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Clinica Chimica Acta; International... Jun 2022In the current COVID-19 pandemic, early and rapid diagnosis of potentially infected and contagious individuals enables containment of the disease through quarantine and...
BACKGROUND
In the current COVID-19 pandemic, early and rapid diagnosis of potentially infected and contagious individuals enables containment of the disease through quarantine and contact tracing. The rapid global expansion of these diagnostic testing services raises questions concerning the current state of the art with regard to standardization of testing and quality assessment practices. The aim of this study was to provide a global overview of the test methods, laboratory procedures and quality assessment practices used for SARS-CoV-2 diagnostics.
METHODS
The Molecular Diagnostics Committee of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) initiated a survey among international laboratories performing molecular genetic detection of SARS-CoV-2. Questions on quality assurance, variant testing, sequencing and the transmission of findings were included in the survey.
RESULTS
A total of 273 laboratories from 49 countries participated in the survey. The majority of the participating laboratories (92.2%) use reverse transcriptase polymerase chain reaction (RT-PCR). The majority of participating laboratories do not conduct testing to identify SARS CoV-2 variants. Participation in external quality assessment programs was reported by the majority of laboratories, however, 33.2% of the laboratories reported not participating in external quality assurance programmes.
CONCLUSIONS
Based on the survey, molecular diagnostic methods for SARS-CoV-2 detection are clearly not standardized across different countries and laboratories. The survey found an array of responses in regard to sample preparation, collection, processing and reporting of results. This work suggests quality assurance is insufficiently performed by diagnostic laboratories conducting SARS-CoV-2 testing.
Topics: COVID-19; COVID-19 Testing; Humans; Pandemics; Pathology, Molecular; SARS-CoV-2
PubMed: 35413298
DOI: 10.1016/j.cca.2022.04.007 -
Archives of Pathology & Laboratory... Sep 2016-Prior to 1900, laboratory tests were simple enough to be performed by clinicians on the wards and most pathologists were academicians with little involvement in patient... (Review)
Review
CONTEXT
-Prior to 1900, laboratory tests were simple enough to be performed by clinicians on the wards and most pathologists were academicians with little involvement in patient care issues. In the next 2 decades, laboratory test menus expanded rapidly and the increasing complexity of the tests created a potential niche for clinical pathologists (ie, pathologists providing patient-oriented anatomic and clinical pathology services). In the late 1910s and early 1920s, most of these services were provided by mail-order commercial laboratories or state public health laboratories rather than by hospital-based pathologists.
OBJECTIVE
-To describe the political events in the 1920s that would drastically alter the practice of pathology and laboratory medicine and that would have been important to the discipline at the time the Archives of Pathology and Laboratory Medicine was being conceived and first published.
DESIGN
-Available primary and secondary historical sources were reviewed.
RESULTS
-In the 1920s, clinical pathologists organized, forming the American Society of Clinical Pathologists, and took on the powerful American Medical Association for permitting advertisements by private laboratories in the pages of the Journal of the American Medical Association that listed test prices as if these were commodities. They found a strong partner in the American College of Surgeons, which was attempting to elevate surgical practice by creating minimum standards for hospitals. Through this symbiotic relationship, hospital-based practice was firmly established and the commercial laboratory model faltered.
CONCLUSIONS
-The Roaring Twenties was the time when the practice of pathology and laboratory medicine evolved into what we recognize today.
Topics: American Medical Association; Clinical Laboratory Services; Humans; Laboratories, Hospital; Pathologists; Pathology, Clinical; Periodicals as Topic; Politics; Public Health; United States
PubMed: 27139153
DOI: 10.5858/arpa.2016-0113-HP -
Cancer Cytopathology Oct 2021The development of high-throughput drug screening (HTS) using primary cultures provides a promising, clinically translatable approach to tailoring treatment strategies...
BACKGROUND
The development of high-throughput drug screening (HTS) using primary cultures provides a promising, clinically translatable approach to tailoring treatment strategies for patients with cancer. However, this has been challenging for solid tumors because of often limited amounts of tissue available. In most cases, in vitro expansion is required before HTS, which may lead to overgrowth and contamination by non-neoplastic cells.
