scholarly journals Quantitative Comparison of SARS-CoV-2 Nucleic Acid Amplification Test and Antigen Testing Algorithms: A Decision Analysis Simulation Model

2021 ◽  
Author(s):  
Phillip P. Salvatore ◽  
Melisa M. Shah ◽  
Laura Ford ◽  
Augustina Delaney ◽  
Christopher H. Hsu ◽  
...  
Keyword(s):  
Public Health ◽  
Nucleic Acid ◽  
Decision Analysis ◽  
Quantitative Comparison ◽  
Nucleic Acid Amplification ◽  
Infection Prevalence ◽  
Health Organizations ◽  
Public Health Organizations ◽  
Antigen Tests ◽  
Antigen Testing

AbstractBackgroundAntigen tests for SARS-CoV-2 offer advantages over nucleic acid amplification tests (NAATs, such as RT-PCR), including lower cost and rapid return of results, but show reduced sensitivity. Public health organizations continue to recommend different strategies for utilizing NAATs and antigen tests in various settings. There has not yet been a quantitative comparison of the expected performance of these strategies.MethodsWe utilized a decision analysis approach to simulate the expected outcomes of six algorithms for implementing NAAT and antigen testing, analogous to testing strategies recommended by public health organizations. Each algorithm was simulated 50,000 times for four SARS-CoV-2 infection prevalence levels ranging from 5% to 20% in a population of 100000 persons seeking testing. Primary outcomes were number of missed cases, number of false-positive diagnoses, and total test volumes. Outcome medians and 95% uncertainty ranges (URs) were reported.ResultsAlgorithms that use NAATs to confirm all negative antigen results minimized missed cases but required high NAAT capacity: 92,200 (95% UR: 91,200-93,200) tests (in addition to 100,000 antigen tests) at 10% prevalence. Substituting repeat antigen testing in lieu of NAAT confirmation of all initial negative antigen tests resulted in 2,280 missed cases (95% UR: 1,507-3,067) at 10% prevalence. Selective use of NAATs to confirm antigen results when discordant with symptom status (e.g., symptomatic persons with negative antigen results) resulted in the most efficient use of NAATs, with 25 NAATs (95% UR: 13-57) needed to detect one additional case at 10% prevalence compared to exclusive use of antigen tests.ConclusionsNo single SARS-CoV-2 testing algorithm is likely to be optimal across settings with different levels of prevalence and for all programmatic priorities; each presents a trade-off between prioritized outcomes and resource constraints. This analysis provides a framework for selecting setting-specific strategies to achieve acceptable balances and trade-offs between programmatic priorities and constraints.DisclaimerThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.

scholarly journals Quantitative comparison of SARS-CoV-2 nucleic acid amplification test and antigen testing algorithms: a decision analysis simulation model

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Phillip P. Salvatore ◽  
Melisa M. Shah ◽  
Laura Ford ◽  
Augustina Delaney ◽  
Christopher H. Hsu ◽  
...  
Keyword(s):  
Public Health ◽  
Nucleic Acid ◽  
Decision Analysis ◽  
Quantitative Comparison ◽  
Nucleic Acid Amplification ◽  
Health Organizations ◽  
Trade Offs ◽  
Public Health Organizations ◽  
Testing Algorithms ◽  
Antigen Tests

Abstract Background Antigen tests for SARS-CoV-2 offer advantages over nucleic acid amplification tests (NAATs, such as RT-PCR), including lower cost and rapid return of results, but show reduced sensitivity. Public health organizations recommend different strategies for utilizing NAATs and antigen tests. We sought to create a framework for the quantitative comparison of these recommended strategies based on their expected performance. Methods We utilized a decision analysis approach to simulate the expected outcomes of six testing algorithms analogous to strategies recommended by public health organizations. Each algorithm was simulated 50,000 times in a population of 100,000 persons seeking testing. Primary outcomes were number of missed cases, number of false-positive diagnoses, and total test volumes. Outcome medians and 95% uncertainty ranges (URs) were reported. Results Algorithms that use NAATs to confirm all negative antigen results minimized missed cases but required high NAAT capacity: 92,200 (95% UR: 91,200-93,200) tests (in addition to 100,000 antigen tests) at 10% prevalence. Selective use of NAATs to confirm antigen results when discordant with symptom status (e.g., symptomatic persons with negative antigen results) resulted in the most efficient use of NAATs, with 25 NAATs (95% UR: 13-57) needed to detect one additional case compared to exclusive use of antigen tests. Conclusions No single SARS-CoV-2 testing algorithm is likely to be optimal across settings with different levels of prevalence and for all programmatic priorities. This analysis provides a framework for selecting setting-specific strategies to achieve acceptable balances and trade-offs between programmatic priorities and resource constraints.

