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Article: The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses.

Kost, Gerald J

2023 Volume 13, Issue 20

Abstract: A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, ... ...

Abstract	A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, R
Language	English
Publishing date	2023-10-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics13203223
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The COVID-19 Grand Challenge: Setting Expectations and Future Directions for Community and Home Testing.

Kost, Gerald J

Archives of pathology & laboratory medicine

2022 Volume 146, Issue 7, Page(s) 789–790

MeSH term(s)	COVID-19 ; COVID-19 Testing ; Humans ; Motivation
Language	English
Publishing date	2022-03-24
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2022-0037-LE
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Article: The Coronavirus Disease 2019 Spatial Care Path: Home, Community, and Emergency Diagnostic Portals.

Kost, Gerald J

Diagnostics (Basel, Switzerland)

2022 Volume 12, Issue 5

Abstract: This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, ... ...

Abstract	This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, community, and emergency spatial care paths. Mathematica and open access software helped graph relationships, compare performance patterns, and perform recursive computations. Tiered sensitivity/specificity comprise: (T1) 90%/95%; (T2) 95%/97.5%; and (T3) 100%/≥99%, respectively. In emergency medicine, median RAgT performance peaks at 13.2% prevalence, then falls below T1, generating risky prevalence boundaries. RAgTs in pediatric ERs/EDs parallel this pattern with asymptomatic worse than symptomatic performance. In communities, RAgTs display large uncertainty with median prevalence boundary of 14.8% for 1/20 missed diagnoses, and at prevalence > 33.3−36.9% risk 10% false omissions for symptomatic subjects. Recursive testing improves home RAgT performance. Home molecular tests elevate performance above T1 but lack adequate validation. Widespread RAgT availability encourages self-testing. Asymptomatic RAgT and PCR-based saliva testing present the highest chance of missed diagnoses. Home testing twice, once just before mingling, and molecular-based self-testing, help avoid false omissions. Community and ER/ED RAgTs can identify contagiousness in low prevalence. Real-world trials of performance, cost-effectiveness, and public health impact could identify home molecular diagnostics as an optimal diagnostic portal.
Language	English
Publishing date	2022-05-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics12051216
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Article ; Online: Home Antigen Test Recall Affects Millions: Beware False Positives, but Also Uncertainty and Potential False Negatives.

Kost, Gerald J

Archives of pathology & laboratory medicine

2021 Volume 146, Issue 4, Page(s) 403

MeSH term(s)	False Negative Reactions ; False Positive Reactions ; Humans ; Uncertainty
Language	English
Publishing date	2021-12-29
Publishing country	United States
Document type	Letter
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2021-0563-LE
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Article ; Online: Public Health Education Should Include Point-of-Care Testing: Lessons Learned from the Covid-19 Pandemic.

Kost, Gerald J

EJIFCC

2021 Volume 32, Issue 3, Page(s) 311–327

Abstract: Goal: The goal is to present key principles of point-of-care testing (POCT) in educational curricula that meet critical needs for rapid decision-making in disasters, outbreaks of highly infectious diseases, emergency management, and complex crises.: ... ...

Abstract	Goal: The goal is to present key principles of point-of-care testing (POCT) in educational curricula that meet critical needs for rapid decision-making in disasters, outbreaks of highly infectious diseases, emergency management, and complex crises. Observations: The coronavirus disease 19 (COVID-19) pandemic unequivocally proved the value of POC strategies. Striking needs identified by COVID-19 challenges have yet to be entirely fulfilled. A comprehensive national survey showed absence of POCT training in public health colleges, schools, and programs. Fundamental improvements in national structuring of POC knowledge, skills, experience, training, dissemination, accreditation, and licensing are necessary, so that multidisciplinary public health teams can respond effectively and efficiently by geospatially optimizing the control and mitigation of highly infectious diseases and other critical challenges. Conclusions: Four sets of POCT learning objectives were developed for public health and other educational institutions. Global implementation of POC diagnostics in the hands of trained personnel will help avoid untimely worldwide crises, huge economic losses, uncounted excess mortality, and sudden disruptive surges of dangerous infectious threats to personal security and cultural stability.
Language	English
Publishing date	2021-10-18
Publishing country	Italy
Document type	Journal Article
ISSN	1650-3414
ISSN (online)	1650-3414
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Diagnostic Strategies for Endemic Coronavirus Disease 2019 (COVID-19).

