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Archives of Pathology & Laboratory... Dec 2016- ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced...
HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology.
CONTEXT
- ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA.
OBJECTIVES
- To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making.
DESIGN
- The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA.
RESULTS
- The panel is proposing 11 recommendations with strong agreement from the open-comment participants.
RECOMMENDATIONS
- The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance.
CONCLUSIONS
- This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.
Topics: Humans; Adenocarcinoma; Biomarkers, Tumor; Clinical Decision-Making; Combined Modality Therapy; Decision Trees; Diagnosis, Differential; Esophageal Neoplasms; Evidence-Based Medicine; Medical Oncology; Molecular Diagnostic Techniques; Molecular Targeted Therapy; Mutation; Neoplasm Grading; Neoplasm Staging; Pathology, Clinical; Receptor, ErbB-2; Societies, Medical; Stomach Neoplasms; United States; Systematic Reviews as Topic
PubMed: 27841667
DOI: 10.5858/arpa.2016-0331-CP -
Dermatology Practical & Conceptual Jan 2014Maintaining patient identity throughout the biopsy pathway is critical for the practice of dermatology and dermatopathology. From the biopsy procedure to the acquisition... (Review)
Review
Maintaining patient identity throughout the biopsy pathway is critical for the practice of dermatology and dermatopathology. From the biopsy procedure to the acquisition of the pathology report, a specimen may pass through the hands of more than twenty individuals in several workplaces. The risk of a mix-up is considerable and may account for more serious mistakes than diagnostic errors. To prevent specimen mix-up, work processes should be standardized and automated wherever possible, e.g., by strict order in the operating room and in the laboratory and by adoption of a bar code system to identify specimens and corresponding request forms. Mutual control of clinicians, technicians, histopathologists, and secretaries, both simultaneously and downstream, is essential to detect errors. The most vulnerable steps of the biopsy pathway, namely, labeling of specimens and request forms and accessioning of biopsy specimens in the laboratory, should be carried out by two persons simultaneously. In preceding work steps, clues must be provided that allow a mix-up to be detected later on, such as information about clinical diagnosis, biopsy technique, and biopsy site by the clinician, and a sketch of the specimen by the technician grossing it. Awareness of the danger of specimen mix-up is essential for preventing and detecting it. The awareness can be heightened by documentation of any error in the biopsy pathway. In case of suspicion, a mix-up of specimens from different patients can be confirmed by DNA analysis.
PubMed: 24520511
DOI: 10.5826/dpc.0401a04 -
Cancer Cytopathology Mar 2015Biospecimen repositories are important for the advancement of biomedical research. Literature on the potential for biobanking of fine-needle aspiration, gynecologic, and... (Review)
Review
Biospecimen repositories are important for the advancement of biomedical research. Literature on the potential for biobanking of fine-needle aspiration, gynecologic, and nongynecologic cytology specimens is very limited. The potential for biobanking of these specimens as valuable additional resources to surgically excised tissues appears to be excellent. The cervicovaginal specimens that can be used for biobanking include Papanicolaou-stained monolayer preparations and residual material from liquid-based cytology preparations. Different types of specimen preparations of fine-needle aspiration and nongynecologic specimens, including Papanicolaou-stained and Diff-Quik-stained smears, cell blocks. and dedicated passes/residual material from fine-needle aspiration stored frozen in a variety of solutions, can be used for biobanking. Because of several gaps in knowledge regarding the standard of operative procedures for the procurement, storage, and quality assessment of cytology specimens, further studies as well as national conferences and workshops are needed not only to create awareness but also to facilitate the use of cytopathology specimens for biobanking.
Topics: Biological Specimen Banks; Cytodiagnosis; Humans; Pathology, Clinical
PubMed: 25524469
DOI: 10.1002/cncy.21505 -
The British Journal of Radiology May 2022The purpose of this article is to review the technical and radiological aspects of MagSeed localisation, to assess its accuracy based on post-localisation mammograms and... (Review)
Review
OBJECTIVES
The purpose of this article is to review the technical and radiological aspects of MagSeed localisation, to assess its accuracy based on post-localisation mammograms and excision specimen X-rays and to discuss the radiological experience of our institutions.
METHODS
Two-year data were collected retrospectively from three NHS boards from the West of Scotland. A total of 309 MagSeeds were inserted under mammographic or ultrasonographic guidance in 300 women with unifocal, multifocal and/or bilateral breast lesions at the day of surgery or up to 30 days prior to it. Radiological review of post-localisation mammograms and intraoperative specimen X-rays as well as a review of the surgical outcomes were performed to assess the accuracy and efficacy of the method. Our experience relating to the technique's strengths and downsides were also noted.
RESULTS
The MagSeeds were inserted on average 7.2 days before surgery. The localisation technique was straight forward for the radiologists. In 99% of the cases, the MagSeed was successfully deployed and 100% of the successfully localised lesions were excised at surgery. There was no difference in the accuracy of the localisation whether this was mammographically or ultrasonographically guided. On post-localisation mammograms, the MagSeed was radiologically accurately positioned in 97.3% of the cases. No delayed MagSeed migration was observed. On the specimen X-rays, the lesion was centrally positioned in 45.1%, eccentric within more than 1 mm from the margin in 35.7% and in 14.8% it was at the specimen's margin. The re-excision rate was 18.3%.
