Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories

Stuart, Lauren N.; Volmar, Keith E.; Nowak, Jan A.; Fatheree, Lisa A.; Souers, Rhona J.; Fitzgibbons, Patrick L.; Goldsmith, Jeffrey D.; Astles, J. Rex; Nakhleh, Raouf E.

doi:10.5858/arpa.2016-0559-cp

Cited by 13 publications

(16 citation statements)

References 12 publications

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“…Because of the clinical importance of predictive biomarkers, the College of American Pathologists guidelines for validation of these biomarkers are more stringent than those for other stains. 39…”

Section: Molecular and Biomarker Testing In Effusion Specimensmentioning

confidence: 99%

“…If PD‐L1 is reported in lower cellularity specimens, an explanatory note should indicate that the interpretation might be limited by the low cellularity. Because of the clinical importance of predictive biomarkers, the College of American Pathologists guidelines for validation of these biomarkers are more stringent than those for other stains …”

Section: Introductionmentioning

confidence: 99%

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Ancillary studies in pleural, pericardial, and peritoneal effusion cytology

Sundling¹,

Cibas

2018

Cancer Cytopathology

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Pleural, pericardial, and peritoneal effusion specimens present diagnostic challenges and clinical opportunities for cytology. For the patient, these specimens may be the first diagnosis of malignancy or the first sign of disease recurrence. This review aims to provide useful approaches with which to resolve key difficulties in cytologic diagnosis through the use of ancillary studies, focusing on immunohistochemistry. These approaches are suggested in concert with clinical, radiographic, and morphologic findings. The differentiation of reactive mesothelial cells from malignant mesothelioma and adenocarcinoma is a recurring theme, and Wilms tumor 1 (WT1)/AE1/AE3, claudin 4, and BRCA1-associated protein 1 (BAP1) immunostains are useful new tools in the armamentarium. A targeted workup is suggested for patients with no known primary site or with multiple prior malignancies. Molecular and other biomarker testing can be performed on even modestly cellular fluid specimens and may allow patients to benefit from targeted therapy without the need for additional tissue biopsies. Cancer Cytopathol 2018;000:000-000. © 2018 American Cancer Society.

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Section: Molecular and Biomarker Testing In Effusion Specimensmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Ancillary studies in pleural, pericardial, and peritoneal effusion cytology

Sundling¹,

Cibas

2018

Cancer Cytopathology

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“…The wide array of different cytology substrates on which immunohistochemistry can be performed can be a challenge to validation, with less than half of surveyed laboratories adjusting staining conditions or having different validation protocols for cytology versus surgical pathology specimens. 7,8 Likewise, many molecular and cytogenetic tests are validated on FFPE materials, and most reference laboratories will only perform testing on cytology specimens if in the form of a cell block and not direct smears, which has important implications on how cytologic material is collected (if at all) at the time of biopsy. 9 Cytology laboratories may have much more flexibility with specimen collection and processing methods when using in-house molecular testing.…”

Section: Specimen Processingmentioning

confidence: 99%

Pre‐analytic error: A significant patient safety risk

Heher

Chen

VanderLaan

2018

Cancer Cytopathology

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Ancillary testing in cytopathology has grown dramatically over the past decade, enhancing the clinical value of cytology specimens obtained via minimally invasive methods. However, a complex testing landscape brings with it new and emerging risks to patient safety. Recognition of complicated systems issues as well as shared responsibility in process ownership can help to minimize safety risks. Because pre-analytic factors account for the majority of errors in pathology, attention to operational steps (test ordering, specimen collection, specimen transport, specimen accessioning, and specimen processing) is critical for successful quality improvement programs. With increasing technical costs and complexity of many ancillary molecular tests, a growing trend toward send-out testing to centralized reference laboratories poses additional patient safety risks. Given these new realities in cytopathology ancillary testing, a collaborative, team-based approach with all process stakeholders is needed to improve pre-analytic processes, reduce error risk, and enhance patient safety.

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“…These results included 1539 of 3064 surveys (50%) from laboratories participating in the CAP PT programs and 85 of 448 surveys (19%) from the nonparticipant laboratories. The quantitative IHC VAL survey results were tabulated, analyzed for comparison, and published separately by Fitzgibbons et al 9 In addition, Stuart et al 10 were able to publish new immunohistochemical validation benchmark data for laboratories.…”

Section: Al Guidelinementioning

confidence: 99%

Evaluating the Adoption of Laboratory Practice Guidelines

Goldsmith

Fitzgibbons

Fatheree

et al. 2019

Archives of Pathology &Amp; Laboratory Medicine

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Context.— To date, the College of American Pathologists (CAP) has developed 17 laboratory practice guidelines (LPGs) including updates. In 2013, the CAP was awarded a 5-year cooperative agreement grant from the United States Centers for Disease Control and Prevention to increase the effectiveness of LPGs. Objective.— To assess the awareness and adoption of 2 CAP LPGs: immunohistochemical (IHC) assay validation and initial workup of acute leukemia. Design.— Baseline surveys for each LPG were conducted in 2010 and 2015, respectively. To measure the adoption of guideline recommendations and inform future updates, a follow-up study consisting of surveys, telephone interviews, and focus group sessions was conducted in laboratories that indicated they perform IHC testing. A follow-up study for the acute leukemia LPG is planned. Results.— For the IHC Validation LPG, a total of 1624 survey responses, 40 telephone interviews, and discussions with 5 focus group participants were analyzed. The response rate for the aforementioned 3 modalities was 46%, 13%, and 3%, respectively. All modalities indicated most respondents were aware of the LPG and had adopted most or all of its recommendations. Respondents expressed needs for continued communication, increased specificity, and more prescriptive recommendations when the guideline is updated. Conclusions.— While data-driven development of evidence-based LPGs requires significant resources, active data collection to identify gaps and assess adoption contributes to improved laboratory testing practices in support of patient care. The CAP identified sustainable modalities to track metrics and developed multiple tools that should improve guideline development, adoption, and implementation. Of these modalities, written or electronic surveys were the most logistically feasible and had the highest response rate.

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Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories

Abstract: - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

Cited by 13 publications

References 12 publications

Ancillary studies in pleural, pericardial, and peritoneal effusion cytology

Ancillary studies in pleural, pericardial, and peritoneal effusion cytology

Pre‐analytic error: A significant patient safety risk

Evaluating the Adoption of Laboratory Practice Guidelines

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