Proficiency testing in immunohistochemistry—experiences from Nordic Immunohistochemical Quality Control (NordiQC)

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• 作者：Mogens Vyberg ; Søren Nielsen
• 关键词：Immunohistochemistry ; NordiQC ; External quality assurance
• 刊名：Virchows Archiv
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：468
• 期：1
• 页码：19-29
• 全文大小：4,743 KB
• 参考文献：1.Taylor CR (2000) The total test approach to standardization of immunohistochemistry. Arch Pathol Lab Med 124(7):945–951PubMed
  2.Goldstein NS, Hewitt SM, Taylor CR, Yaziji H, Hicks DG, Members of Ad-Hoc Committee On Immunohistochemistry Standardization (2007) Recommendations for improved standardization of immunohistochemistry. Appl Immunohistochem Mol Morphol 15(2):124–133CrossRef PubMed
  3.Yaziji H, Taylor CR, Goldstein NS, Dabbs DJ, Hammond EH, Hewlett B, Floyd AD, Barry TS, Martin AW, Badve S, Baehner F, Cartun RW, Eisen RN, Swanson PE, Hewitt SM, Vyberg M, Hicks DG, Members of the Standardization Ad-Hoc Consensus Committee (2008) Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry. Appl Immunohistochem Mol Morphol 16(6):513–520. doi:10.​1097/​PAI.​0b013e31818a9d3a​ CrossRef PubMed
  4.Hammond ME, Hayes DF, Wolff AC, Mangu PB, Temin S (2010) 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 6(4):195–197. doi:10.​1200/​JOP.​777003 PubMedCentral CrossRef PubMed
  5.Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF, American Society of Clinical Oncology; College of American Pathologists (2014) 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 138(2):241–256. doi:10.​5858/​arpa.​2013-0953-SA PubMedCentral CrossRef PubMed
  6.Howat WJ, Lewis A, Jones P, Kampf C, Pontén F, van der Loos CM, Gray N, Womack C, Warford A (2014) Antibody validation of immunohistochemistry for biomarker discovery: recommendations of a consortium of academic and pharmaceutical based histopathology researchers. Methods 70(1):34–38. doi:10.​1016/​j.​ymeth.​2014.​01.​018 PubMedCentral CrossRef PubMed
  7.O’Hurley G, Sjöstedt E, Rahman A, Li B, Kampf C, Pontén F, Gallagher WM, Lindskog C (2014) Garbage in, garbage out: a critical evaluation of strategies used for validation of immunohistochemical biomarkers. Mol Oncol 8(4):783–798. doi:10.​1016/​j.​molonc.​2014.​03.​008 CrossRef PubMed
  8.Rv W, Hasselmann S, Rüschoff J, Fisseler-Eckhoff A, Kreipe H (2008) Proficiency testing of immunohistochemical biomarker assays in breast cancer. Virchows Arch 453(6):537–543. doi:10.​1007/​s00428-008-0688-4 CrossRef
  9.Torlakovic EE, Francis G, Garratt J, Gilks B, Hyjek E, Ibrahim M, Miller R, Nielsen S, Petcu EB, Swanson PE, Taylor CR, Vyberg M, International Ad Hoc Expert Panel (2014) Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international ad hoc expert panel. Appl Immunohistochem Mol Morphol 22(4):241–252. doi:10.​1097/​PAI.​0000000000000069​ PubMedCentral CrossRef PubMed
  10.Torlakovic EE, Nielsen S, Francis G, Garratt J, Gilks B, Goldsmith JD, Hornick JL, Hyjek E, Ibrahim M, Miller K, Petcu E, Swanson PE, Zhou X, Taylor CR, Vyberg M (2015) Standardization of positive controls in diagnostic immunohistochemistry: recommendations from the International Ad Hoc Expert Committee. Appl Immunohistochem Mol Morphol 23(1):1–18. doi:10.​1097/​PAI.​0000000000000163​ CrossRef PubMed
  11.Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee, Torlakovic EE, Riddell R, Banerjee D, El-Zimaity H, Pilavdzic D, Dawe P, Magliocco A, Barnes P, Berendt R, Cook D, Gilks B, Williams G, Perez-Ordonez B, Wehrli B, Swanson PE, Otis CN, Nielsen S, Vyberg M, Butany J (2010) Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee/Immunohistochemistry: best practice recommendations for standardization of immunohistochemistry tests. Am J Clin Pathol 133(3):354–365. doi:10.​1309/​AJCPDYZ1XMF4HJWK​ CrossRef
  12.Copete M, Garratt J, Gilks B, Pilavdzic D, Berendt R, Bigras G, Mitchell S, Lining LA, Cheung C, Torlakovic EE (2011) Inappropriate calibration and optimisation of pan-keratin (pan-CK) and low molecular weight keratin (LMWCK) immunohistochemistry tests: Canadian Immunohistochemistry Quality Control (CIQC) experience. J Clin Pathol 64(3):220–225. doi:10.​1136/​jcp.​2010.​085258 CrossRef PubMed
  13.Borrisholt M, Nielsen S, Vyberg M (2013) Demonstration of CDX2 is highly antibody dependant. Appl Immunohistochem Mol Morphol 21(1):64–72. doi:10.​1097/​PAI.​0b013e318257f8aa​ PubMed
  14.Kadota K, Nitadori JI, Rekhtman N, Jones DR, Adusumilli PS, Travis WD (2015) Reevaluation and reclassification of resected lung carcinomas originally diagnosed as squamous cell carcinoma using immunohistochemical analysis. Am J Surg Pathol 39(9):1170–80 doi:10.​1097/​PAS.​0000000000000439​
  15.Travis, WD, Brambilla, E, Burke, AP, Marx, A, Nicholson, AG (eds) (2015) WHO classification of tumours of the lung, pleura, thymus and heart. 4th edn. IARC: Lyon
  16.Gown A (2015) Next generation immunohistochemistry. http://​nordiqc2015.​dk/​allen-gown.​aspx (accessed 23rd of July 2015)
  17.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):41–49. doi:10.​1007/​s10549-011-1514-2 CrossRef PubMed
  18.Brügmann AH, Grunkin M, Nielsen S, Jensen V, Heikkilä P, Gaspar V, Vyberg M (2015) Image analysis of breast cancer HER2 protein expression used in assessment of staining quality. Virchows Archiv Vol. 465, Nr. Suppl 1, OFP-07-014, 2014, s. S20. doi:10.​1007/​s00428-014-1618-2 (accessed 23rd of July 2015)
  