CONCLUSION
The MagSeed is an accurate and reliable localisation method in breast conserving surgery with good surgical outcomes.
ADVANCES IN KNOWLEDGE
To our knowledge, the radiological aspects of MagSeed localisation have not been widely described in peer-reviewed journals thus far.
Topics: Breast; Breast Neoplasms; Female; Humans; Male; Mammography; Margins of Excision; Radiography; Retrospective Studies
PubMed: 35201906
DOI: 10.1259/bjr.20211241 -
Methods in Enzymology 2016Imaging a material with electrons at near-atomic resolution requires a thin specimen that is stable in the vacuum of the transmission electron microscope. For biological... (Review)
Review
Imaging a material with electrons at near-atomic resolution requires a thin specimen that is stable in the vacuum of the transmission electron microscope. For biological samples, this comprises a thin layer of frozen aqueous solution containing the biomolecular complex of interest. The process of preparing a high-quality specimen is often the limiting step in the determination of structures by single-particle electron cryomicroscopy (cryo-EM). Here, we describe a systematic approach for going from a purified biomolecular complex in aqueous solution to high-resolution electron micrographs that are suitable for 3D structure determination. This includes a series of protocols for the preparation of vitrified specimens on various supports, including all-gold and graphene. We also describe techniques for troubleshooting when a preparation fails to yield suitable specimens, and common mistakes to avoid during each part of the process. Finally, we include recommendations for obtaining the highest quality micrographs from prepared specimens with current microscope, detector, and support technology.
Topics: Cryoelectron Microscopy; Equipment Design; Gold; Graphite; Humans; Image Processing, Computer-Assisted; Proteins; Specimen Handling; Staining and Labeling; Vitrification
PubMed: 27572723
DOI: 10.1016/bs.mie.2016.04.011 -
Health Security Jan 2020Efficient specimen transport systems are critical for early disease detection and reporting by laboratory networks. In Burkina Faso, centralized reference laboratories...
Efficient specimen transport systems are critical for early disease detection and reporting by laboratory networks. In Burkina Faso, centralized reference laboratories receive specimens from multiple surveillance sites for testing, but transport methods vary, resulting in potential delays and risk to specimen quality. The ministry of health and partners, under the Global Health Security Agenda implementation, piloted a specimen transport system for severe acute respiratory illness (SARI) surveillance in 4 Burkina Faso districts. A baseline assessment was conducted of the current specimen transport network structure and key stakeholders. Assessment results and guidelines for processing SARI specimens informed the pilot specimen transport system design and implementation. Monitoring and evaluation performance indicators included: proportion of packages delivered, timeliness, and quality of courier services (missed or damaged packages). Our baseline assessment found that laboratorians routinely carried specimens from the health center to reference laboratories, resulting in time away from laboratory duties and potential specimen delays or loss of quality. The pilot specimen transport system design engaged Sonapost, the national postal service, to transport specimens from SARI sites to the influenza national reference laboratory. From May 2017 to December 2018, the specimen transport system transported 557 packages containing 1,158 SARI specimens; 95% (529/557) were delivered within 24 hours of pick-up and 77% (892/1,158) within 48 hours of collection. No packages were lost. This article highlights lessons learned that may be useful for other countries considering establishment of a specimen transport system to strengthen laboratory system infrastructure in global health security implementation.
Topics: Burkina Faso; Epidemiological Monitoring; Humans; Postal Service; Respiratory Tract Infections; Specimen Handling; Time Factors; Transportation
PubMed: 32004130
DOI: 10.1089/hs.2019.0068 -
BME Frontiers 2021. We propose a rapid and accurate blood cell identification method exploiting deep learning and label-free refractive index (RI) tomography. Our computational approach...
. We propose a rapid and accurate blood cell identification method exploiting deep learning and label-free refractive index (RI) tomography. Our computational approach that fully utilizes tomographic information of bone marrow (BM) white blood cell (WBC) enables us to not only classify the blood cells with deep learning but also quantitatively study their morphological and biochemical properties for hematology research. . Conventional methods for examining blood cells, such as blood smear analysis by medical professionals and fluorescence-activated cell sorting, require significant time, costs, and domain knowledge that could affect test results. While label-free imaging techniques that use a specimen's intrinsic contrast (e.g., multiphoton and Raman microscopy) have been used to characterize blood cells, their imaging procedures and instrumentations are relatively time-consuming and complex. . The RI tomograms of the BM WBCs are acquired via Mach-Zehnder interferometer-based tomographic microscope and classified by a 3D convolutional neural network. We test our deep learning classifier for the four types of bone marrow WBC collected from healthy donors (): monocyte, myelocyte, B lymphocyte, and T lymphocyte. The quantitative parameters of WBC are directly obtained from the tomograms. . Our results show >99% accuracy for the binary classification of myeloids and lymphoids and >96% accuracy for the four-type classification of B and T lymphocytes, monocyte, and myelocytes. The feature learning capability of our approach is visualized via an unsupervised dimension reduction technique. . We envision that the proposed cell classification framework can be easily integrated into existing blood cell investigation workflows, providing cost-effective and rapid diagnosis for hematologic malignancy.
