Quality Control of Immunohistochemical and In Situ Hybridization Predictive Biomarkers for Patient Treatment: Experience from International Guidelines and International Quality Control Schemes
With the advent of routine predictive biomarking of cancers using immunohistochemistry and in situ hybridization, it has become essential to manage the assays involved with the highest standards of quality assurance at the internal and external quality control levels. This is to ensure the reproducibility and accuracy of generating, interpreting, and reporting what are classified as stand-alone Class III category results. To satisfy this need, it is required to use approved validated and standardized tests applied with suitable on-slide or batch controls to engender adequate internal control-based quality assurance. In addition, it is necessary for the laboratory to participate in external quality assurance schemes to align the performance of the assay and the quality of the assay results with regional, national, and international standards on a regular basis. The chapter is written to provide generic information for the reader on the principles and methodology involved for validation of predictive biomarker assays and the critical issues involved in their regular internal and external quality assurance from a perspective of applying these assays at the level of routine diagnostic laboratories as well as at centers of excellence dealing with the screening and reporting of the results of ongoing clinical trials.
KeywordsImmunohistochemical predictive cancer biomarkers Assay validation and standardization Internal and external quality control and assurance
College of American Pathologist
External quality assurance
Human epidermal growth factor receptor 2
Internal quality control
Mismatch repair (MLH1, PMS2, MSH2, MSH6)
- 5.Siegel J. Department of health & human services. 1998. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf.
- 6.Nordi QC. Recommended protocols. 2018. http://www.nordiqc.org/recommended.php
- 8.ICH Harmonised Tripartite Guideline – validation of analytical procedures: text and methodology Q2(R1). 2005.Google Scholar
- 9.Fitzgibbons PL, Bradley LA, Fatheree LA, Alsabeh R, Fulton RS, Goldsmith JD, et al. Principles of analytic validation of immunohistochemical assays – guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2014;138:1432–43.CrossRefPubMedGoogle Scholar
- 12.Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med. 2014;138(2):241–56.CrossRefPubMedCentralPubMedGoogle Scholar
- 13.Bartley AN, Washington MK, Ventura CB, Ismaila N, Colasacco C, Benson IIIAB, et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma guideline from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology. Arch Pathol Lab Med. 2016;140:1345–63.CrossRefPubMedGoogle Scholar
- 14.Hammond ME, Hayes DF, Wolff AC, Mangu PB, Temin S. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Oncol Pract. 2010;6(4):195–19.CrossRefPubMedCentralPubMedGoogle Scholar
- 22.Cheung CC, Garratt J, Won J, et al. Developing ALK immunohistochemistry and in situ hybridization proficiency testing for non-small cell lung cancer in Canada: Canadian immunohistochemistry quality control challenges and successes. Appl Immunohistochem Mol Morphol. 2015;23(10):677–81.CrossRefPubMedGoogle Scholar
- 23.International Quality Network for Pathology. Home page: http://www.iqnpath.org/.
- 25.NordiQC. NordiQC assessment scheme 2018. http://www.nordiqc.org/modules.php.
- 26.UK NEQAS. International quality expertise. UK NEQAS ICC & ISH modules. http://www.ukneqasiccish.org/modules/.
- 27.Quip. Qualitätssicherungs-initiative pathologie QuIP GmbH. Home page: https://quip.eu/en_GB/zerpa/trials/.
- 28.European Society of Pathology. EQA schemes; 2018: https://www.esp-pathology.org/esp-foundation/eqa-schemes.html.
- 29.College of American Pathologists. Home page: www.cap.org.
- 30.Canadian Partnership Against Cancer. Home page: http://cpqa.ca/.
- 31.The Royal College of Pathologists of Australasia: Quality Assurance Programs. Home page: https://www.rcpaqap.com.au/.
- 33.Becton, Dickinson and Company. Home page: http://www.bd.com/.
- 34.CAP Today. CAP partners with BD in China and India, August 1st, 2013. http://www.captodayonline.com/cap-partners-with-bd-in-china-and-india/.