False-Positives-Ammunoistochemical-Assay-coverSource: ©2013 Dark Intelligence Group, Inc.Regulatory and economic pressures have forced clinical diagnostic labs to look for more ways to cut costs and shorten turnaround times, which may result in 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 critical decisions being made based on the accuracy and quality of those test results.

Several regulatory guidelines have been reworded that seem to give medical lab 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 labs using fewer quality control slides, aiming to cut costs.

“Medical diagnostic laboratories do not want to be in a position of compromising patient care in the name of cost-cutting,” says Robert L. Michel, editor-in-chief, 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 offering lab professionals a free download of its recently published white paper titled “Identifying False-Positive Results in Immunohistochemical Assays: The value of negative reagent controls in the clinical laboratory.”

Among the topics addressed:

• 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 authors are:

  • Eric Walk, MD, FCAP, senior vice president, medical and scientific affairs and chief medical officer, Ventana Medical Systems Inc, Tucson, Ariz. Walk oversees the medical affairs/pathology, scientific affairs, clinical affairs, biostatistics/data management, medical innovation, and tissue sample management functions.
  • Peter Banks, MD, FCAP, a pathologist in scientific affairs at Ventana Medical Systems. Board-certified in anatomic pathology and a CAP Fellow, Banks is also a clinical professor of pathology, University of North Carolina, Chapel Hill, NC.