METHODS
In this study, hematoxylin and eosin staining and immunohistochemical staining were performed on 129 cytopathology cases from 95 patients. These cytopathology cases comprised cell block preparations derived from primary tumor specimens or patient-derived xenografts as part of a pediatric precision oncology trial. Cytopathology cases were compared with the morphology and immunohistochemical staining profile of the original tumor. Cases were reported as tumor cells present, equivocal, or tumor cells absent. The HTS results from cytopathologically validated cultures were incorporated into a multidisciplinary tumor board report issued to the treating clinician to guide clinical decision making.
RESULTS
On cytopathologic examination, tumor cells were present in 77 of 129 cases (60%) and were absent in 38 of 129 cases (29%), whereas 14 of 129 cases (11%) were equivocal. Cultures that contained tumor cells resembled the tumors from which they were derived.
CONCLUSIONS
Cytopathologic examination of tumor cell block preparations is feasible and provides detailed morphologic characterization. Cytopathologic examination is essential for ensuring that samples submitted for HTS contain representative tumor cells and that in vitro drug sensitivity data are clinically translatable.
Topics: Humans; Immunohistochemistry; Medical Oncology; Neoplasms; Pathology; Precision Medicine
PubMed: 34043284
DOI: 10.1002/cncy.22448 -
Archives of Pathology & Laboratory... Oct 2018Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from the American Society of Clinical... (Review)
Review
PURPOSE.—
Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from the American Society of Clinical Oncology and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research.
METHODS.—
An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including preanalytical variables, analytical validity, interpretation and reporting, and clinical validity and utility.
RESULTS.—
The literature search identified 1338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion.
CONCLUSIONS.—
The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens, and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity or clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, reevaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.
Topics: Circulating Tumor DNA; Early Detection of Cancer; Humans; Medical Oncology; Neoplasms; Pathology, Clinical
PubMed: 29504834
DOI: 10.5858/arpa.2018-0901-SA -
Clinics in Laboratory Medicine Mar 2018Like in all areas of science, it is important for funders and investigators of pathology to work together to develop a well-designed, well-executed clinical research... (Review)
Review
Like in all areas of science, it is important for funders and investigators of pathology to work together to develop a well-designed, well-executed clinical research agenda. In the first section of this article, the authors discuss how the National Institutes of Health (NIH) peer-review process applies to global health pathology research projects. Then, the authors present an illustrative sampling of NIH-funded projects with performance sites in low- and middle-income countries with 2 examples focused on cancer and anatomic pathology. Finally, the authors relate the research agenda to overarching strategic recommendations for enhancing global pathology.
Topics: Biomedical Research; Global Health; Humans; National Institutes of Health (U.S.); Neoplasms; Pathologists; Pathology; United States
PubMed: 29412883
DOI: 10.1016/j.cll.2017.10.003 -
Diagnostic Pathology May 2018Telepathology (TP) provides remote pathology services for primary diagnosis practices, including intraoperative consultation of surgical pathology; it has not been...
BACKGROUND
Telepathology (TP) provides remote pathology services for primary diagnosis practices, including intraoperative consultation of surgical pathology; it has not been widely implemented in China. In this study, the results of an implementation were reported, which lasted for two and a half years, and demonstrated the experience of the diagnosis of the intraoperative frozen sections by using TP consultation platform of Southern Medical University and Guangzhou Huayin Medical Laboratory Center (SMU-HUAYIN TP) in China.
METHODS
The SMU-HUAYIN TP consultation platform connects 71 participating basic hospitals and 11 senior pathologists. Nanfang Hospital is a high-level hospital located in a large city in China. This retrospective study summarizes the experience and results of TP for frozen section diagnosis by comparing the data of the platform and Nanfang Hospital over a period of 2.5 years from January 2015 to June 2017.
RESULTS
A total of 5233 cases were submitted to the platform, including 1019 cases in 2015, 2320 cases in 2016, and 1894 cases in 2017. The most common cases were breast (30.42%), followed by thyroid (29.05%) and gynecological (24.86%). Average turn-around time (TAT) of the cases from the platform in 2015 and 2016 was controlled within 30 min. In most TP cases (90.31%) and cases from Nanfang Hospital (86.14%), a definitive diagnosis was provided. The coincidence rate was 99.77% in the TP cases and 99.35% in the cases from Nanfang Hospital. The false positive and false negative rates of TP cases were 0.04 and 0.19%, respectively and no significant difference was found among different senior pathologists (P = 0.974, P = 0.989, P > 0.05). Similarly, there was no significant difference between TP cases and cases from Nanfang Hospital that were diagnosed by the same senior pathologist (P > 0.05).
