Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center

Archives of Pathology and Laboratory Medicine

Volumn 138, Issue 11, 2014, Pages 1432-1443

  Fitzgibbons, Patrick L ^a   Linda, A Bradley ^b   Lisa, A Fatheree ^c   Alsabeh, Randa ^d   Regan, S Fulton ^e   Jeffrey, D Goldsmith ^f   Thomas, S Haas ^g   Karabakhtsian, Rouzan G ^h   Patti, A Loykasek ⁱ   Marolt, Monna J ^j   Steven, S Shen ^k   Anthony, T Smith ^c   Swanson, Paul E ^l  

^a ST JUDE MEDICAL CENTER   (United States)

^b BROWN UNIVERSITY   (United States)

^c North Carolina   (United States)

^d KAISER PERMANENTE MEDICAL CENTER   (United States)

^e PHENOPATH LABORATORIES   (United States)

^f BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^g MERCY HEALTH SYSTEM   (United States)

^h MONTEFIORE MEDICAL CENTER   (United States)

ⁱ Regional Medical Laboratories   (United States)

^j UNIVERSITY OF MINNESOTA MEDICAL CENTER   (United States)

^k HOUSTON METHODIST HOSPITAL   (United States)

^l UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EXPERT WITNESS; HUMAN; IMMUNOHISTOCHEMISTRY; LABORATORY; MEDICAL SOCIETY; PATHOLOGY; QUALITY CONTROL; STANDARDS; UNITED STATES; VALIDATION STUDY;

EXPERT TESTIMONY; HUMANS; IMMUNOHISTOCHEMISTRY; LABORATORIES; PATHOLOGY, CLINICAL; QUALITY CONTROL; SOCIETIES, MEDICAL; UNITED STATES;

EID: 84923930057     PISSN: 00039985     EISSN: 15432165     Source Type: Journal    
DOI: 10.5858/arpa.2013-0610-CP     Document Type: Article

References (59)

