Implementation Of Diagnostic Tests Research Articles

An Informative Review on screening of COVID-19 (SARS-COVID-II)

Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, named ‘coronavirus disease 2019’ (COVID-19), which threatens human health and public safety. The disease caused by SARS‐CoV‐2, coronavirus disease 2019 (COVID‐19), presents flu‐like symptoms which can become serious in high‐risk individuals. During the early phase of the coronavirus (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively conveyed by a large number of diagnostic test manufacturers. In this Review, we give an outline of the crucial role of diagnostic tests during the first world-wide indication of COVID-19. The severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) and its associated coronavirus (COVID-19) pandemic has demanded rapid up scaling of in-vitro diagnostic assays to enable mass screening and testing of high-risk groups. To encounter the exponential demand in testing, there has been an expedite development of both molecular and serological assays across a superfluity of manifestos. The adjacent review discusses the current information on these modalities, including nucleic acid amplification tests, direct viral antigen tests. In the analytic stage, real-time reverse transcription-PCR (RT-PCR) assays remain the molecular test of choice for the etiologic diagnosis of SARS-CoV-2.

Accuracy of Diagnostic Tests.

Following the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers. This paper deals with the biases and sources of variation which influence the accuracy of diagnostic tests, including calculating and interpreting test characteristics, defining what is meant by test accuracy, understanding the basic study design for evaluating test accuracy, understanding the meaning of Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value, and evaluating them numerically, and the ROC curve (or Receiver Operating Characteristic ) and the Area under the Curve (AUC).

The utilization of rapid serological tests in COVID-19 diagnostics - a high risk of false-negative results in outpatient care, with particular emphasis on dental treatment.

In order to mitigate the spread of COVID-19, in the early stages of the pandemic outbreak, postponing elective procedures was recommended all around the world. Outpatient care and dental care were limited to telephone advice and emergency services. Dental staff is particularly vulnerable to SARS-CoV-2 contraction, because of the inevitable contact with patients' body fluids during aerosol-generating procedures. The implementation of diagnostic tests among ambulatory patients could improve the occupational safety among outpatient care personnel. The aim of this review was to introduce information regarding COVID-19 diagnostics with a particular focus on the methods which can be utilized in an outpatient and dental care setting. An online PubMed database review of articles on COVID-19 diagnostics, published on February 12-May 15, 2020, was conducted. Reverse transcription polymerase chain reaction is the gold standard in COVID-19 diagnostics, which determines if a person has an active infection. Unfortunately, its utilization in outpatient care is limited. Serological enzyme-linked immunosorbent assays identify people who were infected, including those who have had an asymptomatic infection, but they do not give sufficient information about the acute infection. Rapid serological assays developed to facilitate testing outside of laboratories, especially in dental offices, are not recommended by the World Health Organization to be used outside research settings, and they should not constitute the basis for clinical decision-making because of frequent false-negative results which may consequently contribute to personnel infections. Out of all available COVID-19 diagnostic methods, rapid serological assays seemed to be a method of choice in outpatient medical care. Unfortunately, their results turned out to be unreliable. The best methods to ensure the occupational safety of medical staff and to avoid cross-infections in outpatient care facilities include a thorough epidemiological interview, temperature measurement to rule out patients with an active infection, and the implementation of strict infection control procedures. Med Pr. 2021;72(2):155-62.

Considerations for diagnostic COVID-19 tests.

During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers. Hundreds of molecular tests and immunoassays were rapidly developed, albeit many still await clinical validation and formal approval. In this Review, we summarize the crucial role of diagnostic tests during the first global wave of COVID-19. We explore the technical and implementation problems encountered during this early phase in the pandemic, and try to define future directions for the progressive and better use of (syndromic) diagnostics during a possible resurgence of COVID-19 in future global waves or regional outbreaks. Continuous global improvement in diagnostic test preparedness is essential for more rapid detection of patients, possibly at the point of care, and for optimized prevention and treatment, in both industrialized countries and low-resource settings.