CONCLUSIONS
Our results indicate that TP in frozen section diagnosis could improve patient care and solve the problem of unevenly distributed pathology resources in China. We believe that in the near future, TP in frozen section diagnosis will become an important component of telemedicine and will play a significant role in health care reform in China.
Topics: China; Frozen Sections; Humans; Intraoperative Period; Neoplasms; Pathology, Surgical; Remote Consultation; Telepathology
PubMed: 29759085
DOI: 10.1186/s13000-018-0705-0 -
BMC Bioinformatics Aug 2014The development of digital imaging technology is creating extraordinary levels of accuracy that provide support for improved reliability in different aspects of the...
BACKGROUND
The development of digital imaging technology is creating extraordinary levels of accuracy that provide support for improved reliability in different aspects of the image analysis, such as content-based image retrieval, image segmentation, and classification. This has dramatically increased the volume and rate at which data are generated. Together these facts make querying and sharing non-trivial and render centralized solutions unfeasible. Moreover, in many cases this data is often distributed and must be shared across multiple institutions requiring decentralized solutions. In this context, a new generation of data/information driven applications must be developed to take advantage of the national advanced cyber-infrastructure (ACI) which enable investigators to seamlessly and securely interact with information/data which is distributed across geographically disparate resources. This paper presents the development and evaluation of a novel content-based image retrieval (CBIR) framework. The methods were tested extensively using both peripheral blood smears and renal glomeruli specimens. The datasets and performance were evaluated by two pathologists to determine the concordance.
RESULTS
The CBIR algorithms that were developed can reliably retrieve the candidate image patches exhibiting intensity and morphological characteristics that are most similar to a given query image. The methods described in this paper are able to reliably discriminate among subtle staining differences and spatial pattern distributions. By integrating a newly developed dual-similarity relevance feedback module into the CBIR framework, the CBIR results were improved substantially. By aggregating the computational power of high performance computing (HPC) and cloud resources, we demonstrated that the method can be successfully executed in minutes on the Cloud compared to weeks using standard computers.
CONCLUSIONS
In this paper, we present a set of newly developed CBIR algorithms and validate them using two different pathology applications, which are regularly evaluated in the practice of pathology. Comparative experimental results demonstrate excellent performance throughout the course of a set of systematic studies. Additionally, we present and evaluate a framework to enable the execution of these algorithms across distributed resources. We show how parallel searching of content-wise similar images in the dataset significantly reduces the overall computational time to ensure the practical utility of the proposed CBIR algorithms.
Topics: Algorithms; Diagnostic Imaging; Feedback; Information Storage and Retrieval; Pathology; Pattern Recognition, Automated; Reproducibility of Results
PubMed: 25155691
DOI: 10.1186/1471-2105-15-287 -
Biochemia Medica Feb 2017There are many activities currently being undertaken in the field of laboratory medicine under the broad heading of "harmonization". These include traceability of... (Review)
Review
There are many activities currently being undertaken in the field of laboratory medicine under the broad heading of "harmonization". These include traceability of results to international reference standards, processes to align results from assays where traceability has not been achieved (analytical harmonization) and international or national clinical guidelines based on studies from many parts of the world. Many of these issues are global in nature, with clinical evidence derived from studies performed in all parts of the world and multinational diagnostic companies providing assays worldwide. As with all aspects of medicine, progress can only be assured where these is evidence of effectiveness of the activities. External Quality Assurance (EQA) programs are designed to meet this need. Currently EQA processes have significant limitations in meeting the global needs of the laboratory medicine community. This paper aims to identify the steps that can be taken to allow current and future EQA programs to provide information on global variation in results. It is only by being aware of result differences that steps can be taken to improve performance.