PubMed: 37849908
DOI: 10.34133/2021/9893804 -
American Journal of Physical... May 2021We investigated the diversity of the pygmy marmoset, Cebuella pygmaea, by comparing genetic, morphological and pelage traits of animals from Peru and Ecuador.
OBJECTIVES
We investigated the diversity of the pygmy marmoset, Cebuella pygmaea, by comparing genetic, morphological and pelage traits of animals from Peru and Ecuador.
MATERIALS AND METHODS
We extracted DNA from museum specimen osteocrusts and from fecal samples collected from free-ranging individuals. We sequenced the mtDNA cytochrome b gene and the control region from samples collected at 13 different sites and used Bayesian inference and Maximum Likelihood to identify distinct clades. We took measurements of the crania of a subset of these specimens (n = 26) and ran a logistic regression to determine if any of the cranial measurements (n = 22) could predict a specimen's clade. In addition, we examined the pelage patterns of the museum specimens and photographs taken of free-ranging individuals and divided them into pelage types based on coloration of the underbelly.
RESULTS
We identified two divergent clades, and two distinct groups with clear geographic boundaries within one of those clades. Two measurements of the zygomatic bone perfectly predicted a given individual's mtDNA clade. We found four distinct pelage patterns in our samples, but these patterns are variable within clades and among individuals within the same population.
CONCLUSION
These analyses indicate that the two recognized subspecies of pygmy marmoset should be elevated to the species level (C. pygmaea and C. niveiventris) based on molecular and cranial differences but not on pelage patterns. We provide evidence on the geographic limits of the two clades and identify regions where additional sampling is required to better define the geographic distribution of the two clades.
Topics: Animals; Animals, Wild; Anthropology, Physical; Callitrichinae; DNA, Mitochondrial; Ecuador; Female; Male; Museums; Peru; Phylogeny; Skull
PubMed: 33751563
DOI: 10.1002/ajpa.24266 -
Materials (Basel, Switzerland) Sep 2022Electron backscatter diffraction (EBSD) has been used for more than 30 years for analyzing the structure of minerals and artificial substances. In recent times, EBSD has... (Review)
Review
Electron backscatter diffraction (EBSD) has been used for more than 30 years for analyzing the structure of minerals and artificial substances. In recent times, EBSD has been widely applied for investigation of irradiated nuclear fuel and matrices for the immobilization of radioactive waste. The combination of EBSD and scanning electron microscopy (SEM/EDS) methods allows researchers to obtain simultaneously data on a specimen's local composition and structure. The article discusses the abilities of SEM/EDS and EBSD techniques to identify zirconolite polytype modifications and members of the polysomatic murataite-pyrochlore series in polyphase ceramic matrices, with simulations of Pu (Th) and the REE-actinide fraction (Nd) of high-level radioactive waste.
PubMed: 36079472
DOI: 10.3390/ma15176091 -
Archives of Pathology & Laboratory... Feb 2020Synthetic urine products are commercially marketed for the purpose of specimen substitution for urine drug screens. These products are widely popular because they yield...
CONTEXT.—
Synthetic urine products are commercially marketed for the purpose of specimen substitution for urine drug screens. These products are widely popular because they yield negative drug screen results, meet criteria for specimen validity testing, and are easily accessible and affordable. Current specimen validity criteria are ineffective for detecting these synthetic products, and new markers of specimen validity are required.
OBJECTIVE.—
To develop and evaluate a multicomponent liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for urine specimen validity testing.
DESIGN.—
A quantitative LC-MS/MS assay was developed for caffeine, cotinine, theobromine, and urobilin in urine. The assay was applied to known synthetic urine products (n = 10) as well as human specimens received for pre-employment testing (n = 500), for-cause workplace testing (n = 100), and medical pain management monitoring (n = 200). Specimens devoid of all 4 validity markers were subjected to follow-up testing that involved microscopic urinalysis and comprehensive gas chromatography mass spectrometry for drugs, pharmaceuticals, hormones, and lipids.
RESULTS.—
Of the experimental groups, 10 of 10 synthetic urine products (100%), 12 of 500 pre-employment specimens (2.4%), and 4 of 200 pain management specimens (2.0%) failed the experimental LC-MS/MS assay. Follow-up testing indicated that each of the failed specimens was nonphysiologic in nature.
CONCLUSIONS.—
Simultaneous application of the 4 experimental validity markers appeared to be a robust method for detecting nonphysiologic specimens. New markers of specimen validity must be developed in order to identify commercially available synthetic urine products.
Topics: Biomarkers; Caffeine; Chromatography, Liquid; Cotinine; Humans; Substance Abuse Detection; Tandem Mass Spectrometry; Theobromine; Urinalysis; Urobilin
PubMed: 31755779
DOI: 10.5858/arpa.2019-0197-OA