scholarly journals IFCC interim guidelines on molecular testing of SARS-CoV-2 infection

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Nicasio Mancini ◽  
Tze Ping Loh ◽  
Cheng-Bin Wang ◽  
Matthias Grimmler ◽  
...  
Keyword(s):  
Task Force ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Control Measures ◽  
Contact Tracing ◽  
Molecular Testing ◽  
Case Identification ◽  
Molecular Tests ◽  
Infection Control Measures ◽  
Clinical Laboratories

AbstractThe diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection globally has relied extensively on molecular testing, contributing vitally to case identification, isolation, contact tracing, and rationalization of infection control measures during the coronavirus disease 2019 (COVID-19) pandemic. Clinical laboratories have thus needed to verify newly developed molecular tests and increase testing capacity at an unprecedented rate. As the COVID-19 pandemic continues to pose a global health threat, laboratories continue to encounter challenges in the selection, verification, and interpretation of these tests. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay verification, and (D) test interpretation and limitations for molecular testing of SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories worldwide and highlight the continued importance of laboratory medicine in our collective pandemic response.

scholarly journals COVID-19 outbreak investigation and response in a penitentiary setting: the experience of a prison in Italy, February to April 2020

2021 ◽  
Vol 26 (38) ◽  
Author(s):  
Ruggero Giuliani ◽  
Cristina Cairone ◽  
Lara Tavoschi ◽  
Laura Ciaffi ◽  
Teresa Sebastiani ◽  
...  
Keyword(s):  
Prevention And Control ◽  
Index Case ◽  
Task Force ◽  
Routine Data ◽  
Control Measures ◽  
Contact Tracing ◽  
Case Identification ◽  
Cultural Affinity ◽  
Prevention And Control Measures ◽  
And Control

Prisons are high-risk settings for COVID-19 and present specific challenges for prevention and control. We describe a COVID-19 outbreak in a large prison in Milan between 20 February and 30 April 2020. We performed a retrospective analysis of routine data collected during the COVID-19 emergency in prison. We analysed the spatial distribution of cases and calculated global and specific attack rates (AR). We assessed prevention and control measures. By 30 April 2020, 57 confirmed COVID-19 cases and 66 clinically probable cases were recorded among a population of 1,480. Global AR was 8.3%. The index case was a custodial officer. Two clusters were detected among custodial staff and healthcare workers. On 31 March, a confirmed case was identified among detained individuals. COVID-19 spread by physical proximity or among subgroups with cultural affinity, resulting in a cluster of 22 confirmed cases. Following index case identification, specific measures were taken including creation of a multidisciplinary task-force, increasing diagnostic capacity, contact tracing and dedicated isolation areas. Expanded use of personal protective equipment, environmental disinfection and health promotion activities were also implemented. Outbreaks of COVID-19 in prison require heightened attention and stringent comprehensive measures.

Molecular, serological, and biochemical diagnosis and monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence

2020 ◽  
Vol 58 (7) ◽  
pp. 1037-1052 ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Giuseppe Lippi ◽  
Andrea Horvath ◽  
Sunil Sethi ◽  
David Koch ◽  
...  
Keyword(s):  
Task Force ◽  
Clinical Chemistry ◽  
Critical Role ◽  
Initial Response ◽  
Laboratory Diagnosis ◽  
Disease Diagnosis ◽  
Molecular Testing ◽  
Biochemical Tests ◽  
Regulatory Oversight ◽  
Clinical Laboratories

AbstractThe global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment. Initial response to this pandemic involved the development, production, and distribution of diagnostic molecular assays at an unprecedented rate, leading to minimal validation requirements and concerns regarding their diagnostic accuracy in clinical settings. In addition to molecular testing, serological assays to detect antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now becoming available from numerous diagnostic manufacturers. In both cases, the lack of peer-reviewed data and regulatory oversight, combined with general misconceptions regarding their appropriate use, have highlighted the importance of laboratory professionals in robustly validating and evaluating these assays for appropriate clinical use. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 has been established to synthesize up-to-date information on the epidemiology, pathogenesis, and laboratory diagnosis and monitoring of COVID-19, as well as to develop practical recommendations on the use of molecular, serological, and biochemical tests in disease diagnosis and management. This review summarizes the latest evidence and status of molecular, serological, and biochemical testing in COVID-19 and highlights some key considerations for clinical laboratories operating to support the global fight against this ongoing pandemic. Confidently this consolidated information provides a useful resource to laboratories and a reminder of the laboratory’s critical role as the world battles this unprecedented crisis.