scholarly journals Performance of antigen testing for diagnosis of COVID-19: a direct comparison of a lateral flow device to nucleic acid amplification based tests

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maria Kahn ◽  
Lukas Schuierer ◽  
Christina Bartenschlager ◽  
Stephan Zellmer ◽  
Ramona Frey ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Real Life ◽  
Lateral Flow ◽  
Nucleic Acid Amplification ◽  
University Hospital ◽  
Nasopharyngeal Swab ◽  
Screening Programs ◽  
Asymptomatic Patients ◽  
Antigen Tests ◽  
Antigen Testing

Abstract Objectives The gold standard for diagnosing an infection with SARS-CoV-2 is detection of viral RNA by nucleic acid amplification techniques. Test capacities, however, are limited. Therefore, numerous easy-to-use rapid antigen tests based on lateral flow technology have been developed. Manufacturer-reported performance data seem convincing, but real-world data are missing. Methods We retrospectively analysed all prospectively collected antigen tests results performed between 23.06.2020 and 26.11.2020, generated by non-laboratory personnel at the point-of-care from oro- or nasopharyngeal swab samples at the University Hospital Augsburg and compared them to concomitantly (within 24 h.) generated results from molecular tests. Results For a total of 3630 antigen tests, 3110 NAAT results were available. Overall, sensitivity, specificity, NPV and PPV of antigen testing were 59.4%, 99.0%, 98.7% and 64.8%, respectively. Sensitivity and PPV were lower in asymptomatic patients (47.6% and 44.4%, respectively) and only slightly higher in patients with clinical symptoms (66.7% and 85.0%, respectively). Some samples with very low Ct-values (minimum Ct 13) were not detected by antigen testing. 31 false positive results occurred. ROC curve analysis showed that reducing the COI cut-off from 1, as suggested by the manufacturer, to 0.9 is optimal, albeit with an AUC of only 0.66. Conclusion In real life, performance of lateral-flow-based antigen tests are well below the manufacturer's specifications, irrespective of patient’s symptoms. Their use for detection of individual patients infected with SARS-CoV2 should be discouraged. This does not preclude their usefulness in large-scale screening programs to reduce transmission events on a population-wide scale.

Defending Lawsuits

2018 ◽  
Author(s):  
Scott Burris ◽  
Micah L. Berman ◽  
Matthew Penn, and ◽  
Tara Ramanathan Holiday
Keyword(s):  
Public Health ◽  
Federal Government ◽  
Technical Assistance ◽  
Health Law ◽  
Tobacco Company ◽  
Amicus Curiae ◽  
Health Organizations ◽  
Public Health Organizations ◽  
Health Laws

Chapter 20 explores the strategic reasons why entities may challenge public health laws, and uses the R.J. Reynolds Tobacco Company v. FDA case to walk through the steps of a legal challenge to a public health law. The chapter also identifies the attorneys involved in defending public health laws on behalf of local, state, and federal government entities and explains how legal technical assistance from public health organizations can support their efforts. Finally, the chapter defines the role of amicus curiae briefs and how they may effectively contribute to the defense of public health laws and regulations.

Variations in the Form and Services of Public Health Organizations

1938 ◽  
Vol 53 (14) ◽  
pp. 523 ◽  
Author(s):  
Joseph W. Mountin ◽  
Anthony J. Borowski ◽  
Hazel O'Hara
Keyword(s):  
Public Health ◽  
Health Organizations ◽  
Public Health Organizations

Communicating a Scientific Story

2021 ◽  
pp. 002203452110493
Author(s):  
M. Jacob
Keyword(s):  
Public Health ◽  
Oral Health ◽  
Scientific Literature ◽  
Early 20Th Century ◽  
Health Organizations ◽  
Policy Makers ◽  
Health Community ◽  
Public Health Organizations ◽  
Research Findings ◽  
Interesting Story

Public health organizations typically try to raise literacy or counter misinformation with fact sheets and other data-centric messages. Yet research shows that disseminating more information does not necessarily combat myths. Storytelling offers the oral health community another option for engaging audiences and complementing the facts. The early–20th century research into fluoride is one example of an interesting story. Data and stories can complement each other. Using the elements of storytelling to report or summarize research findings could make such findings more relevant to health policy makers, whose decisions are often driven by values and evidence. Although the scientific literature has not produced a definitive template for instilling stories in a study manuscript, I provide several techniques and caveats for oral health researchers to consider.

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