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ReviewPublication 2022Diagnostics for COVID-19: Moving from Pandemic Response to Control
Diagnostics are essential in managing the COVID-19 pandemic, with three primary methods for detecting SARS-CoV-2 …
Diagnostics are essential in managing the COVID-19 pandemic, with three primary methods for detecting SARS-CoV-2 infections. Each test type remains vital as we shift from responding to controlling the pandemic. Molecular tests, like PCR, are highly precise in identifying viral RNA and are endorsed by the WHO for confirming cases and guiding public health actions. Antigen rapid tests spot viral proteins and, while less accurate than molecular tests, are quicker, more affordable, simpler, and can…
Clinical Care | Test Performance | Infectious Diseases | Health Systems | Health/Medicine | Science/Technology -
ReviewPublication 2022Rapid, Point-of-Care Antigen Tests for Diagnosis of SARS-CoV-2 Infection
This study reviewed the diagnostic accuracy of rapid, point-of-care antigen tests for detecting SARS-CoV-2 infection, …
This study reviewed the diagnostic accuracy of rapid, point-of-care antigen tests for detecting SARS-CoV-2 infection, differentiating results between symptomatic and asymptomatic individuals. Using data from 155 study cohorts, the study found that the sensitivity of antigen tests was generally higher for symptomatic individuals, especially during the first week after symptom onset, due to higher viral loads. For example, average sensitivity was higher in symptomatic (73.0%) compared to asymptomatic participants (54.7). Average sensitivity was higher in…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ToolWeb Portal 2023CDC Resource Portal: Diagnostic Tests for SARS-CoV-2
The Centers for Disease Control and Prevention (CDC) provides a broad range of resources about …
The Centers for Disease Control and Prevention (CDC) provides a broad range of resources about diagnostic tests for SARS-CoV-2 aimed at the general public, health professionals and laboratory personnel. The overviews and guidelines for health professionals provide comprehensive information about the current available diagnostics, their strengths and limitations, their performance characteristics and guidelines for their use and interpretation. Selected topics included are provided below. Overview of Testing for SARS-CoV-2, the Virus That Causes COVID-19. Interim…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ArticlePublication 2016Spectrum Effect in Tests for Risk Prediction, Screening, and Diagnosis
This article discusses the impact of the spectrum effect on measures of test performance, and …
This article discusses the impact of the spectrum effect on measures of test performance, and its implications for the development, evaluation, application, and implementation of such tests. The authors describe this effect as the variation between settings in performance of tests used to predict, screen for, and diagnose disease among different population subgroups. They emphasize that a test developed in a population with a higher prevalence of disease (or at higher risk) will typically have…
Clinical Care | Evidence Synthesis | Test Performance | Health/Medicine | Science/Technology -
ArticlePublication 2020Clinical Decision Making: Using a Diagnostic Test
This article is part of a 6-part series on clinical decision making. The authors use …
This article is part of a 6-part series on clinical decision making. The authors use two clinical examples to review the principles of interpreting diagnostic test results. They outline an approach that can be used to determine how to select and apply tests and their results to the practice of internal medicine. Topics covered in the two case studies include sensitivity and specificity, positive predictive and negative predictive value of tests, and how to estimate…
Clinical Care | Probability/Bayes | Test Performance | Health/Medicine -
EditorialPublication 2020Diagnostic Testing for the Novel Coronavirus
This perspective provides insights about the controversies over diagnostic testing that have dominated U.S. headlines …
This perspective provides insights about the controversies over diagnostic testing that have dominated U.S. headlines regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease-2019 (COVID-19). The authors review early testing challenges, beginning with the initial technical problems with the first test developed by the Centers for Disease Control and Prevention (CDC), which left the U.S. with inadequate diagnostic capacity early in the epidemic. They discuss the "diagnostic testing gap"…
Clinical Care | Test Performance | Infectious Diseases | Policy/Regulation | Government/Law | Health/Medicine | Science/Technology | North America -
Tools/ModelsInteractive, Teaching Resource 2020Interactive Graphic: Interpreting a COVID-19 Test Result
Currently, the most common diagnostic test for COVID-19 relies on reverse transcriptase polymerase chain reaction …
Currently, the most common diagnostic test for COVID-19 relies on reverse transcriptase polymerase chain reaction (RT-PCR), and most often uses samples obtained from the respiratory tract by nasopharyngeal swab. This interactive graphic demonstrates the influence of the prior probability of COVID-19, the test sensitivity (i.e., the probability of a positive test conditional on disease presence), and the test specificity (i.e., the probability of a negative test conditional on disease absence) on the post-test probability of…