scholarly journals IFCC interim guidelines on biochemical/hematological monitoring of COVID-19 patients

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Simon Thompson ◽  
Mary Kathryn Bohn ◽  
Nicasio Mancini ◽  
Tze Ping Loh ◽  
Cheng-Bin Wang ◽  
...  
Keyword(s):  
Task Force ◽  
Clinical Chemistry ◽  
Risk Scores ◽  
Evidence Based ◽  
Test Interpretation ◽  
Clinical Value ◽  
Clinical Laboratories ◽  
Pandemic Response ◽  
Poor Outcomes ◽  
Hematological Tests

AbstractRoutine biochemical and hematological tests have been reported to be useful in the stratification and prognostication of pediatric and adult patients with diagnosed coronavirus disease (COVID-19), correlating with poor outcomes such as the need for mechanical ventilation or intensive care, progression to multisystem organ failure, and/or death. While these tests are already well established in most clinical laboratories, there is still debate regarding their clinical value in the management of COVID-19, particularly in pediatrics, as well as the value of composite clinical risk scores in COVID-19 prognostication. This document by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 provides interim guidance on: (A) clinical indications for testing, (B) recommendations for test selection and interpretation, (C) considerations in test interpretation, and (D) current limitations of biochemical/hematological monitoring of COVID-19 patients. These evidence-based recommendations will provide practical guidance to clinical laboratories worldwide, underscoring the contribution of biochemical and hematological testing to our collective pandemic response.

scholarly journals High sensitivity, contemporary and point-of-care cardiac troponin assays: educational aids developed by the IFCC Committee on Clinical Application of Cardiac Bio-Markers

2019 ◽  
Vol 57 (5) ◽  
pp. 623-632 ◽  
Author(s):  
Paul O. Collinson ◽  
Amy K. Saenger ◽  
Fred S. Apple ◽  
Keyword(s):  
Cardiac Troponin ◽  
Task Force ◽  
Clinical Chemistry ◽  
Point Of Care ◽  
High Sensitivity ◽  
Laboratory Medicine ◽  
International Federation ◽  
Cardiac Biomarkers ◽  
Educational Materials ◽  
Extensive Information

AbstractThe International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) formed a Task Force on the Application of Cardiac Bio-markers (TF-CB) in 2008, re-designated in 2018 as a committee (C-CB), to produce educational materials on cardiac biomarkers. Established in June 2017, definitive tables covering the majority of high-sensitivity, contemporary and point-of-care (POC) cTn assays have been developed by the C-CB and are available on the IFCC website. These tables provide extensive information about assays’ analytical characteristics and encompass information on diagnostic discriminants, particularly the 99th percentiles, as provided by the manufacturers.

scholarly journals Challenges of Laboratory Medicine: European Answers

2011 ◽  
Vol 30 (4) ◽  
pp. 273-278 ◽  
Author(s):  
Irena Korita ◽  
Victor Blaton
Keyword(s):  
Strategic Alliances ◽  
Business Models ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biomedical Sciences ◽  
Clinical Laboratories ◽  
Laboratory Services ◽  
Enhance Efficiency

Challenges of Laboratory Medicine: European Answers Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistry and Laboratory Medicine are essential for the provision of high-quality preanalytical, analytical and consultative services. Laboratory medicine has undergone major transformations during the last decade. Ongoing technological developments have considerably improved the productivity of clinical laboratories. Information on laboratory services is globally available, and clinical laboratories worldwide face international competition and there is a huge pressure to reduce costs. To be prepared for the future, clinical laboratories should enhance efficiency and reduce the cost increases by forming alliances and networks, consolidating, integrating or outsourcing, and more importantly create additional value by providing knowledge services related to in vitro diagnostics. Therefore, business models that increase efficiency such as horizontal and vertical integration are proposed, based on collaborative networks for the delivery of clinical laboratory services. Laboratories should cooperate, consolidate and form strategic alliances to enhance efficiency and reduce costs. There is a growing conflict between the science and the art of clinical practice and on the role of the biomedical sciences in medical practice. We have a dehumanizing effect on medical care. Disease is defined at the level of sick molecules and cells and curative medicine is being replaced by the preventive care of the disease. Undoubtedly all those questions will raise considerable problems and challenges for the medical educators.

