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Quality and Confidence in Tissue Diagnostics by Keith Miller of UKNEQAS

The Current Situation

In today’s cellular pathology service laboratories there is an ever increasing pressure to obtain more information from biopsies and the smaller resection samples generally provided for tissue diagnostics. This, combined with the ongoing demand for improving the quality of service, means that a suitable, high quality control material is imperative to a timely and correct diagnosis. The cost of finding this material from tissue banks and archives is often not fully appreciated. Moreover, for rare biomarkers or semi-quantitative assays, the demand for tissues with appropriate expression levels often exceeds the supply.
UKNEQAS (the United Kingdom National External Quality Assurance Scheme for ICC and ISH) assessments have often noted that internal control tissue being used routinely in subscribing laboratories is inappropriate or incomplete. The lack of availability of suitable control tissue means a laboratory may only have some of the tissue required to demonstrate the necessary expression levels of a given biomarker optimally. This finding highlights an increasing need for standardised control material for IHC and ISH testing, which in turn introduces the challenge of providing a cost effective solution that can be applied to every case tested.

Use of Cell Lines as Control Material - A Potential Solution

This requirement for standardised, reproducible control material of suitable protein expression was the reason that UKNEQAS originally investigated the use of cell lines for their Her2 assessment modules.1 This work was further developed in Newcastle upon Tyne and made robust on an industrial scale at Leica Biosystems Ltd. These cell lines were validated in a number of ways and jointly described in further work.2 Since then UKNEQAS has investigated a number of other areas where cell lines can be used as high quality control material, such as estrogen and progesterone receptor (ER and PR) assessment and, more recently, with ALK.

HistoCyte Laboratories Ltd

HistoCyte Laboratories Ltd builds on a track record in the IHC and ISH field. They are developing high quality analyte controls aimed at some of the more demanding assays that laboratories perform on a daily basis. These cell line control products remove the burden of locating, characterising and managing banks of precious control material and also avoid any ethical issues surrounding the use of patient material as controls. The adoption of well characterised, inexhaustible control material also means the introduction to the market of a universally accepted standard. This will bring about an increase in the quality of laboratory practice generally, which can only be a good thing.
I am very excited by what HistoCyte Laboratories Ltd will bring to this field and look forward to collaborating with Ian Milton and Colin Tristram as I have done in their previous enterprises. UKNEQAS works closely with industry partners in order to deliver high quality solutions to our colleagues in laboratories throughout the UK and beyond. Only through collaborating with the industry can we ensure that our needs are met and ultimately make sure quality services are delivered to the patient.


Keith Miller, FIBMS

Keith Miller has worked in the field of immunohistochemistry for over 30 years. He was previously the Technical Head of UCL-Advanced Diagnostics (formerly known as the UCL Immunocytochemistry Unit) since 1982. As Director of the UKNEQAS-ICC&ISH since 1992, Keith has recently helped establish an independent “not for profit” laboratory service Cancer Diagnostic Quality Assurance Services, Community Interest Company (CADQAS CIC) for UKNEQAS in order to support both the scheme and the tissue diagnostics community, including those in the commercial sector such as HistoCyte Laboratories Ltd.

1Rhodes, A., Jasani, B., Couturier, J., McKinley, M. J., Morgan, J. M., Dodson, A. R., Navabi, H., Miller, K. D. and Balaton, A. J. A formalin fixed, paraffin processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. American Journal of Clinical Pathology, 2002. 117. pp. 81-89.2Bogen SA, Vani K, McGraw B, Federico V, Habib I, Zeheb R, Luther E, Tristram C, Sompuram SR. Experimental validation of peptide immunohistochemistry controls. Appl Immunohistochem Mol Morphol. 2009 May;17(3):239-46.