TY - JOUR
T1 - Standardization of negative controls in diagnostic immunohistochemistry
T2 - Recommendations from the international ad hoc expert panel
AU - Torlakovic, Emina E
AU - Francis, Glenn
AU - Garratt, John
AU - Gilks, Blake
AU - Hyjek, Elizabeth
AU - Ibrahim, Merdol
AU - Miller, Rodney
AU - Nielsen, Søren
AU - Petcu, Eugen B
AU - Swanson, Paul E
AU - Taylor, Clive R
AU - Vyberg, Mogens
PY - 2014/4
Y1 - 2014/4
N2 - Standardization of controls, both positive and negative controls, is needed for diagnostic immunohistochemistry (dIHC). The use of IHC-negative controls, irrespective of type, although well established, is not standardized. As such, the relevance and applicability of negative controls continues to challenge both pathologists and laboratory budgets. Despite the clear theoretical notion that appropriate controls serve to demonstrate the sensitivity and specificity of the dIHC test, it remains unclear which types of positive and negative controls are applicable and/or useful in day-to-day clinical practice. There is a perceived need to provide "best practice recommendations" for the use of negative controls. This perception is driven not only by logistics and cost issues, but also by increased pressure for accurate IHC testing, especially when IHC is performed for predictive markers, the number of which is rising as personalized medicine continues to develop. Herein, an international ad hoc expert panel reviews classification of negative controls relevant to clinical practice, proposes standard terminology for negative controls, considers the total evidence of IHC specificity that is available to pathologists, and develops a set of recommendations for the use of negative controls in dIHC based on "fit-for-use" principles.
AB - Standardization of controls, both positive and negative controls, is needed for diagnostic immunohistochemistry (dIHC). The use of IHC-negative controls, irrespective of type, although well established, is not standardized. As such, the relevance and applicability of negative controls continues to challenge both pathologists and laboratory budgets. Despite the clear theoretical notion that appropriate controls serve to demonstrate the sensitivity and specificity of the dIHC test, it remains unclear which types of positive and negative controls are applicable and/or useful in day-to-day clinical practice. There is a perceived need to provide "best practice recommendations" for the use of negative controls. This perception is driven not only by logistics and cost issues, but also by increased pressure for accurate IHC testing, especially when IHC is performed for predictive markers, the number of which is rising as personalized medicine continues to develop. Herein, an international ad hoc expert panel reviews classification of negative controls relevant to clinical practice, proposes standard terminology for negative controls, considers the total evidence of IHC specificity that is available to pathologists, and develops a set of recommendations for the use of negative controls in dIHC based on "fit-for-use" principles.
U2 - 10.1097/PAI.0000000000000069
DO - 10.1097/PAI.0000000000000069
M3 - Journal article
C2 - 24714041
SN - 1541-2016
VL - 22
SP - 241
EP - 252
JO - Applied Immunohistochemistry & Molecular Morphology
JF - Applied Immunohistochemistry & Molecular Morphology
IS - 4
ER -