Analytic inquiry: Validation and practical considerations

Berry, Anna B.

doi:10.1002/cncy.21871

Cited by 4 publications

(8 citation statements)

References 27 publications

(24 reference statements)

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“…Similar to surgical specimens, cell blocks may suffer from formalin fixation effects that decrease accuracy. Cell block samples are less tolerant of excess formalin fixation times due to their very small size 10 . Fixation artifacts and epitope retrieval protocols can cause fragmentation of nucleic acids which decrease the amount of amplifiable DNA.…”

Section: Pre‐analytic Considerationsmentioning

confidence: 99%

“…Tests on stained slides may have contaminants carried over from staining solutions which may be reused multiple times. 10 Contamination may be minimised by changing the solutions regularly and after staining very cellular/ friable samples. Fixation in either formalin or alcohol does not appear to interfere with the performance of ISH for the most relevant predictive markers in lung cancer, namely ALK rearrangement, ROS1 rearrangement, and MET amplification.…”

Section: Analy Ticandp Os T-analy Tic (Interpre Tive )Con S Ider Ati ...mentioning

confidence: 99%

“…Thus, cell block remains the main type of cytological specimen used for molecular testing 8 . Several guidelines and examples have been published regarding the validation of IPOX and molecular tests on cytology specimens 9–14 . Rigorous validation studies are required before clinical implementation of molecular testing on non‐FFPE cytology preparations 1,8,15 …”

Section: Introductionmentioning

confidence: 99%

“…Cell block samples are less tolerant of excess formalin fixation times due to their very small size. 10 Fixation artifacts and epitope retrieval protocols can cause fragmentation of nucleic acids which decrease the amount of amplifiable DNA. Deamination leading to C:G > T:A transitions, which is the most common type of formalin artifact, cause false positive results.…”

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confidence: 99%

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Molecular cytology of the respiratory tract and pleura

2021

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There is growing evidence that molecular testing is feasible on all types of cytological preparation, which is fortunate as more diagnostic markers and biomarkers for targeted therapies are discovered for use in pulmonary and pleural malignancies. In this article we will discuss the pre‐analytic, analytic, and post‐analytic (interpretive) considerations for successful implementation of molecular tests for diagnostic and predictive markers in respiratory and pleural cytology. The vast majority of laboratories are familiar with, and have validated their molecular protocols for, formalin‐fixed paraffin‐embedded surgical specimens, which are not directly applicable to cytology specimens. Thus, rigorous validation must be performed for each type of fixative and cytology preparation before it is implemented in the clinical setting.

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Section: Pre‐analytic Considerationsmentioning

confidence: 99%

Section: Analy Ticandp Os T-analy Tic (Interpre Tive )Con S Ider Ati ...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Molecular cytology of the respiratory tract and pleura

2021

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“…For this approach to be reliable, dependable, and effective, test validation specific to cytology samples is mandatory in the sequence after sample acquisition and optimization. To this end, Dr. Anna Berry, the director of molecular diagnostics at CellNetix and the scientific director of personalized medicine at the Swedish Cancer Institute (Seattle, Wash), discusses test validation and selected issues referable to cytology samples for immunohistochemistry, in situ hybridization, nucleic acid amplification, and gene sequencing techniques . With combined expertise in cytopathology and molecular pathology, Berry's informed approach to these complex and sophisticated analyses provides the perspective required for this supplement to achieve its intent.…”

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confidence: 99%

Cytopathology is the Nexus for patient‐centered care

Powers

Kaminsky²

2017

Cancer Cytopathology

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The genomic revolution has been facilitated by the convergence of minimally invasive diagnostic and therapeutic techniques, refinements in imaging and guided biopsy (particularly fine-needle aspiration biopsy), the development of whole genome sequencing, and the emergence of targeted therapies. Cytopathologists are the first responders from laboratories: they are educated to acquire, triage, and assess small biopsies and cell samples as substrates for molecular testing, next-generation sequencing, fluorescence in situ hybridization, immunohistochemistry, and genetic testing. Pathologists and cytopathologists are now integral to multidisciplinary care teams and have a voice in patient assessments for treatment plans. Cytopathologists who perform fine-needle aspiration biopsy (particularly ultrasound-guided biopsy) are at the direct interface with patients and are, of necessity, developing communication skills that incorporate empathy and compassion.Information transfer in the digital age has been complicated by information overload, a phenomenon that creates an opportunity for cytopathologists to become mentors in making sense of information (the process of information diffusion) and managing overload by serving as information professionals who guide learners to appropriate information resources.As cytopathologists migrate toward the center of patient care through interventional interfaces with patients, we become responsible for generating a complete, integrated report that moves information to patient portals on the Internet and to clinicians by secure digital delivery methods. With 70% of the medical record representing laboratory information, it is critical that pathologists take responsibility for its accuracy, display, and integration.This supplement, The Genomic Revolution: The Critical Role of Cytopathology in Patient-Centered Care and Personalized Medicine, was conceived to unite current research and procedural protocols with real-world clinical processes, from the clinical encounter with the patient to the quality assessment of the final report, and it is intended to provide an in-depth snapshot of why cytopathology is essential and integral to patient-centered care in the genomic era.Dr. Edward J. Gutmann, working in the pathology department of the Dartmouth-Hitchcock Medical Center (Dartmouth's Geisel School of Medicine), addresses caring for the patient in the context of cytopathology: "The diagnoses we make via the conscientious applications of specialized knowledge" represent how we care, and "the right diagnosis communicated well to patient and clinician can light the route even as it establishes it."1 Subliminally permeating his narrative exposition are the compassion and empathy that must characterize interactions with patients and communications with and about them. Caring implies and necessitates a culture of safety with metrics-based analysis of performance variation; root causes; error reporting, detection, and reduction; repair and adverse event management; and general quality initiatives. ...

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Validation of Fluorescence In Situ Hybridization (FISH) for Chromosome 5 Monosomy and Deletion

Zneimer¹

2020

CP Human Genetics

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In order to comply with regulations set by established local, state, and federal agencies and other regulatory organizations, such as the College of American Pathologists and the International Organization for Standardization, a clinical laboratory needs to develop procedures for the processes of validating laboratory‐developed tests (LDTs) and establishing performance specifications for these assays prior to use in clinical testing. This is applicable to all fluorescence in situ hybridization (FISH) assays. Even Food and Drug Administration–approved FISH assays must undergo some form of verification before implementation in the clinical laboratory. The process of validating an assay as an LDT must include a plan, a procedure, and a report. The validation studies described here include metaphase and interphase FISH methodology for identification of the LSI EGR1/D5S23, D5S721 dual‐color probe, which labels distinct biomarkers consistent with myeloid hematologic disorders, including myelodysplasias and acute myeloid leukemia. © 2020 by John Wiley & Sons, Inc. Basic Protocol 1: Validation plan for fluorescence in situ hybridization (FISH) probes for chromosome 5 monosomy and deletion Support Protocol: Normal cut‐off calculation Basic Protocol 2: Validation procedure for FISH probes for chromosome 5 monosomy and deletion Basic Protocol 3: Validation report for FISH probes for chromosome 5 monosomy and deletion

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Analytic inquiry: Validation and practical considerations

Cited by 4 publications

References 27 publications

Molecular cytology of the respiratory tract and pleura

Molecular cytology of the respiratory tract and pleura

Cytopathology is the Nexus for patient‐centered care

Validation of Fluorescence In Situ Hybridization (FISH) for Chromosome 5 Monosomy and Deletion

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