Weighing the Pros and Cons of Negative Reagent Controls in the Clinical Diagnostic Laboratory: Approaches to Quality Control in the Immunohistochemical Laboratory



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Media Contact: Ron Martin


AUSTIN, Texas (October 3, 2013) – Regulatory and economic pressures have forced clinical diagnostic laboratories to look for more ways to cut costs and shorten turnaround times, decreasing or eliminating potentially redundant or unnecessary quality control measures. Immunohistochemical (IHC) assays are an integral part of histopathological diagnosis in oncology and cancer medicine, with life and death decisions hanging on the accuracy and quality of those test results. Several regulatory guidelines have been reworded that seem to give medical laboratory directors more discretion in determining the use of negative reagent controls in IHC assays. This, along with recent improvement in IHC assay technology, has led to the possibility of laboratories utilizing fewer quality control slides in an effort to cut costs.

“Medical diagnostic laboratories do not want to be in a position of compromising patient care in the name of cost-cutting,notes Robert L. Michel, Editor-in-Chief of DarkDaily.com and The Dark Report. In the area of quality controls, it’s important that immunohistochemistry laboratory directors and laboratory vendors seriously consider the pros and cons of new technologies and work flow innovations that can improve quality and patient safety.”

The Dark Report is pleased to offer a recently published FREE White Paper, “Identifying False-Positive Results in Immunohistochemical Assays: The value of negative reagent controls in the clinical laboratory.”  Published by The Dark Report and Dark Daily,  it is available free to laboratory professionals as a PDF download.

Along with other topics, this FREE White Paper specifically addresses:

• The types of negative controls used in immunohistochemical (IHC) assays

• The conditions that can cause variability in IHC assays that make negative controls necessary

• A discussion of the arguments for and against the use of negative reagent controls (NRCs)

• A list of topics for laboratory directors to consider when deciding whether to continue negative reagent control slides

• A discussion of the implications for laboratories that choose to cut back on the use of NRCs for IHC testing.

The paper’s authors are Dr. Eric Walk, MD, FCAP and Dr. Peter Banks, MD, FCAP. Dr. Walk is the Senior Vice President for Medical & Scientific Affairs and the Chief Medical Officer for Ventana Medical Systems, Inc.  In this position he oversees the Medical Affairs/Pathology, Scientific Affairs, Clinical Affairs, Biostatistics/Data Management, Medical Innovation, and Tissue Sample Management functions. Dr. Banks is a pathologist in Scientific Affairs at Ventana Medical Systems, Inc. Board-certified in Anatomic Pathology and a CAP Fellow, Dr. Banks is also a Clinical Professor of Pathology at the University of North Carolina, Chapel Hill.

This White Paper, “Identifying False-Positive Results in Immunohistochemical Assays: The value of negative reagent controls in the clinical laboratory” is available for free download as a PDF at http://darkdaily.com/white-papers/identifying-false-positive-results-in-immunohistochemical-assays-the-value-of-negative-reagent-controls-in-the-clinical-laboratory-93013. It is part of the Dark Daily Resource Center, which has a growing library of White Papers and other information resources tailored specifically for the needs of laboratory administrators, lab managers, pathologists, and lab industry consultants.

For additional information, Contact: Ron Martin, 512-264-7103


Established in 1995, THE DARK REPORT  is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely-read by leaders in laboratory medicine and diagnostics. The DARK REPORT produces the famous Executive War College on Laboratory and Pathology Management (every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals), Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.