Clinical Care | Probability/Bayes | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | High School | College | Graduate | Doctoral | Professional | Graphics/Visualization | Quantitative Literacy -
ArticlePublication 2020Bayes' Theorem, COVID-19, and Screening Tests
This article reviews the implications of increased testing for COVID-19 using reverse transcriptase polymerase chain …
This article reviews the implications of increased testing for COVID-19 using reverse transcriptase polymerase chain reaction (rRT-PCR) through the application of Bayes’ Theorem for three hypothetical, stylized case scenarios. The scenarios involve three patients with a low, moderate, and high pre-test probability of COVID-19 infection. The category of low probability would include "asymptomatic individuals in a presumed low prevalence environment" and might vary from 10 to 20%. The category of moderate probability would include "individuals…
Clinical Care | Probability/Bayes | Test Performance | Infectious Diseases | Health/Medicine -
EditorialPublication 2020False Negative Tests for SARS-CoV-2 Infection – Challenges and Implications
This article discusses the implications of uncertain test performance within the contextualized rationale for widespread …
This article discusses the implications of uncertain test performance within the contextualized rationale for widespread SARS-CoV-2 testing as essential to safely reopen the U.S. They argue that while much attention has been given to test availability, test accuracy may be the larger long-term problem. Authors provide a solid review of the relationship and influence of the prior probability, test sensitivity, and test specificity on the post-test probability of disease. They connect the quantitative information with…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine -
ToolInteractive 2020COVID-19 Antibody Tests: Calculator for Interpreting Test Results
Antibody testing can determine previous exposure to SARS-CoV-2 virus. This interactive calculator, linked to the article …
Antibody testing can determine previous exposure to SARS-CoV-2 virus. This interactive calculator, linked to the article below* on antibody testing for SARS-CoV-2 virus, allows users to vary the prior probability of infection, the sensitivity of SARS-CoV-2 antibody testing, and the specificity of SARS-CoV-2 antibody testing. Key points made in the article accompanying the interactive include: (1) antibody testing is likely to be most useful 2 weeks after infection, (2) sensitivity and specificity will vary over time and…
Clinical Care | Probability/Bayes | Test Performance | Technology Assessment | Infectious Diseases | Health/Medicine | Science/Technology -
ArticlePublication 2020Testing for SARS-CoV-2 Antibodies
Antibody testing can determine previous exposure to SARS-CoV-2 virus. Recently, the UK government has made …
Antibody testing can determine previous exposure to SARS-CoV-2 virus. Recently, the UK government has made antibody testing available to anyone wanting it, even if there is no clinical indication. The purpose of this article is to provide guidance for when to consider antibody testing in individuals with and without symptoms suggestive of current or past SARS-CoV-2 infection. Key points made by the authors include: (1) antibody testing is likely to be most useful 2 weeks…
Clinical Care | Probability/Bayes | Test Performance | Technology Assessment | Infectious Diseases | Health/Medicine -
ArticlePublication 2020Explosion of New Coronavirus Tests That Could Help to End the Pandemic
The standard test to detect SARS-CoV-2, the reverse-transcription polymerase chain reaction, or RT-PCR, requires trained …
The standard test to detect SARS-CoV-2, the reverse-transcription polymerase chain reaction, or RT-PCR, requires trained personnel, specific chemical supplies and expensive instruments that take hours to provide results and are often available only in labs that provide routine, centralized services. This limits the number of tests that can be done, especially in developing countries. Research groups around the world are now devising tests that go beyond PCR. Dozens of diagnostic methods are in development, all of…
Clinical Care | Test Performance | Infectious Diseases | Business/Industry | Health/Medicine -
ReviewPublication 2020Antibody Tests for Identification of Current and Past Infection with SARS-CoV-2
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and resulting COVID-19 pandemic present important …
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic strategies are available to identify current infection, rule out infection, identify people in need of care escalation, or to test for past infection and immune response. Serology tests to detect the presence of antibodies to SARS-CoV-2 aim to identify previous SARS-CoV-2 infection and may help to confirm the presence of current infection. The objective of this…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology -
ReviewPublication 2020Performance Characteristics of 5 Immunoassays for SARS-CoV-2
SARS-CoV-2 antibodies typically start to appear at least 5–7 days post infection and are therefore …
SARS-CoV-2 antibodies typically start to appear at least 5–7 days post infection and are therefore an unreliable marker for early acute infection. The degree and duration of immunity that antibodies confer are unclear. A prominent use for serological testing has therefore been at a population level, for informing the extent of population exposure. Immunoassays used for SARS-CoV-2 testing detect either specific types of antibody (e.g., IgM or IgG) or total antibody. To date, few thorough, direct…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology -
