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The Journal of Urology Aug 2021
Topics: Diagnostic Tests, Routine; Humans; Magnetic Resonance Imaging
PubMed: 33993708
DOI: 10.1097/JU.0000000000001864 -
The Journal of Urology May 2021
Topics: Diagnostic Tests, Routine; Humans; Magnetic Resonance Imaging
PubMed: 33625904
DOI: 10.1097/JU.0000000000001672 -
The Journal of Urology Jan 2020
Topics: Diagnostic Tests, Routine; Humans; Prospective Studies; Watchful Waiting
PubMed: 31479394
DOI: 10.1097/JU.0000000000000520 -
Clinical Microbiology and Infection :... Jun 2020Cerebrospinal fluid (CSF) testing is a key component for the diagnosis of central nervous system (CNS) infections. Current meningitis and encephalitis management... (Review)
Review
BACKGROUND
Cerebrospinal fluid (CSF) testing is a key component for the diagnosis of central nervous system (CNS) infections. Current meningitis and encephalitis management guidelines agree on the need for CSF molecular testing in combination with other direct and indirect biological testing, both in CSF and blood. Multiplex molecular tests have been developed to reduce turnaround times and facilitate the diagnostic approach.
OBJECTIVES
We aim to discuss the role of multiplex molecular panels in the management of CNS infections.
SOURCES
The MEDLINE database and the grey literature have been searched for relevant articles.
CONTENT
New molecular multiplex panels are being developed to simultaneously detect a large array of neuropathogens in CSF. Although one of these assays has been US Food and Drug Administration-approved, extensive analytical and clinical validation is still missing, and suboptimal performance related issues have been raised. Its use has been associated with decreased costs, reduced length of hospital stay and reduced antiviral therapy administration in retrospective, industry-sponsored studies. The pros and cons of this multiplex syndromic approach are discussed in this narrative review.
IMPLICATIONS
Molecular multiplex CNS infection diagnosis panels have been developed and present several attractive features, including ease of use and low turnaround time. However, suboptimal analytical performances render these tests difficult to use without additional confirmatory tests. Such panels are not comprehensive nor adapted to all situations, depending on the epidemiological or clinical context. Overall, available data in the literature currently do not support the use of a multiplex PCR panel in clinical routine as a 'stand-alone' molecular assay. Except in restricted laboratory capacity settings where such easy-to-use multiplex panels offer the diagnostic means that would otherwise not be available, the stepwise testing approach remains a more rational option. Serological testing both in blood and CSF should not be neglected, but it represents essential complementary tools regarding some neuropathogens.
Topics: Central Nervous System Infections; Diagnostic Tests, Routine; Encephalitis; Humans; Meningitis; Molecular Diagnostic Techniques; Retrospective Studies
PubMed: 31899336
DOI: 10.1016/j.cmi.2019.12.013 -
Statistics in Medicine Jul 2022The development of a new diagnostic test ideally follows a sequence of stages which, among other aims, evaluate technical performance. This includes an analytical...
The development of a new diagnostic test ideally follows a sequence of stages which, among other aims, evaluate technical performance. This includes an analytical validity study, a diagnostic accuracy study, and an interventional clinical utility study. In this article, we propose a novel Bayesian approach to sample size determination for the diagnostic accuracy study, which takes advantage of information available from the analytical validity stage. We utilize assurance to calculate the required sample size based on the target width of a posterior probability interval and can choose to use or disregard the data from the analytical validity study when subsequently inferring measures of test accuracy. Sensitivity analyses are performed to assess the robustness of the proposed sample size to the choice of prior, and prior-data conflict is evaluated by comparing the data to the prior predictive distributions. We illustrate the proposed approach using a motivating real-life application involving a diagnostic test for ventilator associated pneumonia. Finally, we compare the properties of the approach against commonly used alternatives. The results show that, when suitable prior information is available, the assurance-based approach can reduce the required sample size when compared to alternative approaches.
