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Chapter 2 - Immunohistochemistry Quality Assurance and Quality Control

Published online by Cambridge University Press:  16 June 2022

By
Bronwyn Christiansen  and
Hazel Chambers
Edited by
Trung Nguyen
Trung Nguyen
Affiliation:
Peter MacCallum Cancer Centre, Australia
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Summary

Many parameters are associated with IHC testing assays. With so many variables, it is quite easy to accumulate errors within the system. To make things more manageable, these considerations are categorized into three main groups. Pre-analytic aspects occur before the assay, analytic factors are concerned with the staining protocol and post-analytic elements relate to interpreting of results. It has also come to reason that any one variable can impact the reliability and consistency of the overall IHC assay. In this regard, standardization requirements have been enlisted to assist laboratories achieve optimal results. In addition, monitoring proficiency testing regimens and various organizations are in place to ensure high levels of standards are attained. All these endeavours are known as quality assurance and quality control measures. They are arranged under the overall umbrella of a facility’s quality management system.

Keywords

pre-analyticanalyticpost-analyticvariablesparametersin vitro diagnosticresearch use onlystandardizationquality managementTherapeutic Goods Administration (TGA)
Type
Chapter
Information
Immunohistochemistry
A Technical Guide to Current Practices
 , pp. 24 - 66
Publisher: Cambridge University Press
Print publication year: 2022