ReviewPublication 2020Rapid, Point-of-Care Tests for Diagnosis of SARS-CoV-2 Infection
Several diagnostic strategies are available to identify or rule out current infection with SARS-CoV-2, identify …
Several diagnostic strategies are available to identify or rule out current infection with SARS-CoV-2, identify people in need of care escalation, or to test for past infection and immune response. Point-of-care antigen and molecular tests to detect current SARS-CoV-2 infection have the potential to allow earlier detection and isolation of confirmed cases compared to laboratory-based diagnostic methods, with the aim of reducing household and community transmission. This study sought to assess the diagnostic accuracy of point-of-care antigen and…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology -
ArticlePublication 2023Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection
The objective of this study was to evaluate the performance of rapid antigen tests (Ag-RDTs) …
The objective of this study was to evaluate the performance of rapid antigen tests (Ag-RDTs) for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. The general findings were that the performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days. They…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ArticlePublication 2020Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure
This study aimed to determine the false-negative rate of RT-PCR tests for SARS-CoV-2 infection based …
This study aimed to determine the false-negative rate of RT-PCR tests for SARS-CoV-2 infection based on the timeline of exposure and symptom onset. Drawing from data in seven studies involving 1,330 upper respiratory tract samples, a Bayesian model was used to estimate these rates. Findings showed that in the initial four days prior to typical symptom onset, the false-negative rate decreased from 100% on day 1 to 67% on day 4. By the day of…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ReviewPublication 2021Considerations for Diagnostic COVID-19 Tests
During the initial stages of the COVID-19 pandemic, there was a rush by numerous diagnostic …
During the initial stages of the COVID-19 pandemic, there was a rush by numerous diagnostic test manufacturers to create, validate, and implement testing methods. This review discusses the pivotal role of diagnostic tests during the pandemic's first global wave, highlighting the challenges in technology and implementation experienced early on. The study also offers insights for enhancing the use of diagnostics, especially syndromic ones, should there be future spikes or regional outbreaks of COVID-19. The overarching…
Clinical Care | Test Performance | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ArticlePublication 2022Estimated Transmission Outcomes and Costs of SARS-CoV-2 Diagnostic Testing, Screening, and Surveillance Strategies Among a Simulated Population of Primary School Students
In the wake of the COVID-19 pandemic's significant educational disruptions, the U.S. government allocated $10 …
In the wake of the COVID-19 pandemic's significant educational disruptions, the U.S. government allocated $10 billion in March 2021 for testing in schools. The study aimed to analyze the costs and benefits of different COVID-19 testing strategies, particularly focusing on full-time, in-person elementary and middle school education. Utilizing an updated agent-based network model, the study simulated transmission scenarios in schools, considering various testing strategies ranging from diagnostic testing (test-to-stay) to reduce symptom-based isolations, routine screening…
Clinical Care | Test Performance | Mathematical Models | Cost-Effectiveness Analysis | Infectious Diseases | Health/Medicine | Science/Technology | North America -
ReviewPublication 2022Significance of Advanced COVID-19 Diagnostic Testing in Pandemic Control Measures
Over the past two years of the COVID-19 pandemic, the scientific community has mounted significant …
Over the past two years of the COVID-19 pandemic, the scientific community has mounted significant efforts to combat the highly transmissible SARS-CoV-2 virus. Despite substantial progress in vaccines and treatments, leading to lower hospitalization and death rates, the virus has continued to evolve, primarily through mutations. From the onset, diagnostic tests have been crucial in identifying and controlling the virus spread. The scientific world has pioneered various diagnostic techniques, including nucleic acid, antigen, and antibody-based…
Clinical Care | Test Performance | Infectious Diseases | Health Systems | Health/Medicine | Science/Technology | North America -
ArticlePublication 2022Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection
As the availability of at-home self-collected antigen tests for SARS-CoV-2 increases, understanding their efficacy is …
As the availability of at-home self-collected antigen tests for SARS-CoV-2 increases, understanding their efficacy is crucial. A study in San Diego and Denver between January and May 2021 assessed the reliability of these tests against standard RT-PCR tests and viral cultures. Of the 225 participants with confirmed infections, the antigen test sensitivity was found to be 50% during the infectious period, 64% against the same-day RT-PCR, and 84% against the same-day cultures. Sensitivity was highest…
Clinical Care | Test Performance | Infectious Diseases | Culture/Society | Health/Medicine | Science/Technology
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