Topics: Clinical Laboratory Techniques; Humans; Medical Laboratory Science; Pathology, Clinical; Quality Assurance, Health Care; Quality Control
PubMed: 28392723
DOI: 10.11613/BM.2017.004 -
Journal of Global Oncology Nov 2018Fine-needle aspiration biopsy (FNAB) cytology is a simple, inexpensive, and accurate diagnostic test for benign, infectious, and malignant lesions of the breast,...
Task Sharing and Shifting to Provide Pathology Diagnostic Services: The Kenya Fine-Needle Aspiration Biopsy Cytology and Bone Marrow Aspiration and Trephine Biopsy Training Program.
PURPOSE
Fine-needle aspiration biopsy (FNAB) cytology is a simple, inexpensive, and accurate diagnostic test for benign, infectious, and malignant lesions of the breast, thyroid, lymph nodes, and other organs. Similarly, bone marrow aspiration and trephine (BMAT) biopsy procedures are relatively simple and inexpensive techniques that are important for diagnosing and monitoring many hematologic diseases including leukemias and lymphomas. However, the scarcity of pathologists in Kenya limits patient access to these simple diagnostic tests. We describe a task sharing and shifting program that sought to improve the provision of FNABs and BMAT biopsies in tertiary public hospitals in Kenya.
METHODS
Between January 2016 and February 2017, we trained pathologists, pathology residents, and technologists from the University of Nairobi and Aga Khan University Hospital, Nairobi, in FNAB and BMAT biopsies, who in turn trained pathologists, medical officers (MO), clinical officers (CO), and technologists at five tertiary public hospitals. The program involved curriculum development, training workshops, the establishment of new and strengthening existing FNAB and BMAT biopsy clinics, interim site visits, audits, and stakeholder workshops.
RESULTS
Fifty-one medical personnel at the tertiary hospitals were trained. The FNAB numbers increased by 41% to 1,681, with 139 malignant diagnoses (7.1%). BMAT biopsy numbers increased by 268% to 140, with 34 malignant cases. Between 60% and 100% of the FNAB and BMAT biopsy procedures were performed by MO and CO over the project period. One new FNAB and two new BMAT biopsy clinics were established.
CONCLUSION
This project demonstrates a successful model of task sharing and shifting from specialist pathologists to MO and CO that improved access to important FNAB and BMAT biopsy services in a low-resource setting.
Topics: Biopsy, Fine-Needle; Bone Marrow; Cytodiagnosis; Diagnostic Services; Education, Medical, Graduate; Female; Humans; Kenya; Male; Pathology
PubMed: 30398948
DOI: 10.1200/JGO.18.00094 -
Annals of Diagnostic Pathology Feb 2022The COVID-19 pandemic has forced traditional teaching to be re-structured and delivered online.
CONTEXT
The COVID-19 pandemic has forced traditional teaching to be re-structured and delivered online.
OBJECTIVE
To analyse medical students' perceptions about the benefits and difficulties of the remote teaching of Pathology during the COVID-19 pandemic.
DESIGN
A cross-sectional study was performed with an online survey applied to students from the third and fourth year of medical graduation, who attended the remote teaching of Pathology during the COVID-19 pandemic. Online teaching methods consisted of synchronous activities with live interactive lectures, case-based discussions and asynchronous activities with recorded lectures, tutorials and texts available on the online teaching platform. Students' perceptions about the remote teaching of Pathology were assessed through online survey.
RESULTS
Ninety students (47.4%) of 190 participants completed the questionnaire, 45 were male and 52 in the third year of medical graduation. Perceived conditions that facilitated Pathology learning included the use of the online teaching platform and time flexibility for study. Students regarded live interactive lectures as superior to traditional face-to-face lectures. Perceived conditions that hindered the implementation of the online teaching included difficulty separating study from home activities, lack of motivation and worsening of quality of life due to physical distancing from colleagues and the faculty. Overall, the remote teaching of Pathology was positively valued by 80% of the students.
CONCLUSION
Online tools allowed the content of Pathology to be successfully delivered to the students during the COVID-19 pandemic. This experience may be a model for future teaching activities of Pathology in health science education.
Topics: COVID-19; Cross-Sectional Studies; Education, Distance; Female; Humans; Male; Pandemics; Pathology; Students, Medical; Surveys and Questionnaires
PubMed: 34923346
DOI: 10.1016/j.anndiagpath.2021.151875