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References

Agilent 2021. Dako proteinase K ready to use package insert (online). Available at www.agilent.com/cs/library/packageinsert/public/301326EN_02.pdf (Accessed 1 June 2021).Google Scholar
Ananthanarayanan, V, Pins, MR, Meyer, RE, Gann, PH 2005. Immunohistochemical assays in prostatic biopsies processed in Bouin’s fixative. J Clin Pathol 58(3):322–4.CrossRefGoogle ScholarPubMed
Bogen, SA 2019. A root cause analysis into the high error rate in clinical immunohistochemistry. Appl Immunohistochem Mol Morphol 27(5):329–38.CrossRefGoogle ScholarPubMed
Bromley, CM, Palechek, PL, Benda, JA 1994. Preservation of estrogen receptor in paraffin sections. Journal of Histotechnology 17(2):115–18.CrossRefGoogle Scholar
Brügmann, A, Eld, M, Lelkaitis, G, Nielsen, S, Grunkin, M, Hansen, JD, Foged, NT, Vyberg, M 2012. Digital image analysis of membrane connectivity is a robust measure of HER2 immunostains. Breast Cancer Res Treat 132(1):41–9.CrossRefGoogle ScholarPubMed
Carson, FL, Hladik, C 2009. Histotechnology: A self-instructional text. American Society of Clinical Pathology Press.Google Scholar
Cates, JMM, Troutman, KA Jr 2015. Quality management of the immunohistochemistry laboratory: A practical guide. Appl Immunohistochem Mol Morphol 23(7): 471–80.CrossRefGoogle ScholarPubMed
College of American Pathologists 2009. Definition of quality assurance, quality control, and quality improvement. CAP (online). Available at www.cap.org/apps/cap.portal (Accessed 30 May 2020).Google Scholar
College of American Pathologists 2017. Standards for laboratory accreditation 2017 edition. CAP (online). Available at https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/WebApplications/shared-assets/lap-standards.pdf (Accessed 30 May 2020).Google Scholar
Drew, T, Vo, MLH, Wolfe, JM 2013. The invisible gorilla strikes again: Sustained inattentional blindness in expert observers. Psychol Sci 24(9):1848–53.Google Scholar
Engel, KB, Moore, HM 2011. Effects of preanalytical variables on the detection of proteins by immunohistochemistry in formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med 135(5):537–43.CrossRefGoogle ScholarPubMed
Evans, KK, Birdwell, RL, Wolfe, JM 2013. If you don’t find it often, you often don’t find it: Why some cancers are missed in breast cancer screening. PLoS One 8(5):e64366.CrossRefGoogle ScholarPubMed
Gown, AM 2016. Diagnostic immunohistochemistry: What can go wrong and how to prevent it. Arch Pathol Lab Med 140(9):893–8.CrossRefGoogle Scholar
Hayat, MA 2002. Microscopy, immunohistochemistry, and antigen retrieval methods: For light and electron microscopy. Kluwer Academic.Google Scholar
Health 2020. Therapeutic goods (medical devices) regulations 2002. Australian government (online). Available at www.legislation.gov.au/Details/F2020C00112 (Accessed 30 May 2020).Google Scholar
Hewitt, SM, Baskin, DG, Frevert, CW, Stahl, WL, Rosa-Molinar, E 2014. Controls for immunohistochemistry: The Histochemical Society’s standards of practice for validation of immunohistochemical assays. J Histochem Cytochem 62(10):693–7.CrossRefGoogle ScholarPubMed
Hewitt, SM, Lewis, FA, Cao, Y, Conrad, RC, Cronin, M, Danenberg, KD, Goralski, TJ, Langmore, JP, Raja, RG, Williams, PM, Palma, JF, Warrington, JA 2008. Tissue handling and specimen preparation in surgical pathology: Issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med 132(12):1929–35.CrossRefGoogle ScholarPubMed
Jackson, P, Blythe, D 2008. Immunohistochemical techniques. In Bancroft, JD, Gamble, M, eds. Theory and practice of histological techniques. Churchill Livingstone Elsevier; 433–72.Google Scholar
Jacobs, TW, Prioleau, JE, Stillman, IE, Schnitt, SJ 1996. Loss of tumor marker-immunostaining intensity on stored paraffin slides of breast cancer. J Natl Cancer Inst 88(15):1054–9.CrossRefGoogle ScholarPubMed
Kakimoto, K, Takekoshi, S, Miyajima, K, Osamura, RY 2008. Hypothesis for the mechanism for heat-induced antigen retrieval occurring on fresh frozen sections without formalin-fixation in immunohistochemistry. J Mol Histo 39(4):389–99.Google ScholarPubMed
Leong, AS, Lee, ES, Yin, H, Kear, M, Haffajee, Z, Pepperall, D 2002. Superheating antigen retrieval. Appl Immunohistochem Mol Morphol 10(3):263–8.CrossRefGoogle ScholarPubMed
