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Breast (ER, PGR and HER2) Dynamic Range Analyte Control

Our multi-purpose Breast Analyte ControlDR contains five cell lines that demonstrate a Dynamic Range of expression for ER, PR and Her-2. Ideal for use as a same slide control in immunohistochemistry (IHC) to fully demonstrate the sensitivity in your assay and provide ultimate confidence in the result. Available now, please contact sales@histocyte.com or visit one of our distributors.

[HCL016]: Breast Analyte ControlDR (2 unstained slides)
[HCL017]: Breast Analyte ControlDR (5 unstained slides)
[HCL018]: Breast Analyte ControlDR (1 cell microarray block)

Cell Line 1: ER, PR and Her2 expression
ER, PR and Her2 expression

Cell Line 2: ER, PR and Her2 expression
ER, PR and Her2 expression

Cell Line 3: ER, PR and Her2 expression
ER, PR and Her2 expression

Cell Line 4: ER, PR and Her2 expression
ER, PR and Her2 expression

Cell Line 5: ER, PR and Her2 expression
ER, PR and Her2 expression. Universal Negative.

Introduction
Suitable tissue able to reflect different expression levels of Estrogen Receptor (ER), Progesterone Receptor (PR) and Human Epidermal growth Factor Receptor 2 (Her2) is time consuming and sometimes difficult to obtain. HistoCyte Laboratories Ltd have been able to develop a product that is suitable for demonstrating the relative sensitivity of your assay performed for each of the aforementioned biomarkers.
Assessment
For ER and PR there are at least two cell lines with a heterogeneous expression of these proteins. The others are either homogeneously positive or negative. The heterogeneous cells react by more or less of the cells staining depending on whether the assay over or under performs. For Her2 there are two 1+ cell lines that provide the sensitivity to determine whether the assay has worked effectively. As indicators of assay performance they are ideal.

Figure1

Figure 1 shows the relative number of Her2 receptors associated with each Her2 scores (see the blue line). This was performed on the Oracle Her2 cell lines and illustrates the absence of any linear correlation across all four scores (see yellow dotted line). The only linear correlation seen is between 0, 1+ and 2+ (see red dotted line). If the assay was to fluctuate the 1+ cell line will become negative or score as high as 2+. In a known standardised 1+ cell line, this assay fluctuation is potentially easier to determine than in a 2+ cell. The 2+ cell score is often the score of most discordance2. HistoCyte Laboratories Ltd have developed a cost effective control material robust and cost effective enough for same slide use.
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