Kost, Gerald J

Archives of pathology & laboratory medicine

2021 Volume 146, Issue 1, Page(s) 16–25

Abstract: Context.—: Coronavirus disease 2019 (COVID-19) rapid antigen tests generate intrinsically fast, inherently spatial, and immediately actionable results. They quickly confirm COVID-19, but weakly rule out infection. Test performance depends on prevalence ... ...

Abstract	Context.—: Coronavirus disease 2019 (COVID-19) rapid antigen tests generate intrinsically fast, inherently spatial, and immediately actionable results. They quickly confirm COVID-19, but weakly rule out infection. Test performance depends on prevalence and testing protocol. Both affect predictive values. Objectives.—: To use original mathematics and visual logistics for interpreting COVID-19 rapid antigen test performance patterns, gauge the influence of prevalence, and evaluate repeated testing. Design.—: Mathematica and open access software helped graph relationships, perform recursive computations, and compare performance patterns. PubMed retrieved articles addressing endemic COVID-19 were reviewed. Results.—: Tiered sensitivity/specificity comprise the following: T1 (90%/95%), T2 (95%/97.5%), and T3 (100%/≥99%). Performance of self-tests and home antigen tests with US Food and Drug Administration Emergency Use Authorization peaks in low prevalence. Fall-off in performance appears with increasing prevalence because suboptimal sensitivity creates false negatives. The rate of false omissions limits clinical use because of prevalence boundaries based on tolerance for risk. Mathematical analysis supports testing twice to improve predictive values and extend prevalence boundaries nearly to levels of herd immunity. Conclusions.—: COVID-19 is quickly becoming endemic. Suboptimal sensitivity of rapid antigen tests limits performance in high prevalence. Risk of contagion in packed spaces (eg, airplanes) might be avoided with dual testing 36 hours apart, allowing time for viral load to increase. Awareness of community prevalence and proof of improved performance with repeated testing will help manage COVID-19 risk, while meeting rapid decision-making needs for highly contagious and new variants (eg, Delta). New COVID-19 variants call for high-quality, low cost, readily accessible, fast, user friendly, and ubiquitous point-of-care testing.
MeSH term(s)	COVID-19 ; COVID-19 Testing ; Humans ; SARS-CoV-2 ; Sensitivity and Specificity
Language	English
Publishing date	2021-10-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2021-0386-SA
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Article ; Online: The Impact of Increasing Disease Prevalence, False Omissions, and Diagnostic Uncertainty on Coronavirus Disease 2019 (COVID-19) Test Performance.

Kost, Gerald J

Archives of pathology & laboratory medicine

2021 Volume 145, Issue 7, Page(s) 797–813

Abstract: Context.—: Coronavirus disease 2019 (COVID-19) test performance depends on predictive values in settings of increasing disease prevalence. Geospatially distributed diagnostics with minimal uncertainty facilitate efficient point-of-need strategies.: ... ...