1. US Department of Health and Human Services. Clinical laboratory improvement amendments of 1988: final rule. Fed Regist. 1992;57(40):7001-7186. Codified at 42 CFR §1405-494.
2. Immunology Branch, Division of Clinical Laboratory Devices, Office of Device Evaluation. 3.9: Manufacturers' recommendations for verification of IHC performance by the user. In: Guidance for Submission of Immunohistochemistry Applications to the FDA. Center for Devices and Radiological Health, US Food and Drug Administration; 1998. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094015.pdf. Accessed September 1, 2013.
3. College of American Pathologists. CAP Laboratory accreditation checklists. http://www.cap.org/apps/cap.portal. Accessed September 1, 2013.
4. Hardy LB, Fitzgibbons PL, Goldsmith JD, et al. Immunohistochemistry validation procedures and practices: a College of American Pathologists survey of 727 laboratories. Arch Pathol Lab Med. 2013;137(1):19-25.
5. Nakhleh RE, Grimm EE, Idowu MO, Souers RJ, Fitzgibbons PL. Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories. Arch Pathol Lab Med. 2010;134(5):728-734.
6. Teutsch SM, Bradley LA, Palomaki GE, et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Initiative: methods of the EGAPP Working Group. Genet Med. 2009;11(1):3-14.
7. US Department of Health and Human Services. Medicare, Medicaid and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988: final rule. Fed Regist. 1992;57:7002-7186.
8. Clinical Laboratory Standards Institute. Quality assurance for design control and implementation of immunohistochemistry assays: approved guideline, second edition. In: CLSI Document I/LA28-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.
9. Dowsett M, Hanna WM, Kockx M, et al. Standardization of HER2 testing: results of an international proficiency-testing ring study. Mod Pathol. 2007;20(5):584-591.
10. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43.
11. Allred DC, Carlson RW, Berry DA, et al. NCCN Task Force report: estrogen receptor and progesterone receptor testing in breast cancer by immunohistochemistry. J Natl Compr Canc Netw [quiz in J Natl Compr Canc Netw. 2009;7(suppl 6):S22-S23]. 2009;7(suppl 6):S1-S21.
12. Baba K, Dyrhol-Riise AM, Sviland L, et al. Rapid and specific diagnosis of tuberculous pleuritis with immunohistochemistry by detecting Mycobacterium tuberculosis complex specific antigen MPT64 in patients from a HIV endemic area. Appl Immunohistochem Mol Morphol. 2008;16(6):554-561.
13. Boers JE, Meeuwissen H, Methorst N. HER2 status in gastro-oesophageal adenocarcinomas assessed by two rabbit monoclonal antibodies (SP3 and 4B5) and two in situ hybridization methods (FISH and SISH). Histopathology. 2011;58(3):383-394.
14. Mayr D, Heim S, Werhan C, Zeindl-Eberhart E, Kirchner T. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest (Dako) for manual testing and Her-2/neuTest 4B5 (Ventana) for Ventana BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Arch. 2009;454(3):241-248.
15. Moelans CB, Kibbelaar RE, van den Heuvel MC, Castigliego D, de Weger RA, van Diest PJ. Validation of a fully automated HER2 staining kit in breast cancer. Cell Oncol. 2010;32(1-2):149-155.
16. O'Grady A, Allen D, Happerfield L, et al. An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines. Appl Immunohistochem Mol Morphol. 2010;18(6):489-493.
17. Phillips T, Murray G, Wakamiya K, et al. Development of standard estrogen and progesterone receptor immunohistochemical assays for selection of patients for antihormonal therapy. Appl Immunohistochem Mol Morphol. 2007;15(3):325-331.
18. Rhodes A, Jasani B, Anderson E, Dodson AR, Balaton AJ. Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries. Am J Clin Pathol. 2002;118(3):408-417.
19. van der Vegt B, de Bock GH, Bart J, Zwartjes NG, Wesseling J. Validation of the 4B5 rabbit monoclonal antibody in determining Her2/neu status in breast cancer. Mod Pathol. 2009;22(7):879-886.
20. Dorfman DM, Bui MM, Tubbs RR, et al. The CD117 immunohistochemistry tissue microarray survey for quality assurance and interlaboratory comparison: a College of American Pathologists Cell Markers Committee study. Arch Pathol Lab Med. 2006;130(6):779-782.
21. Jordan RC, Lingen MW, Perez-Ordonez B, et al. Validation of methods for oropharyngeal cancer HPV status determination in US cooperative group trials. Am J Surg Pathol. 2012;36(7):945-954.
22. Lotan TL, Gurel B, Sutcliffe S, et al. PTEN protein loss by immunostaining: analytic validation and prognostic indicator for a high risk surgical cohort of prostate cancer patients. Clin Cancer Res. 2011;17(20):6563-6573.
23. Lehmann-Che J, Amira-Bouhidel F, Turpin E, et al. Immunohistochemical and molecular analyses of HER2 status in breast cancers are highly concordant and complementary approaches. Br J Cancer. 2011;104(11):1739-1746.
24. Fitzgibbons PL, Murphy DA, Hammond ME, Allred DC, Valenstein PN. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Arch Pathol Lab Med. 2010;134(6):930-935.
25. Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010;134(6):907-922.
26. Torlakovic EE, Naresh K, Kremer M, van der Walt J, Hyjek E, Porwit A. Call for a European programme in external quality assurance for bone marrow immunohistochemistry; report of a European Bone Marrow Working Group pilot study. J Clin Pathol. 2009;62(6):547-551.
27. US Department of Health and Human Services. Medical devices: classification/reclassification of immunochemistry reagents and kits. Fed Regist. 1998;63(106):30132-30142. Codified at 21 CFR §864. Doc. No. 94P-0341.
28. Wolff AC, Hammond EH, Hicks DG, 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;138:241-256. doi:10.5858/arpa.2013-0953-SA.
29. Sun F, Bruening W, Erinoff E, Schoelles KM. Addressing Challenges in Genetic Test Evaluation: Evaluation Frameworks and Assessment of Analytic Validity. Methods research report (prepared by the ECRI Institute Evience-Based Practice Center under contract No. HHSA 290-20007-10063-I). Rockville, MD: Agency for Healthcare Research and Quality; June 2011. AHRQ Publication No. 11-EHC048-EF.
