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HER2/ER/PR IHControls® -Level H are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor (PR) IHC stains. It is indicated for use with formalin-fixed paraffin-embedded (FFPE) breast turnor samples. HER2/ER/PR IHControls® -Level H are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls® -Level H are an additional controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device. HER2/ER/PR IHControls® -Level M are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor type (PR) IHC stains. It is indicated for use with formalin-fixed paraffin-embedded (FFPE) breast turnor samples. HER2/ER/PR IHControls® -Level M are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls® -Level M are an additional controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device. HER2/ER/PR IHControls® -Level L are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor (PR) IHC stains. It is indicated for use with formalin-fixed paraffin-embedded (FFPE) breast tumor samples. HER2/ER/PR IHControls® -Level L are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls® -Level L are an additional control to the run controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device.

HER2/ER/PR IHControls® - Level H, HER2/ER/PR IHControls® - Level M and HER2/ER/PR IHControls® - Level L (HER2/ER/PR IHControls®) are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte. HER2/ER/PR IHControls® incorporate assay controls for human epidermal growth factor receptor type II (HER-2), estrogen receptor (ER), and progesterone receptor (PR). The HER2/ER/PR panel includes controls at 3 different analyte concentrations, providing users with an opportunity to select the control with an analyte concentration within the dynamic range of their assay. HER2/ER/PR IHControls® are provided in a small vial containing enough liquid suspension for at least 100 tests. The user is instructed to pipet a one microliter droplet onto the slide that also bears the patient sample. The droplet is a suspension containing microscopic glass microbeads that are approximately the same size as cells. The microbead surface bears the molecule(s) being measured. Peptides representing the epitopes of all of the major commercial HER2. ER. and PR antibodies used by clinical immunohistochemistry laboratories are incorporated into the products. HER2/ER/PR IHControls® are comprised of two different microbeads: analyte-coated glass test microbeads (7-8 um in diameter) and color standard microbeads (4.5 um in diameter). The latter provide a fixed brown color intensity for use in standardizing stain intensity measurement. The HER2/ER/PR IHControls® panel is provided at 3 different analyte concentrations. In descending order of concentration, these levels are denoted "H", "M", and "L". These different products allow matching the analyte concentration to the dynamic range of the laboratory's stain. Level H (high): This product includes analytes for HER2, ER, and PR, at approximately 10^6 molecules per microbead. Level M (medium): This product includes analytes for HER2, ER, and PR, at approximately 10^5 molecules per microbead. Level L (low): This product includes analytes for HER2, ER, and PR, at approximately 10^4 molecules per microbead. These concentrations are approximate; they are not intended as assayed controls. Three product levels are provided to allow the user to select a control with the lowest analyte concentration that still produces an easily visible immunostain. The immunoreactivity pattern for product levels H, M, and L is described in Table 1. The table indicates the primary antibodies corresponding with up to 9 separate HER2/ER/PR peptides. (Some peptides are immunoreactive with more than one primary antibody.) Level H has a narrower range of primary antibody immunoreactivity than levels M and L but the concentrations per microbead are higher. Although any individual primary antibody will be listed as potentially immunoreactive with 2 or more levels. IHC laboratories should use the lowest level that provides for an easily visible stain. Users pipette a droplet onto a microscope slide that also bears a patient's tissue sample. The droplet hardens upon drying, adheres the analyte-coated microbeads to the microscope slide, and is then processed with the patient sample. The hardened droplet is able to pass through dry heat associated with "baking" of slides, organic solvents associated with deparaffinization, boiling associated with antigen retrieval, and repeated rinses associated with immunostaining.

For in Vitro Diagnostic Use: QCS HER2 ImmunoControls, are intended for a laboratory to control semi-quantitative immunohistochemistry using different HER2/neu antibodies. Each QCS HER2 control slide contains four control sections prepared from breast cancer ccll lines that represent different levels of Her-2/neu protein expression. The cells are formalin-fixed and paraffin-embedded. These controls ensure that performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.

QCS HER2 ImmunoControls: This product provides appropriate control for semi-quantitative immunohistochemistry using polyclonal or monoclonal HER2/neu antibodies. Each slide contains four control sections prepared from breast cancer cell lines that represent different levels of Her-2/neu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, the slide is positively charged.