Abstract	Context.—: Coronavirus disease 2019 (COVID-19) test performance depends on predictive values in settings of increasing disease prevalence. Geospatially distributed diagnostics with minimal uncertainty facilitate efficient point-of-need strategies. Objectives.—: To use original mathematics to interpret COVID-19 test metrics; assess US Food and Drug Administration Emergency Use Authorizations and Health Canada targets; compare predictive values for multiplex, antigen, polymerase chain reaction kit, point-of-care antibody, and home tests; enhance test performance; and improve decision-making. Design.—: PubMed/newsprint-generated articles documenting prevalence. Mathematica and open access software helped perform recursive calculations, graph multivariate relationships, and visualize performance by comparing predictive value geometric mean-squared patterns. Results.—: Tiered sensitivity/specificity comprised: T1, 90%, 95%; T2, 95%, 97.5%; and T3, 100%, ≥99%. Tier 1 false negatives exceeded true negatives at >90.5% prevalence; false positives exceeded true positives at <5.3% prevalence. High-sensitivity/specificity tests reduced false negatives and false positives, yielding superior predictive values. Recursive testing improved predictive values. Visual logistics facilitated test comparisons. Antigen test quality fell off as prevalence increased. Multiplex severe acute respiratory syndrome (SARS)-CoV-2)influenza A/Brespiratory syncytial virus testing performed reasonably well compared with tier 3. Tier 3 performance with a tier 2 confidence band lower limit will generate excellent performance and reliability. Conclusions.—: The overriding principle is to select the best combined performance and reliability pattern for the prevalence bracket. Some public health professionals recommend repetitive testing to compensate for low sensitivity. More logically, improved COVID-19 assays with less uncertainty conserve resources. Multiplex differentiation of COVID-19 from influenza A/B-respiratory syncytial virus represents an effective strategy if seasonal flu surges next year.
MeSH term(s)	COVID-19/diagnosis ; COVID-19/epidemiology ; COVID-19 Testing/methods ; COVID-19 Testing/standards ; Canada/epidemiology ; False Negative Reactions ; False Positive Reactions ; Humans ; Point-of-Care Systems/standards ; Predictive Value of Tests ; Prevalence ; Reproducibility of Results ; Sensitivity and Specificity ; Uncertainty ; United States/epidemiology
Language	English
Publishing date	2021-03-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2020-0716-SA
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Article ; Online: Geospatial Spread of Antimicrobial Resistance, Bacterial and Fungal Threats to Coronavirus Infectious Disease 2019 (COVID-19) Survival, and Point-of-Care Solutions.

Kost, Gerald J

Archives of pathology & laboratory medicine

2021 Volume 145, Issue 2, Page(s) 145–167

Abstract: Context.—: Point-of-care testing (POCT) is inherently spatial, that is, performed where needed, and intrinsically temporal, because it accelerates decision-making. POCT efficiency and effectiveness have the potential to facilitate antimicrobial ... ...

Abstract	Context.—: Point-of-care testing (POCT) is inherently spatial, that is, performed where needed, and intrinsically temporal, because it accelerates decision-making. POCT efficiency and effectiveness have the potential to facilitate antimicrobial resistance (AMR) detection, decrease risks of coinfections for critically ill patients with coronavirus infectious disease 2019 (COVID-19), and improve the cost-effectiveness of health care. Objectives.—: To assess AMR identification by using POCT, describe the United States AMR Diagnostic Challenge, and improve global standards of care for infectious diseases. Data sources.—: PubMed, World Wide Web, and other sources were searched for papers focusing on AMR and POCT. EndNote X9.1 (Clarivate Analytics) consolidated abstracts, URLs, and PDFs representing approximately 500 articles were assessed for relevance. Panelist insights at Tri•Con 2020 in San Francisco and finalist POC technologies competing for a US $20,000,000 AMR prize are summarized. Conclusions.—: Coinfections represent high risks for COVID-19 patients. POCT potentially will help target specific pathogens, refine choices for antimicrobial drugs, and prevent excess morbidity and mortality. POC assays that identify patterns of pathogen resistance can help tell us how infected individuals spread AMR, where geospatial hotspots are located, when delays cause death, and how to deploy preventative resources. Shared AMR data "clouds" could help reduce critical care burden during pandemics and optimize therapeutic options, similar to use of antibiograms in individual hospitals. Multidisciplinary health care personnel should learn the principles and practice of POCT, so they can meet needs with rapid diagnostic testing. The stakes are high. Antimicrobial resistance is projected to cause millions of deaths annually and cumulative financial loses in the trillions by 2050.
MeSH term(s)	Awards and Prizes ; Bacterial Infections/diagnosis ; Bacterial Infections/microbiology ; COVID-19/diagnosis ; COVID-19/microbiology ; COVID-19/mortality ; Coinfection/diagnosis ; Coinfection/microbiology ; Drug Resistance, Bacterial ; Drug Resistance, Fungal ; Humans ; Microbial Sensitivity Tests/methods ; Microbial Sensitivity Tests/standards ; Mycoses/diagnosis ; Mycoses/microbiology ; Point-of-Care Systems/standards ; Spatial Analysis ; United States/epidemiology
Keywords	covid19
Language	English
Publishing date	2021-06-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2020-0284-RA
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Article ; Online: The Coronavirus Disease 2019 Spatial Care Path