Topics: Bayes Theorem; Diagnostic Tests, Routine; Humans; Reproducibility of Results; Sample Size
PubMed: 35403239
DOI: 10.1002/sim.9393 -
Trends in Molecular Medicine Dec 2020Children suffering from infectious diseases, both bacterial and viral, are often treated with empirical antibiotics. Keeping in mind both the menace of microorganisms... (Review)
Review
Children suffering from infectious diseases, both bacterial and viral, are often treated with empirical antibiotics. Keeping in mind both the menace of microorganisms and antibiotic toxicity, it is imperative to develop point-of-care testing (POCT) to discriminate bacterial from viral infections, and to define indications for antibiotic treatment. This article reviews potential protein biomarkers and host-derived gene expression signatures for differentiating between bacterial and viral infections in children, and focuses on emerging multiplex POCT devices for the simultaneous detection of sets of protein biomarkers or streamlined gene expression signatures that may provide rapid and cost-effective pathogen-discriminating tools.
Topics: Age Factors; Bacterial Infections; Biomarkers; Child; Diagnosis, Differential; Diagnostic Tests, Routine; Host-Pathogen Interactions; Humans; Point-of-Care Testing; Virus Diseases
PubMed: 33008730
DOI: 10.1016/j.molmed.2020.09.004 -
Journal of Clinical Virology : the... Aug 2021In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon... (Review)
Review
In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.
Topics: Clinical Laboratory Services; Colorado; Diagnostic Tests, Routine; Humans; Laboratories; United States; United States Food and Drug Administration
PubMed: 34243115
DOI: 10.1016/j.jcv.2021.104875 -
The Journal of Thoracic and... Jun 2020
Topics: Diagnostic Tests, Routine; Humans; Induced Pluripotent Stem Cells; Myocytes, Cardiac
PubMed: 31471083
DOI: 10.1016/j.jtcvs.2019.07.041 -
Clinical Microbiology and Infection :... Feb 2021Rapid diagnostic tests (RDTs) for infectious diseases, with a turnaround time of less than 2 hours, are promising tools that could improve patient care, antimicrobial... (Review)
Review
BACKGROUND
Rapid diagnostic tests (RDTs) for infectious diseases, with a turnaround time of less than 2 hours, are promising tools that could improve patient care, antimicrobial stewardship and infection prevention in the emergency department (ED) setting. Numerous RDTs have been developed, although not necessarily for the ED environment. Their successful implementation in the ED relies on their performance and impact on patient management.
OBJECTIVES
The aim of this narrative review was to provide an overview of currently available RDTs for infectious diseases in the ED.
SOURCES
PubMed was searched through August 2019 for available studies on RDTs for infectious diseases. Inclusion criteria included: commercial tests approved by the US Food and Drug Administration (FDA) or Conformité Européenne (CE) in vitro diagnostic devices with data on clinical samples, ability to run on fully automated systems and result delivery within 2 hours.
CONTENT
A nonexhaustive list of representative commercially available FDA- or CE-approved assays was categorized by clinical syndrome: pharyngitis and upper respiratory tract infection, lower respiratory tract infection, gastrointestinal infection, meningitis and encephalitis, fever in returning travellers and sexually transmitted infection, including HIV. The performance of tests was described on the basis of clinical validation studies. Further, their impact on clinical outcomes and anti-infective use was discussed with a focus on ED-based studies.
IMPLICATIONS
Clinicians should be familiar with the distinctive features of each RDT and individual performance characteristics for each target. Their integration into ED work flow should be preplanned considering local constraints of given settings. Additional clinical studies are needed to further evaluate their clinical effectiveness and cost-effectiveness.
Topics: Automation, Laboratory; Communicable Diseases; Diagnostic Test Approval; Diagnostic Tests, Routine; Emergency Service, Hospital; Europe; Humans; Reagent Kits, Diagnostic; United States; United States Food and Drug Administration
PubMed: 32120036
DOI: 10.1016/j.cmi.2020.02.024 -
Eye (London, England) Oct 2019
Topics: Cataract Extraction; Diagnostic Tests, Routine; Humans; Patient Safety
PubMed: 31289354
DOI: 10.1038/s41433-019-0526-8