Immunohistochemistry Validation Procedures and Practices: A College of American Pathologists Survey of 727 Laboratories

Hardy, Lindsay; Fitzgibbons, Patrick L.; Goldsmith, Jeffery D.; Eisen, Richard N.; Beasley, Mary Beth; Souers, Rhona J.; Nakhleh, Raouf E.

doi:10.5858/arpa.2011-0676-cp

Cited by 44 publications

(32 citation statements)

References 8 publications

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“…26 Unfortunately, a number of laboratories do not validate new antibodies according to validation standards. 27 In the present paper, we provide a validation for EP1 antibody clone in ER testing by IHC performed by the Pathology Service of the St-Sacrement Hospital, which is a breast cancer reference center in the Province of Quebec, Canada, according to recognized validation standards for ER testing. 20,24 Our results showed an excellent agreement between the previously used antibody clone (SP1) and the new EP1 antibody clone for ER status assessment in breast cancer using Dako autostaining technologies.…”

Section: Discussionmentioning

confidence: 99%

Validation of EP1 Antibody Clone for Estrogen Receptor Immunohistochemistry in Breast Cancer

Diorio

Laberge²,

Caron³

et al. 2014

Applied Immunohistochemistry &Amp; Molecular Morphology

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Estrogen receptor (ER) tumor's status is critical for breast cancer management. A new rabbit antibody clone, EP1, is now available for ER status determination. The objective was to validate the EP1 antibody clone for its use in breast cancer ER status determination in a clinical setting against the previous standard, SP1. EP1 clone was assessed in 130 consecutive cases, including 50 ER-negative (<1% ER expression), 13 ER-low-positive (1% to 9% ER expression), and 67 ER-positive (≥10% ER expression). Using EP1 versus SP1, positive agreement (sensibility) was 92.5% and negative agreement (specificity) was 100%, leading to an overall agreement of 95.4%. All discordant cases (n=6) were ER-low-positive. SP1 was remeasured in 13 ER-low-positive and in 11 ER-negative cases. Overall agreement between SP1 initial tumor status and reassessment was 70.8% in those negative and low-positive cases. In conclusion, EP1 antibody has been validated for use in breast cancer with a positive agreement ≥90% and a negative agreement ≥95%, as recommended. Also, overall agreement between EP1 and SP1 was as good as between the SP1 initial status and SP1 reassessment.

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Section: Discussionmentioning

confidence: 99%

Validation of EP1 Antibody Clone for Estrogen Receptor Immunohistochemistry in Breast Cancer

Diorio

Laberge²,

Caron³

et al. 2014

Applied Immunohistochemistry &Amp; Molecular Morphology

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“…Tables 2 and 3 display the results for the correlation between the immunocytochemical and immunohistochemical techniques in the leukoplakia and squamous cell carcinoma groups, indicating nonstatistically significant agreement. 12 This is the first study to assess the expression of adhesion (E-cadherin) and cell differentiation (involucrin) markers in exfoliated oral mucosal cells from leukoplakia and squamous cell carcinoma lesions using immunocytochemistry. In addition, the findings of the immunocytochemical and immunohistochemical analyses were correlated by using these markers in patients with the lesions described above.…”

Section: Resultsmentioning

confidence: 99%

Expression of E-cadherin and involucrin in leukoplakia and oral cancer: an immunocytochemical and immunohistochemical study

et al. 2017

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To assess the immunocytochemical and immunohistochemical correlation of adhesion (E-cadherin) and cell differentiation (involucrin) molecules in oral leukoplakia and oral squamous cell carcinoma. Cytological samples and biopsies were obtained from male and female patients aged over 30 years with oral leukoplakia (n = 30) and oral squamous cell carcinoma (n = 22). Cell scrapings and the biopsy were performed at the site of the lesion and histological slides were prepared for the immunocytochemical analysis of exfoliated oral mucosal cells and for the immunohistochemical analysis of biopsy tissues using E-cadherin and involucrin. Spearman's correlation and kappa coefficients were used to assess the correlation and level of agreement between the techniques. Immunostaining for E-cadherin and involucrin by both techniques was similar in the superficial layers of the histological sections compared with cell scrapings. However, there was no statistical correlation and agreement regarding the immunocytochemical and immunohistochemical expression of E-cadherin and involucrin in oral leukoplakia (R = 0.01, p = 0.958) (Kappa = 0.017, p = 0.92) or in oral squamous cell carcinoma (R = 0.26, p = 0.206) (Kappa = 0.36, p = 0.07). The immunoexpression of E-cadherin and involucrin in tissues is consistent with the expression patterns observed in exfoliated oral mucosal cells, despite the lack of a statistically significant correlation. There is an association of the histopathological characteristics of leukoplakia with the expression E-cadherin and of the microscopic aspects of oral squamous cell carcinoma with immunohistochemical expression of involucrin.

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“…3,4 Given this inherent variability, there have been efforts to standardize these tests, and the US Food and Drug Administration, American Society of Clinical Oncology, and College of American Pathologists (CAP) have each provided special direction on some testing (eg, human epidermal growth factor 2 [HER2/neu]). 5,6 Whole slide imaging (WSI) with algorithmic analysis is one potential technology to improve the assessment of such markers (as shown in the Table). This has ranged from studies on basic H&E slides to IHC to multiparametric quantum dot staining.…”

mentioning

confidence: 99%

Whole Slide Imaging for Analytical Anatomic Pathology and Telepathology: Practical Applications Today, Promises, and Perils

Farris¹,

Cohen²,

Rogers³

et al. 2017

Archives of Pathology &Amp; Laboratory Medicine

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Whole slide imaging (WSI) offers a convenient, tractable platform for measuring features of routine and special-stain histology or in immunohistochemistry staining by using digital image analysis (IA). We now routinely use IA for quantitative and qualitative analysis of theranostic markers such as human epidermal growth factor 2 (HER2/neu), estrogen and progesterone receptors, and Ki-67. Quantitative IA requires extensive validation, however, and may not always be the best approach, with pancreatic neuroendocrine tumors being one example in which a semiautomated approach may be preferable for patient care. We find that IA has great utility for objective assessment of gastrointestinal tract dysplasia, microvessel density in hepatocellular carcinoma, hepatic fibrosis and steatosis, renal fibrosis, and general quality analysis/quality control, although the applications of these to daily practice are still in development. Collaborations with bioinformatics specialists have explored novel applications to gliomas, including in silico approaches for mining histologic data and correlating with molecular and radiologic findings. We and many others are using WSI for rapid, remote-access slide reviews (telepathology), though technical factors currently limit its utility for routine, high-volume diagnostics. In our experience, the greatest current practical impact of WSI lies in facilitating long-term storage and retrieval of images while obviating the need to keep slides on site. Once the existing barriers of capital cost, validation, operator training, software design, and storage/back-up concerns are overcome, these technologies appear destined to be a cornerstone of precision medicine and personalized patient care, and to become a routine part of pathology practice.

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Immunohistochemistry Validation Procedures and Practices: A College of American Pathologists Survey of 727 Laboratories

Cited by 44 publications

References 8 publications

Validation of EP1 Antibody Clone for Estrogen Receptor Immunohistochemistry in Breast Cancer

Validation of EP1 Antibody Clone for Estrogen Receptor Immunohistochemistry in Breast Cancer

Expression of E-cadherin and involucrin in leukoplakia and oral cancer: an immunocytochemical and immunohistochemical study

Whole Slide Imaging for Analytical Anatomic Pathology and Telepathology: Practical Applications Today, Promises, and Perils

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