Gerald J. Kost

Diagnostics, Vol 12, Iss 1216, p

Home, Community, and Emergency Diagnostic Portals

2022 Volume 1216

Abstract	This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, community, and emergency spatial care paths. Mathematica and open access software helped graph relationships, compare performance patterns, and perform recursive computations. Tiered sensitivity/specificity comprise: (T1) 90%/95%; (T2) 95%/97.5%; and (T3) 100%/≥99%, respectively. In emergency medicine, median RAgT performance peaks at 13.2% prevalence, then falls below T1, generating risky prevalence boundaries. RAgTs in pediatric ERs/EDs parallel this pattern with asymptomatic worse than symptomatic performance. In communities, RAgTs display large uncertainty with median prevalence boundary of 14.8% for 1/20 missed diagnoses, and at prevalence > 33.3–36.9% risk 10% false omissions for symptomatic subjects. Recursive testing improves home RAgT performance. Home molecular tests elevate performance above T1 but lack adequate validation. Widespread RAgT availability encourages self-testing. Asymptomatic RAgT and PCR-based saliva testing present the highest chance of missed diagnoses. Home testing twice, once just before mingling, and molecular-based self-testing, help avoid false omissions. Community and ER/ED RAgTs can identify contagiousness in low prevalence. Real-world trials of performance, cost-effectiveness, and public health impact could identify home molecular diagnostics as an optimal diagnostic portal.
Keywords	Emergency Use Authorization (EUA) ; endemic ; false omission rate (R FO ) ; home testing ; point-of-care testing (POCT) ; positive predictive value geometric mean-squared (PV GM 2 ) ; Medicine (General) ; R5-920
Subject code	360
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Commutable Blood Materials from the Fixed-Cell Method for Performance Evaluation of Blood Glucose by a Glucose Meter.

Apiratmateekul, Napaporn / Nammoonnoy, Jintana / Kost, Gerald J / Treebuphachatsakul, Wanvisa

Diagnostics (Basel, Switzerland)

2024 Volume 14, Issue 8

Abstract: Glucose meters provide a rapid blood glucose status for evidence-based diagnosis, monitoring, and treatment of diabetes mellitus. We aimed to evaluate the commutability of processed blood materials (PBMs) and their use in the performance evaluation of ... ...

Abstract	Glucose meters provide a rapid blood glucose status for evidence-based diagnosis, monitoring, and treatment of diabetes mellitus. We aimed to evaluate the commutability of processed blood materials (PBMs) and their use in the performance evaluation of glucose meters. Two PBMs obtained by the fixed-cell method were analyzed for homogeneity, stability, and commutability. The compatibility of ten pairs between mass spectrometry and each glucose meter was categorized as compatible (mean paired difference ≤ 5%) and incompatible (mean paired difference > 5%). The performance of glucose meter 1 (
Language	English
Publishing date	2024-04-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics14080799
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