• 作者单位：Mogens Vyberg (1) (2)
  Søren Nielsen (1)
  
  1. NordiQC, Institute of Pathology, Aalborg University Hospital, Aalborg, Denmark
  2. Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Pathology
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1432-2307

文摘

Despite extensive use of immunohistochemistry (IHC) for decades, lack of standardization remains a major problem, even aggravated in the era of targeted therapy. Nordic Immunohistochemical Quality Control (NordiQC) is an international academic proficiency testing (PT) program established in 2003 primarily aimed at assessing the analytical phases of the laboratory IHC quality. About 700 laboratories from 80 countries are currently participating. More than 30,000 IHC slides have been evaluated during 2003–2015. Overall, about 20 % of the staining results in the breast cancer IHC module and about 30 % in the general module have been assessed as insufficient for diagnostic use. The most common causes for insufficient results are less successful antibodies (poor and less robust antibodies, poorly calibrated ready-to-use (RTU) products, and stainer platform-dependent antibodies; 17 %), insufficiently calibrated antibody dilutions (20 %), insufficient or erroneous epitope retrieval (27 %), less sensitive visualization systems (19 %), and other (heat- and proteolysis-induced impaired morphology, endogenous biotin reaction, drying out phenomena, stainer platform-dependant protocol issues; 17 %). Approximately, 90 % of the insufficient results are characterized by either a too weak or false negative staining, whereas in the remaining 10 %, a poor signal-to-noise ratio or false positive staining is seen. Individually tailored recommendations for protocol optimization and identification of best tissue controls to ensure appropriate calibration of the IHC assay have for many markers improved IHC staining as well as inter-laboratory consistency of the IHC results. RTUs will not always provide an optimal result and data sheets frequently misguide the laboratories hampering the improvement in IHC quality. The overall data generated by NordiQC during 12 years indicates that continuous PT is valuable and necessary. Detailed description of the results of the NordiQC programme is available on www.​nordiqc.​org and summarized in this paper. Keywords Immunohistochemistry NordiQC External quality assurance