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Updated: Mar 7, 2026
A Next-generation Tissue Microarray ngTMA Protocol for Biomarker Studies
Published on: September 23, 2014
3D Tissue Microarray Controls: A Potential Standardization Solution
Charles W Myers1, Sonal Bhimji-Patel1, Mark Rees2
1Emory University Hospital, Atlanta, GA.
Insights
A novel 3D tissue microarray control (3D TMAC) offers a solution for standardizing immunostains in anatomic pathology. This histoid control demonstrated good reproducibility and staining quality for multiple antibodies, improving quality control.
Area of Science:
- Anatomic Pathology
- Histopathology
- Quality Control
Background:
- Standardization of immunostain controls is a significant challenge in anatomic pathology due to inter-laboratory variations.
- Differential processing and preanalytical issues lead to inconsistent immunostain intensities.
- Existing histoid controls like xenografts or cell lines lack recent development and follow-up.
Purpose of the Study:
- To introduce a novel histoid control, the 3D tissue microarray control (3D TMAC), for improved control standardization.
- To evaluate the staining quality and reproducibility of the 3D TMAC using common antibodies in breast and cervical cancer diagnostics.
- To assess the potential of 3D TMAC in enhancing intralaboratory and interlaboratory standardization practices.
Main Methods:
- Development and implementation of a 3D tissue microarray control (3D TMAC).
- Testing of 3D TMAC with 11 antibodies relevant to breast and cervical cancer workups.
- Evaluation of staining quality and reproducibility over a 5-day period for CK5 and HER2 antibodies.
- Assessment of staining using both visual and computer-assisted methods.
Main Results:
- The 3D TMAC demonstrated appropriate staining for 9 out of 11 tested antibodies.
- Mammoglobin and GCDFP antibodies showed inappropriate staining, while p16 and mammoglobin did not exhibit expected staining properties.
- Excellent reproducibility for CK5 and HER2 staining was observed, with low coefficients of variation (3.58% and 3.18% respectively).
Conclusions:
- The 3D TMAC shows significant potential for improving intralaboratory and interlaboratory standardization in anatomic pathology.
- This novel control offers a reliable method for consistent immunostaining quality control.
- Further validation is warranted to fully establish the 3D TMAC as a standard in pathology diagnostics.
Abstract:
The use of controls is a hallmark for quality control in anatomic pathology. However, standardization of controls between laboratories has been a significant issue. Differential processing techniques between institutions and a multitude of preanalytical difficulties can result in different immunostain intensities. So called histoid controls, xenografts or culture cell lines, have been discussed in the past but with no recent followup. Herein is presented a histoid termed a 3D tissue microarray control (3D TMAC) control to help alleviate the burgeoning need for control standardization. A breast and cervix 3D TMAC control were tested for staining quality for 11 different antibodies commonly tested in either breast or cervical cancer work ups. We additionally looked at a small run of 5 days of CK5 and HER2 for reproducibility of the 3DRSTMA. Staining quality of 9 of the antibodies stained appropriately and 2 stained inappropriately, mammoglobin and GCDFP. Two of the antibodies were not reported to have any staining properties in the 3D TMAC, p16 and mammoglobin. Of these, p16 had appropriate staining and mammoglobin did not. In the 5 runs of CK5 and HER2, there was good reproducibility between stains assessed by both visual and computer-assisted methods, with membrane intensity coefficients of variation of 3.58% and 3.18%, respectively. The 3D TMAC has the potential to markedly improve intralaboratory and interlaboratory standardization practices.