30. Ferguson J, Chamberlain P, Cramer HM, Wu HH. ER, PR, and Her2 immunocytochemistry on cell-transferred cytologic smears of primary and metastatic breast carcinomas: a comparison study with formalin-fixed cell blocks and surgical biopsies. Diagn Cytopathol. 2013;41(7):575-581.
31. Gong Y, Symmans WF, Krishnamurthy S, Patel S, Sneige N. Optimal fixation conditions for immunocytochemical analysis of estrogen receptor in cytologic specimens of breast carcinoma. Cancer. 2004;102(1):34-40.
32. Hanley KZ, Birdsong GG, Cohen C, Siddiqui MT. Immunohistochemical detection of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expression in breast carcinomas: comparison on cell block, needle-core, and tissue block preparations. Cancer. 2009;117(4):279-288.
33. Kumar SK, Gupta N, Rajwanshi A, Joshi K, Singh G. Immunochemistry for oestrogen receptor, progesterone receptor and HER2 on cell blocks in primary breast carcinoma. Cytopathology. 2012;23(3):181-186.
34. Nishimura R, Aogi K, Yamamoto T, et al. Usefulness of liquid-based cytology in hormone receptor analysis of breast cancer specimens. Virchows Arch. 2011;458(2):153-158.
35. Pegolo E, Machin P, Riosa F, Bassini A, Deroma L, Di Loreto C. Hormone receptor and human epidermal growth factor receptor 2 status evaluation on ThinPrep specimens from breast carcinoma: correlation with histologic sections determination. Cancer Cytopathol. 2012;120(3):196-205.
36. Shabaik A, Lin G, Peterson M, et al. Reliability of Her2/neu, estrogen receptor, and progesterone receptor testing by immunohistochemistry on cell block of FNA and serous effusions from patients with primary and metastatic breast carcinoma. Diagn Cytopathol. 2011;39(5):328-332.
37. Adegboyega PA, Gokhale S. Effect of decalcification on the immunohistochemical expression of ABH blood group isoantigens. Appl Immunohistochem Mol Morphol. 2003;11(2):194-197.
38. Arber JM, Arber DA, Jenkins KA, Battifora H. Effect of decalcification and fixation in paraffin-section immunohistochemistry. Appl Immunohistochem. 1996;4(4):241-248.
39. Bussolati G, Leonardo E. Technical pitfalls potentially affecting diagnoses in immunohistochemistry. J Clin Pathol. 2008;61(11):1184-1192.
40. Fend F, Tzankov A, Bink K, et al. Modern techniques for the diagnostic evaluation of the trephine bone marrow biopsy: methodological aspects and applications. Prog Histochem Cytochem. 2008;42(4):203-252.
41. Hsi ED. A practical approach for evaluating new antibodies in the clinical immunohistochemistry laboratory. Arch Pathol Lab Med. 2001;125(2):289-294.
42. Wittenburg G, Volkel C, Mai R, Lauer G. Immunohistochemical comparison of differentiation markers on paraffin and plastic embedded human bone samples. J Physiol Pharmacol. 2009;60(suppl 8):43-49.
43. Zustin J, Boddin K, Tsourlakis MC, et al. HER-2/neu analysis in breast cancer bone metastases. J Clin Pathol. 2009;62(6):542-546.
44. Batistatou A, Televantou D, Bobos M, et al. Evaluation of current prognostic and predictive markers in breast cancer: a validation study of tissue microarrays. Anticancer Res. 2013;33(5):2139-2145.
45. Drev P, Grazio SF, Bracko M. Tissue microarrays for routine diagnostic assessment of HER2 status in breast carcinoma. Appl Immunohistochem Mol Morphol. 2008;16(2):179-184.
46. Fons G, Hasibuan SM, van der Velden J, ten Kate FJ. Validation of tissue microarray technology in endometrioid cancer of the endometrium. J Clin Pathol. 2007;60(5):500-503.
47. Graham AD, Faratian D, Rae F, Thomas JSJ. Tissue microarray technology in the routine assessment of HER-2 status in invasive breast cancer: a prospective study of the use of immunohistochemistry and fluorescence in situ hybridization. Histopathology. 2008;52:847-855.
48. Gulbahce HE, Gamez R, Dvorak L, Forster C, Varghese L. Concordance between tissue microarray and whole-section estrogen receptor expression and intratumoral heterogeneity. Appl Immunohistochem Mol Morphol. 2012;20:340-343.
49. Henriksen KL, Rasmussen BB, Lykkesfeldt AE, Moller S, Ejlertsen B, Mouridsen HT. Semi-quantitative scoring of potentially predictive markers for endocrine treatment of breast cancer: a comparison between whole sections and tissue microarrays. J Clin Pathol. 2007;60(4):397-404.
50. Jones S, Prasad ML. Comparative evaluation of high-throughput small-core (0.6-mm) and large-core (2-mm) thyroid tissue microarray: is larger better? Arch Pathol Lab Med. 2012;136(2):199-203.
51. Kwon MJ, Nam ES, Cho SJ, et al. Comparison of tissue microarray and full section in immunohistochemistry of gastrointestinal stromal tumors. Pathol Int. 2009;59(12):851-856.
52. Nofech-Mozes S, Vella ET, Dhesy-Thind S, et al. Systematic review on hormone receptor testing in breast cancer. Appl Immunohistochem Mol Morphol. 2012;20(3):214-263.
53. Soiland H, Skaland I, van Diermen B, et al. Androgen receptor determination in breast cancer: a comparison of the dextran-coated charcoal method and quantitative immunohistochemical analysis. Appl Immunohistochem Mol Morphol. 2008;16(4):362-370.
54. Thomson TA, Zhou C, Chu C, Knight B. Tissue microarray for routine analysis of breast biomarkers in the clinical laboratory. Am J Clin Pathol. 2009;132(6):899-905.
55. Warnberg F, Amini RM, Goldman M, Jirstrom K. Quality aspects of the tissue microarray technique in a population-based cohort with ductal carcinoma in situ of the breast. Histopathology. 2008;53(6):642-649.
56. Comperat E, Zhang F, Perrotin C, et al. Variable sensitivity and specificity of TTF-1 antibodies in lung metastatic adenocarcinoma of colorectal origin. Mod Pathol. 2005;18(10):1371-1376.
57. Kristensen MH, Nielsen S, Vyberg M. Thyroid transcription factor-1 in primary CNS tumors. Appl Immunohistochem Mol Morphol. 2011;19(5):437-443.
58. Zhang PJ, Gao HG, Pasha TL, Litzky L, Livolsi VA. TTF-1 expression in ovarian and uterine epithelial neoplasia and its potential significance, an immunohistochemical assessment with multiple monoclonal antibodies and different secondary detection systems. Int J Gynecol Pathol. 2009;28(1):10-18.
59. Borrisholt M, Nielsen S, Vyberg M. Demonstration of CDX2 is highly antibody dependant. Appl Immunohistochem Mol Morphol. 2013;21(1):64-72.