Validation of nominally expired antibodies for immunohistochemistry

Anthony F Henwood1,2

  • 1The Children's Hospital at Westmead, Australia.

Insights

Histopathology laboratories can extend the use of antibodies beyond expiration dates. Continuous quality management and performance verification ensure reagent efficacy, saving significant costs.

Area of Science:

  • Laboratory Medicine
  • Histopathology
  • Quality Management Systems

Background:

  • The Histopathology Department utilizes 114 immunohistochemistry antibodies, with 64 purchased as concentrates.
  • Antibody replacement costs approximately $40,000 annually due to 1-2 year expiration dates.

Purpose of the Study:

  • To assess the feasibility of using antibodies beyond their expiration dates.
  • To verify the extended fit-for-purpose of reagents using a quality management system.
  • To reduce laboratory reagent expenditure.

Main Methods:

  • Utilized the iPassport quality management system to track antibody expiration.
  • Performed periodic validation of antibodies past their expiration dates.
  • Reviewed records from 2015 to assess reagent longevity.

Main Results:

  • No failed verifications were recorded for antibodies used beyond expiration.
  • The average extended lifespan of antibodies is 6 years, with some exceeding 17-21 years.
  • Specific antibodies like factor 8, factor 13a, and epithelial membrane antigen showed exceptional longevity.

Conclusions:

  • Antibody usability should be determined by performance, not solely expiration dates.
  • The iPassport system facilitates the permanent recording and validation of nominally expired antibodies.
  • Extending antibody use beyond expiration significantly reduces costs without compromising quality.