biostudies-literatureVani KNCATS NIH HHSNCI NIH HHS463-477https://www.ebi.ac.uk/biostudies/studies/S-EPMC5533270biostudies-literatureUnknown65(8)Clinical Immunohistochemistry (IHC) laboratories face unique challenges in performing accurate and reproducible immunostains. Among these challenges is the use of homemade controls derived from pathological discard samples. Such positive controls have an unknown number of analyte molecules per cell (epitope density). It is unclear how the lack of defined analyte concentrations affects performance of the control. To address this question, we prepared positive IHC controls ( IHControls) for human epidermal growth factor receptor type II (HER-2), estrogen receptor (ER), or progesterone receptor (PR) with well-defined, homogeneous, and reproducible analyte concentrations. Using the IHControls, we examined the effect of analyte concentration on IHC control sensitivity. IHControls and conventionThe journal of histochemistry and cytochemistry : official journal of the Histochemistry SocietyThe Importance of Epitope Density in Selecting a Sensitive Positive IHC Control.PMC5533270UL1 TR001064R44 CA183203R44 CA213476Balasubramanian AGoldsmith JDPilichowska MSompuram SRVani KNoubary FChang KGBogen SASchaedle AKNaber SfalseThe Importance of Epitope Density in Selecting a Sensitive Positive IHC Control.Clinical Immunohistochemistry (IHC) laboratories face unique challenges in performing accurate and reproducible immunostains. Among these challenges is the use of homemade controls derived from pathological discard samples. Such positive controls have an unknown number of analyte molecules per cell (epitope density). It is unclear how the lack of defined analyte concentrations affects performance of the control. To address this question, we prepared positive IHC controls ( IHControls) for human epidermal growth factor receptor type II (HER-2), estrogen receptor (ER), or progesterone receptor (PR) with well-defined, homogeneous, and reproducible analyte concentrations. Using the IHControls, we examined the effect of analyte concentration on IHC control sensitivity. IHControls and convention2017-01-01T00:00:00Z2017 Aug2025-04-26T08:59:00.175Z2019-03-26T23:48:34ZS-EPMC55332702866522910.1369/0022155417714208