Certified to the EN ISO 13485:2016 standard for medical device quality management, HistoCyte Laboratories Ltd., based in Newcastle, UK; have a key expertise in Histopathology. Their aim is to deliver high quality, reproducible, and cost effective analyte control material.
The unique feature of these controls are that they are manufactured from cell lines. Identification of suitable archive tissue for use as controls in slide based assays can be difficult due to heterogeneous expression of biomarkers, fixation artefacts, rarity of their expression, or just general lack of availability. The novel technology developed by HistoCyte Laboratories Ltd employs cell lines to avoid these issues and allows to process the cell lines in to tissue-like controls. These controls also have the advantage of being manufactured to a reproducible standard and with inexhaustible supply. These cell line controls are as robust as tissue and are validated with all standardized assays. They are suitable quality controls for any laboratory employed to assess FFPE tissue.
HistoCyte Laboratories manufactures a range of cell line controls for same slide use in Immunohistochemistry (IHC) and In-situ hybridization (ISH). They have developed unique processes that allow production of high density cell preparations that retain their original morphology. Through careful selection of cell types, a range of positive and negative controls are generated to determine effective performance of reagents used in slide based assessments.
The products are available in a range of formats to suit the individual workflow and requirements of each laboratory.
Their product range includes
- Dynamic Range Controls – These controls give a full dynamic range of expression, and reflects the sensitivity of the assay, viz. Negative, Low expression, medium expression and High expression.
- Standard controls – These controls give a standard expression as a positive and negative to prove reagents have been applied to the slide correctly.
Each product is available as pre-cut slides or as full blocks of cell micro-arrays. Appropriate cell lines are selected that deliver the required range of expression for any given biomarker. This can be as simple as a positive and negative to prove reagents have been applied to the slide correctly, or as complex as a full range of expression to demonstrate assay sensitivity.