use. In this review, we discuss the technical challenges faced by the use of immunohistochemical biomarkers and rigorously explore classical and emerging antibody validation technologies. Based on our review of these technologies, we provide strict criteria for the pragmatic validation of antibodies for use in immunohistochemical assays.

Tissue Profiling

QC bibliography QC xrefs

PubMed 24725481

DOI 10.1016/j.molonc.2014.03.008

Crossref 10.1016/j.molonc.2014.03.008

S1574-7891(14)00056-8