Ushering in Diagnostic Stewardship: a Step Towards Antibiotic Stewardship

In recent years, there have been significant developments in rapid diagnostic techniques (RDTs) in microbiology for the diagnosis of infectious diseases. By providing a more rapid diagnosis, RDTs have the potential to affect diagnostic algorithms and therapeutic decisions. In addition to “antibiotic stewardship,” the term “diagnostic stewardship” has recently been coined in clinical practice and denotes the promotion of a rational implementation of diagnostic tests with a view to improving the quality of care and safely reducing cost. This review explores the advancement of diagnostic and antibiotic stewardship in the implementation of RDTs and describes the most relevant related clinical applications in Clostridioides difficile infections (CDIs), bloodstream infections (BSIs), and respiratory infections. An innovative evidence-based RDT diagnostic algorithm that varies according to the presence of pre-agreed institutional criteria significantly increases testing accuracy for differentiating CDIs from carriage status. Evidence on BSIs reveals that pairing RDTs and antibiotic stewardship eases timely and appropriate utilization of RDTs results that may improve the clinical outcomes by optimizing antibiotic use. Data on clinical implications of RDTs targeting antibiotic-resistant Gram-negative and respiratory infections are scarce and inconclusive. Intertwining the role of diagnostic and antibiotic stewardship is crucial to optimizing RDTs utilization, by ensuring that RDTs are rationally selected and implemented, and results correctly interpreted and applied to clinical practice. Further research is needed to explore the clinical implications of RDT implementation.

The Implementation Model of a Diagnostic Test for English Teachers

Professionalism in teaching is one of the key factors in the success of an English education program. To keep the teachers? professionalism, a refresher program is needed to beconducted to improve teachers? competence. To map out the area of teachers? competencewhich should be refreshed, a diagnostic test needs designing. After a diagnostic test has beenmade, the implementation should also be well-conducted to get the representative result.Therefore, this study aims to design an alternative implementation model of a diagnostic testfor English teacher. The questionnaire and focus group discussion results show that theproposed model is an appropriate diagnostic test implementation model for teachers. Keywords: implementation model, diagnostic test, refresher program

FUNCTIONAL BEAM RESEARCH METHODS IN THE DIAGNOSIS OF ABNORMAL MOBILITY OF KIDNEY

Abstract: Introduction. Abnormal mobility of kidney - a combination nephroptosis with abnormal rotation in one or more static state. The main beam is at present diagnostic methods. Only ultrasound has the functionality, the ability to use polypositional. The purpose of the study. Development of functional radiological methods of diagnosis of pathological mobility of the kidney and its complications. Research methods. The methods of determining the angle of rotation according to the kidney excretory urography performed in wedge and orthostasis, ultrasound sonography, Doppler, dynamic indirect kidney scan and computed tomography. Statistical processing of the data using the package STATISTICA 6.0 software licensing and computer programs, correlation analysis, frequency and multiple correspondence analysis. The main results. To determine the location of each case properly distributed in accordance with the classification matrices further method was used polypositional ultrasound, which allowed to determine the position of the patient, which revealed significant correlated with the RMS, hemoand urodynamic changes. Application rentgenradiological diagnostic methods in the corresponding position of the fixed kidney complications pathological mobility. The main conclusions. The combination of ultrasonic, radiographic, radioisotope diagnostic PMK and its complications allows us to supplement the information content of these studies and to expand the diagnostic value of each of them. An integrated approach to the implementation of diagnostic tests will improve the efficiency of the treatment of complications PMK, reduce material costs, which in turn will improve the quality of treatment of patients with this pathology.

Regulation in Hemostasis and Thrombosis: Part I—In Vitro Diagnostics

The diagnostic or test-performance process, as associated to the evaluation or diagnosis of hemostasis and thrombosis and related disorders, is influenced or controlled by the activity of a large number of professional, expert, and government organizations. These may be involved in driving standardization or harmonization, providing professional or expert guidelines, or in regulation of therapeutic products and diagnostic products such as in vitro diagnostic devices or reagents (IVDs). Although all organizations involved in this activity would propose an intention to drive improvements in diagnostics and human health and although there are benefits to the overall process of standardization and regulation for tests of hemostasis and thrombosis, it should also be recognized there are several specific problems and limitations to this process. As highlighted in this report, which specifically relates to the regulation of IVDs, several case studies are used as examples to show that regulation, aimed to reduce risks associated with the implementation of diagnostic testing, may instead encourage the adverse outcome of locking out clinically useful, new, and improved technologies and locking in old and outdated technologies. This has a potential for significant adverse outcomes related to the clinical diagnosis and management of hemostasis and thrombosis-related disorders.

Interrelationships among enrichment with diagnostics, probability of success and demonstration of effectiveness in clinical trials

Background: Prevalence of disease phenotype in clinical practice is often not given adequate importance during formulation, validation, and implementation of diagnostic tests in clinical research and development. After promising biomarkers have been identified as potential screening diagnostics, an important strategic question for optimal decision-making in clinical development of a therapeutic is when to choose an enrichment study design over the traditional all-comer randomized control trial design. Methods: A hypothetical example of a cholesterol lowering treatment is used to illustrate influences of key statistical criteria and clinical considerations for choosing study designs. Computer simulations demonstrate how results of such analyses can aid in deciding whether or not to choose enrichment study designs. Results: This study shows how understanding of disease prevalence in practice, predictive values of diagnostic test, and prespecified establishment of a clinically meaningful minimum effectiveness all need to be integrated to insure clinical trial success and appropriate benefit to targeted patient subgroups. The most important statistical and clinical considerations were the anticipated effect size, phenotype prevalence, predictive values of diagnostics test, study power, and desired clinically meaningful difference. Conclusions: This study illustrates how successful clinical studies can be designed with careful planning and utilization of computer simulations to increase not only the probability of trial success but also to demonstrate to payers convincing evidence of clinical effectiveness. A six-step checklist is recommended as an evidence-based guideline to assist in decision-making on whether or not to adopt a diagnostics enriched clinical study design.

Perspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests

In recent years, there has been significant investment from both the private and public sectors in the development of diagnostic technologies to meet the need for human immunodeficiency virus (HIV) and tuberculosis testing in low-resource settings. Future investments should ensure that the most appropriate technologies are adopted in settings where they will have a sustainable impact. Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct. Here, we discuss these considerations from different perspectives representing those of various stakeholders involved in the development, introduction, and implementation of diagnostic tests. We also discuss some opportunities to address these considerations.

Syncope: many studies and few diagnoses?

Syncope is a frequent disorder shows diagnostic difficulties, so that an important percentage of patients remain without diagnosis after the implementation of diagnostic tests that sometimes are unnecessary. A retrospective analysis of the patients admitted during a period of two years because of syncope in an Internal Medicine Service was carried out. Of a total of 2,878 patients hospitalized during the years 1999 and 2000, 79 were admitted because of syncope (2.74%). Forty-five (57%) were men and 34 (43%) were women, with a median age of 68.8 years. Twenty-seven patients (34%) had history of syncope. After a median hospitalization of 9.5 days, the etiological diagnosis was established in 53 (67%) patients: in 25 patients (31.6%) the syncope was mediated by neurological mechanisms, in 16 (20.25%) it was of cardiology origin, in 4 (5.06%) it was of neurological origin and in 8 (10.1%) the syncope was secondary to other causes. In 54 patient (68.8%) at least one cardiology test was carried out (41 Holter, 32 echocardiograms, 6 tilt board tests, 3 maneuvers of massage of the carotid sinus, 3 ergometry studies, 3 electrophysiological studies, 2 coronary angiographies and 3 ventilation perfusion lung gammagraphies). In 51 patient (64%) at least one neurological test was carried out (31 EEG, 42 CT, 2 MNR, 1 Doppler cranial ultrasound and 3 electroneuromyogram). Only 4 of the Holter carried out were diagnostic, as well as 3 of the echocardiograms and only 2 of the CT carried out. No EEG was useful for the etiological diagnosis of the syncope. There is an excessive utilization of some diagnostic tests (EEG, Holter, cerebral CT), in spite of which in an important percentage of patients with syncope the etiological diagnosis is no done (33%). The use of diagnostic algorithms based on detailed clinical history, physical exploration and assessment of the ECG is proposed, that they would make it possible to issue a diagnostic hypothesis from which there could be begun the diagnostic study with a use as rational as possible of the complementary examinations.

The Role of the Clinical Laboratory in Managing Chemical or Biological Terrorism

Domestic and international acts of terrorism using chemicals and pathogens as weapons have recently attracted much attention because of several hoaxes and real incidents. Clinical laboratories, especially those affiliated with major trauma centers, should be prepared to respond rapidly by providing diagnostic tests for the detection and identification of specific agents, so that specific therapy and victim management can be initiated in a timely manner. As first-line responders, clinical laboratory personnel should become familiar with the various chemical or biological agents and be active participants in their local defense programs. We review the selected agents previously considered or used in chemical and biological warfare, outline their poisonous and pathogenic effects, describe techniques used in their identification, address some of the logistical and technical difficulties in maintaining such tests in clinical laboratories, and comment on some of the analytical issues, such as specimen handling and personal protective equipment. The chemical agents discussed include nerve, blistering, and pulmonary agents and cyanides. Biological agents, including anthrax and smallpox, are also discussed as examples for organisms with potential use in bioterrorism. Available therapies for each agent are outlined to assist clinical laboratory personnel in making intelligent decisions regarding implementation of diagnostic tests as a part of a comprehensive defense program. As the civilian medical community prepares for biological and chemical terrorist attacks, improvement in the capabilities of clinical laboratories is essential in supporting counterterrorism programs designed to respond to such attacks. Accurate assessment of resources in clinical laboratories is important because it will provide local authorities with an alternative resource for immediate diagnostic analysis. It is, therefore, recommended that clinical laboratories identify their current resources and the extent of support they can provide, and inform the authorities of their state of readiness.