Levenson, RM, Krupinski, EA, Navarro, VM, Wasserman, EA 2015. Pigeons (Columba livia) as trainable observers of pathology and radiology breast cancer images. PLoS One 10(11):e0141357.CrossRefGoogle ScholarPubMed
Lin, F, Chen, Z 2014. Standardization of diagnostic immunohistochemistry: Literature review and Geisinger experience. Arch Pathol Lab Med 138(12):1564–77.CrossRefGoogle ScholarPubMed
McCampbell, AS, Raghunathan, V, Tom-Moy, M, Workman, RK, Haven, R, Ben-Dor, A, Rasmussen, OF, Jacobsen, L, Lindberg, M, Yamada, NA, Schembri, C 2017. Tissue thickness effects on immunohistochemical staining intensity of markers of cancer. Appl Immunohistochem Mol Morphol 27(5):345–55.Google Scholar
McMahon, L 2018. The impact of decalcification on staining. Leica Biosystems (online). Available at www.leicabiosystems.com/knowledge-pathway/the-impact-of-decalcification-on-staining (Accessed 30 May 2020).Google Scholar
Miyatake, Y, Ikeda, H, Michimata, R, Koizumi, S, Ishizu, A, Nishimura, N, Yoshiki, T 2004. Differential modulation of gene expression among rat tissues with warm ischemia. Exp Mol Path 77(3):222–30.CrossRefGoogle ScholarPubMed
NATA 2016. NATA agreements update: Memorandum of understanding with TGA. National Association of Testing Authorities (online). Available at www.nata.com.au/nata-articles/150-nata-agreements-update-memorandum-of-understanding-with-tga (Accessed 30 May 2020).Google Scholar
NATA 2018. Technical circular – General accreditation guidance – Validation and verification of quantitative and qualitative test methods. National Association of Testing Authorities (online). Available at www.nata.com.au/phocadownload/gen-accreditation-guidance/Validation-and-Verification-of-Quantitative-and-Qualitative-Test-Methods.pdf (Accessed 30 May 2020).Google Scholar
NATA 2019. General accreditation criteria ISO 15189 standard application document, July 2019. National Association of Testing Authorities (online). Available at www.nata.com.au/phocadownload/gen-accreditation-criteria/ISO-15189-Application-Document-Medical-Testing-Supplementary-Requirements-for-Accreditation.pdf (Accessed 30 May 2020).Google Scholar
NCCLS 1999. Quality assurance for immunocytochemistry: Approved guideline. MM4-A Vol. 19 No. 26. Clinical and Laboratory Standards Institute (formerly NCCLS) (online). Available at http://demo.nextlab.ir/getattachment/50d8822a-bdd5-4f7d-b712-d5f5737d4d76/CLSI-MM4-A.aspx (Accessed 30 May 2020).Google Scholar
NPAAC 2018. Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth edition). Australian Government Department of Health (online). Available at www1.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-dhaivd-2018 (Accessed 30 May 2020).Google Scholar
NPAAC 2020. Requirements for use of digital images as an alternative to direct microscopy (draft). Australian Government Department of Health (online). Available at www1.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-publications-draft.htm (Accessed 30 May 2020).Google Scholar
Prioleau, J, Schnitt, SJ 1995. p53 antigen loss in stored paraffin slides. N Engl J Med 332(22):1521–2.Google Scholar
Ramos-Vara, JA, Beissenherz, ME 2000. Optimization of immunohistochemical methods using two different antigen retrieval methods on formalin-fixed paraffin-embedded tissues: Experience with 63 markers. J Vet Diagn Invest 12(4):307–11.CrossRefGoogle ScholarPubMed
RCPA 2018. Ethical and legal issues in relation to the use of human tissue in Australia and New Zealand. Royal College of Pathologists of Australasia (online). Available at www.rcpa.edu.au/getattachment/ad0d4af1-901a-4056-af05-56bbc06167c1/Ethical-and-Legal-Issues-in-Relation-to-the-Use-of.aspx (Accessed 30 May 2020).Google Scholar
RCPA 2019. Cancer protocols: Published protocols. 2nd edition. Royal College of Pathologists of Australasia (online). Available at www.rcpa.edu.au/Library/Practising-Pathology/Structured-Pathology-Reporting-of-Cancer/Cancer-Protocols (Accessed 1 June 2021).Google Scholar
Roche 2018. Tissue diagnostics product catalog 2019. Roche Diagnostics Corporation (online). Available at https://diagnostics.roche.com/content/dam/diagnostics/us/en/resource-center/Tissue-product-catalog-2019.pdf (Accessed 31 July 2021).Google Scholar
