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Updated: Jul 29, 2026

Immunohistochemical Analysis in the Rat Central Nervous System and Peripheral Lymph Node Tissue Sections
Published on: November 14, 2016
Validation of nominally expired antibodies for immunohistochemistry
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.
Abstract:
The Histopathology Department at the Children's Hospital at Westmead has 114 antibodies in its Immunohistochemistry panel; 64 of these are purchased as concentrates and usually have expiration dates 1-2 years after receipt by the laboratory. To replace these antibodies after expiration would require approximately $40,000/year. It has been reported that continued use of these reagents beyond their expiration dates may be feasible. I used the iPassport quality management system to track antibody expiration dates and verified extended fit-for-purpose for these reagents. iPassport is web-based quality management software that assists medical laboratories with document control and quality management. Review of the records since the inception of iPassport in 2015 indicates no failed verifications and to date, the average life after expiration is 6 years; eight antibodies have exceeded 6 years. Some antibodies with exceptionally extended lifespans include factor 8 (21 years), factor 13a (19 years) and epithelial membrane antigen (17 years). Selecting antibodies to be discarded should be based on performance rather than expiration date alone. The iPassport quality management system has enabled permanent recording and periodic validation of nominally expired antibodies.
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