scholarly journals Revised guidelines for Australian laboratories performing mycobacteriology testing

2020 ◽  
Vol 44 ◽  
Author(s):  
Ivan Bastian ◽  
Lisa Shephard ◽  
Richard Lumb ◽  
Keyword(s):  
Peer Review Process ◽  
Contact Tracing ◽  
Molecular Testing ◽  
Reference Laboratory ◽  
Work Practices ◽  
Quality Work ◽  
Molecular Tests ◽  
Assessment Approach ◽  
National Tuberculosis ◽  
Risk Categorisation

Mycobacteriology laboratories play a key role in tuberculosis (TB) control by providing phenotypic and molecular diagnostics, by performing molecular typing to aid contact tracing, and by supporting research and similar laboratories in Australia’s neighbouring countries where TB is prevalent. The National Tuberculosis Advisory Committee (NTAC) published a set of laboratory guidelines in 2006 aiming to document the infrastructure, equipment, staffing and work practices required for safe high-quality work in Australian mycobacteriology laboratories. These revised guidelines have the same aims and have been through a similar extensive consultative peer-review process involving the Mycobacterium Reference Laboratory (MRL) network, the Mycobacterium Special Interest Group (SIG) of the Australian Society for Microbiology (ASM), and other relevant national bodies. This revised document contains several significant changes reflecting the publication of new biosafety guidelines and tuberculosis standards by various national and international organisations, technology developments – such as the MPT64-based immunochromatographic tests (ICTs) and the Xpert MTB/RIF assay, and updated work practices in mycobacteriology laboratories. The biosafety recommendations affirm the latest Australian/New Zealand Standard 2243.3: 2010 and promote a biorisk assessment approach that, in addition to the risk categorisation of the organism, also considers the characteristics of the procedure being performed. Using this biorisk assessment approach, limited manipulations, such as Ziehl-Neelsen (ZN) microscopy, MPT64 ICTs, and culture inactivation/DNA extraction for molecular testing, may be performed on a positive TB culture in a PC2 laboratory with additional features and work practices. Other significant changes include recommendations on the integration of MPT64 ICTs and novel molecular tests into TB laboratory workflows to provide rapid accurate results that improve the care of TB patients. This revised document supersedes the original 2006 publication. NTAC will periodically review these guidelines and provide updates as new laboratory technologies become available.

scholarly journals Antibiotics Used in Covid-19 And Mucormycosis (Black Fungus)

2021 ◽  
Vol 9 (12) ◽  
pp. 1641-1648
Author(s):  
Mr. Chintale Deepak Baliram
Keyword(s):  
Homology Modeling ◽  
Current Knowledge ◽  
Viral Evolution ◽  
Unknown Origin ◽  
International Committee ◽  
Control Measures ◽  
Contact Tracing ◽  
Case Identification ◽  
Health Authorities ◽  
Novel Coronavirus

Abstract: Background: In late December 2019, Chinese health authorities reported an outbreak of pneumonia of unknown origin in Wuhan, Hubei Province. Summary: A few days later, the genome of a novel coronavirus was released. org/t/novel2019-coronavirus-genome/319; Wuhan- Hu-1, GenBank accession No. MN908947) and made publicly available to the scientific community. This novel coronavirus was provisionally named 2019-nCoV, now SARS-CoV-2 according to the Coronavirus Study Group of the International Committee on Taxonomy of Viruses. SARS-CoV-2 belongs to the Coronaviridae family, Betacoronavirus genus, subgenus Sarbecovirus. Since its discovery, the virus has spread globally, causing thousands of deaths and having an enormous impact on our health systems and economies. In this review, we summarize the current knowledge about the epidemiology, phylogenesis, homology modeling, and molecular diagnostics of SARS-CoV-2. Phylogenetic analysis is essential to understand viral evolution, whereas homology modeling is important for vaccine strategies and therapies. Highly sensitive and specific diagnostic assays are key to case identification, contact tracing, identification of the animal source, and implementation of control measures. Keywords: COVID-19 · SARS-CoV-2 · Pandemic · Phylogenesis · Protein modeling · Real-time polymerase chain reaction