Røge, R, Riber-Hansen, R, Nielsen, S, Vyberg, M 2016. Proliferation assessment in breast carcinomas using digital image analysis based on virtual Ki67/cytokeratin double staining. Breast Cancer Res Treat 158(1):11–19.CrossRefGoogle ScholarPubMed
Rolls, G 2013. An introduction to decalcification. Leica Biosystems (online). Available at www.leicabiosystems.com/knowledge-pathway/an-introduction-to-decalcification (Accessed 30 May 2020).Google Scholar
Rolls, G 2016. Steps to better grossing. Leica Biosystems (online). Available at www.leicabiosystems.com/knowledge-pathway/steps-to-better-grossing (Accessed 30 May 2020).Google Scholar
Rolls, G 2019. An introduction to specimen processing. Leica Biosystems (online). Available at www.leicabiosystems.com/knowledge-pathway/an-introduction-to-specimen-processing (Accessed 30 May 2020).Google Scholar
Sanderson, T, Zardin, G 2013. Immunohistochemistry quality control. In Suvarna, K, Layton, C, Bancroft, JD, eds. Bancroft’s theory and practice of histological techniques. Churchill Livingstone Elsevier; 435–54.Google Scholar
Shi, SR, Cote, RJ, Liu, C, Yu, MC, Castelao, JE, Ross, RK, Taylor, CR 2002. A modified reduced-temperature antigen retrieval protocol effective for use with a polyclonal antibody to cyclooxygenase-2 (PG 27). Appl Immunohistochem Mol Morph 10(4):368–73.CrossRefGoogle ScholarPubMed
Shi, SR, Cote, RJ, Taylor, CR 1997. Antigen retrieval immunohistochemistry: Past, present, and future. J Histochem Cytochem 45(3):327–43.Google Scholar
Shi, SR, Imam, SA, Young, L, Cote, RJ, Taylor, CR 1995. Antigen retrieval immunohistochemistry under the influence of pH using monoclonal antibodies. J Histochem Cytochem 43(2):193–201.Google Scholar
Shi, SR, Key, ME, Kalra, KL 1991. Antigen retrieval in formalin-fixed, paraffin-embedded tissues: an enhancement method for immunohistochemical staining based on microwave oven heating of tissue sections. J Histochem Cytochem 39(6):741–8.CrossRefGoogle ScholarPubMed
Shi, SR, Liu, C, Pootrakul, L, Tang, L, Young, A, Chen, R, Cote, RJ, Taylor, CR 2008. Evaluation of the value of frozen tissue section used as ‘gold standard’ for immunohistochemistry. Am J Clin Pathol 129(3):358–66.Google Scholar
Singh, PP, Sood, NK 2017. A combination of antigen retrieval methods significantly enhances the unmasking of tedious antigens of lymphangiogenesis and angiogenesis in canine mammary tumour. Journal of Biosciences and Medicines 5(12):44–55.CrossRefGoogle Scholar
TGA 2018. Regulatory requirements for in-house IVDs: What is an in-house IVD? Australian Government Department of Health (online). Available at www.tga.gov.au/book-page/what-house-ivd (Accessed 30 May 2020).Google Scholar
Therapeutic Goods Act 1989 Sect 41BD What is a medical device? Commonwealth Consolidated Acts (online). Available at http://classic.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s41bd.html (Accessed 31 May 2020).Google Scholar
Torlakovic, EE, Francis, G, Garratt, J, Gilks, B, Hyjek, E, Ibrahim, M, Miller, R, Nielsen, S, Petcu, EB, Swanson, PE, Taylor, CR, Vyberg, M 2014. Standardization of negative controls in diagnostic immunohistochemistry: Recommendations from the international ad hoc expert panel. Appl Immunohistochem Mol Morphol 22(4):241–52.CrossRefGoogle ScholarPubMed
Torlakovic, EE, Nielsen, S, Vyberg, M, Taylor, CR 2015. Getting controls under control: The time is now for immunohistochemistry. J Clin Pathol 68(11):879–82.Google Scholar
Vyberg, M, Nielsen, S 2016. Proficiency testing in immunohistochemistry: Experiences from Nordic Immunohistochemical Quality Control (NordiQC). Virchows Archiv 468(1):19–29.Google Scholar
Vyberg, M, Torlakovic, E, Seidal, T, Risberg, B, Helin, H, Nielsen, S 2005. Nordic Immunohistochemical Quality Control. Croat Med J 46(3):368–71.Google Scholar
Williams, C, Pontén, F, Moberg, C, Söderkvist, P, Uhlén, M, Pontén, J, Sitbon, G, Lundeberg, J 1999. A high frequency of sequence alterations is due to formalin fixation of archival specimens. Am J Pathol 155(5):1467–71.Google Scholar
Williams, JH, Mepham, BL, Wright, DH 1997. Tissue preparation for immunocytochemistry. J Clin Pathol 50(5):422–8.Google Scholar
Yamashita, S, Okada, Y 2005. Mechanisms of heat-induced antigen retrieval: Analyses in vitro employing SDS-PAGE and immunohistochemistry. J Histochem Cytochem 53(1):13–21.Google Scholar

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