The College of American Pathologists has developed the first evidence-based guideline to validate all immunohistochemical (IHC) assays. The guideline, “Principles of Analytic Validation of Immunohistochemical Assays,” is available in the online edition of Archives of Pathology & Laboratory Medicine.
The new guideline outlines 14 evidence-based and expert consensus recommendations that help ensure that an IHC test accurately measures the analyte of interest and that validation is appropriate for the test’s intended use. Recommendations are also provided for verifying that an existing validated assay continues to perform as expected when there has been a change in laboratory location, test methods, or equipment.
With the guideline, laboratories can be assured they are following consistent procedures based upon recent scientific evidence and expert consensus opinion. This consistency promotes patient safety by ensuring laboratories achieve the various steps required by regulatory and accreditation agencies before performing testing on a patient specimen.
To develop the guideline, the CAP convened an expert panel of pathologists and histotechnologists to conduct a systematic review of more than 125 publications covering almost 1,500 citations in the context of open comment feedback, quality of evidence, and their own expert judgments in the field of immunohistochemistry. The CAP Pathology and Laboratory Quality Center provided the forum for the guideline development. The guideline will be updated as new scientific evidence becomes available.
“As laboratory testing moves toward personalized medicine, the new IHC validation guideline may also provide a framework for validating molecular and genomic–based assays,” says Patrick L. Fitzgibbons, MD, FCAP, lead author of the guideline, “Pathologists can take the lead by implementing the guideline in their hospitals and into their practices.” Read the guideline.