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

2018 ◽  
Vol 57 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Min Duan ◽  
Xudong Ma ◽  
Jing Fan ◽  
Yanhong Guo ◽  
Wei Wang ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Turnaround Time ◽  
Laboratory Medicine ◽  
General Information ◽  
Critical Values ◽  
Medical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

A Decisive Review to Understand the Basic Fundamentals of Novel Corona Viruse Disease

2021 ◽  
pp. 118-124
Author(s):  
Sweta Sweta ◽  
Navdeep Singh
Keyword(s):  
Target Selection ◽  
Case Fatality ◽  
The Elderly ◽  
Laboratory Diagnosis ◽  
Control Measures ◽  
Molecular Testing ◽  
Fatality Rate ◽  
Infection Control Measures ◽  
New Public Health ◽  
Novel Coronavirus

With the development and spread of 2019 novel coronavirus (2019-nCoV), also known as the severe acute respiratory syndrome coronavirus 2, a new public health disaster is threatening the world (SARS-CoV-2). In December 2019, the virus was discovered in bats and transmitted to humans via unidentified intermediary species in Wuhan, Hubei Province, China. To date (05/03/2020), there have been roughly 96,000 recorded cases of coronavirus disease 2019 (COVID-2019) and 3300 documented deaths. The disease is spread through inhalation or contact with contaminated droplets, with a 2 to 14-day incubation period. Fever, cough, sore throat, dyspnea, weariness, and malaise are common symptoms. The disease is mild in most people; in some (usually the elderly and those with comorbidities), it can lead to pneumonia, ARDS (acute respiratory distress syndrome), and multi-organ failure. A large number of persons are asymptomatic. The case fatality rate is expected to be between 2 and 3%. Specimen collection, assay collection, serology, nucleic acid testing or molecular testing, and target selection for RT-PCR are all examples of laboratory diagnosis. Home isolation of suspected cases and those with mild illnesses, as well as tight infection control measures in hospitals, including contact and droplet precautions, are all part of the prevention strategy. The virus has a lower fatality rate than its two ancestors, SARS-CoV and Middle East respiratory sickness coronavirus (MERS-CoV). The global consequences of this new epidemic are still unknown.

Teaching Pediatric Laboratory Medicine to Pathology Residents

2006 ◽  
Vol 130 (7) ◽  
pp. 1031-1038
Author(s):  
Theodore J. Pysher ◽  
Philip R. Bach ◽  
Sharon M. Geaghan ◽  
Marilyn S. Hamilton ◽  
Michael Laposata ◽  
...  
Keyword(s):  
Task Force ◽  
Clinical Chemistry ◽  
Point Of Care ◽  
Health Care Systems ◽  
Laboratory Data ◽  
Clinical Pathology ◽  
Laboratory Medicine ◽  
Health Improvement ◽  
Laboratory Diagnostics ◽  
Pediatric Pathology

Abstract Context.—Laboratory data are essential to the medical care of fetuses, infants, children, and adolescents. However, the performance and interpretation of laboratory tests on specimens from these patients, which may constitute a significant component of the workload in general hospitals and integrated health care systems as well as specialized perinatal or pediatric centers, present unique challenges to the clinical pathologist and the laboratory. Therefore, pathology residents should receive training in pediatric laboratory medicine. Objective.—Children's Health Improvement through Laboratory Diagnostics, a group of pathologists and laboratory scientists with interest and expertise in pediatric laboratory medicine, convened a task force to develop a list of curriculum topics, key resources, and training experiences in pediatric laboratory medicine for trainees in anatomic and clinical pathology or straight clinical pathology residency programs and in pediatric pathology fellowship programs. Data Sources.—Based on the experiences of 11 training programs, we have compiled a comprehensive list of pediatric topics in the areas of clinical chemistry, endocrinology, hematology, urinalysis, coagulation medicine, transfusion medicine, immunology, microbiology and virology, biochemical genetics, cytogenetics and molecular diagnostics, point of care testing, and laboratory management. This report also includes recommendations for training experiences and a list of key texts and other resources in pediatric laboratory medicine. Conclusions.—Clinical pathologists should be trained to meet the laboratory medicine needs of pediatric patients and to assist the clinicians caring for these patients with the selection and interpretation of laboratory studies. This review helps program directors tailor their curricula to more effectively provide this training.

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