Point of care molecular and antigen detection tests for COVID-19: current status and future prospects

Stokes, William; Berenger, Byron M.; Venner, Allison A.; Deslandes, Vincent; Shaw, Julie

doi:10.1080/14737159.2022.2122712

Cited by 6 publications

(5 citation statements)

References 89 publications

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“…Although LFIA-based rapid test kits can fulfill the criteria for POCT, it still confronts some challenges such as improved sensitivity, poor stability and inability to detect nucleic acids [ 29 ]. Similarly, NAAT-based SARS-CoV-2 POCT tends to be used in healthcare settings rather than for self-testing [ 183 ]. Accordingly, novel ideas for better use in SARS-CoV-2 POCT have been proposed.…”

Section: Rapid Detection Methodsmentioning

confidence: 99%

Rapid assays of SARS-CoV-2 virus and noble biosensors by nanomaterials

Liu,

Li,

Hang

et al. 2024

Nano Convergence

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The COVID-19 outbreak caused by SARS-CoV-2 in late 2019 has spread rapidly across the world to form a global epidemic of respiratory infectious diseases. Increased investigations on diagnostic tools are currently implemented to assist rapid identification of the virus because mass and rapid diagnosis might be the best way to prevent the outbreak of the virus. This critical review discusses the detection principles, fabrication techniques, and applications on the rapid detection of SARS-CoV-2 with three categories: rapid nuclear acid augmentation test, rapid immunoassay test and biosensors. Special efforts were put on enhancement of nanomaterials on biosensors for rapid, sensitive, and low-cost diagnostics of SARS-CoV-2 virus. Future developments are suggested regarding potential candidates in hospitals, clinics and laboratories for control and prevention of large-scale epidemic. Graphical Abstract

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Section: Rapid Detection Methodsmentioning

confidence: 99%

Rapid assays of SARS-CoV-2 virus and noble biosensors by nanomaterials

Liu,

Li,

Hang

et al. 2024

Nano Convergence

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“…The market size for POC diagnostics grew exponentially in both size and value during this period [ 26 ], with significant investments towards the development of new platforms. These investments spurred innovation at a pace never seen before and revolutionized the true-POC technology landscape [ 27 , 28 ]. Molecular detection methods that can now be integrated into miniaturized battery-powered platforms have expanded the use of nucleic acid amplification testing to nonclinical settings, and even in the home.…”

Section: True Point-of-care Testing Platforms That Could Potentially ...mentioning

confidence: 99%

Molecular Point-of-Care Testing for Hepatitis C: Available Technologies, Pipeline, and Promising Future Directions

Ivanova Reipold,

Shilton,

Donolato

et al. 2023

The Journal of Infectious Diseases

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Hepatitis C (HCV) remains a major public health problem, despite the availability of effective treatments. In many areas, the ability to diagnose HCV infection at the point of care is key to scaling up access to care and treatment. To achieve this, an accurate, easy-to-use and affordable diagnostic tool is required – this would enable decentralized testing and the creation of one-stop centers to eliminate gaps in the care cascade, which would help reach the millions of people with undiagnosed HCV in low- and middle-income countries and high-risk populations in high income countries. In this review, we examine the current state of point-of-care molecular technologies, the advantages and limitations of currently available devices (both near- and true-point-of-care), the potential of molecular testing to transform diagnostic medicine in the future, and the challenges that need to be addressed for broader adoption of this technology in routine clinical practice.

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“…No precise temporal trend maps of COVID-19 prevalence in different countries are available for comparison, so the impact of prevalence, per se, is uncertain, although prevalence is known to have been very high in COVID-19 hotspots and high-risk settings [49]. Breaches of RAgT PBs may have generated vicious cycles, adversely transformed outbreaks into endemic disease, prolonged contagion, defeated mitigation, allowed new variants to arise, and fueled the pandemic, as Figure 3 and the prevalence boundary hypothesis [43] suggest.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

“…Use of RAgTs for COVID-19 or future highly infectious disease threats should be evidence-based [49]. COVID-19 was shown to have positivity rates and/or prevalence as high as 75% in California and Ohio prisons and in emergency rooms in Brooklyn, New York [50], which creates high potential for asymptomatic infections to spread silently.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

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

Kost

2023

Diagnostics

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A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, RFO = FN/(TN + FN), exceeds the tolerance limit for missed diagnoses. The objectives were to mathematically analyze rapid antigen test (RAgT) performance, determine why PBs are breeched, and evaluate the merits of testing three times over five days, now required by the US Food and Drug Administration for asymptomatic persons. Equations were derived to compare test performance patterns, calculate PBs, and perform recursive computations. An independent July 2023 FDA–NIH–university–commercial evaluation of RAgTs provided performance data used in theoretical calculations. Tiered sensitivity/specificity comprise the following: tier (1) 90%, 95%; tier (2) 95%, 97.5%; and tier (3) 100%, ≥99%. Repeating a T2 test improves the PB from 44.6% to 95.2% (RFO 5%). In the FDA–NIH-university–commercial evaluation, RAgTs generated a sensitivity of 34.4%, which improved to 55.3% when repeated, and then improved to 68.5% with the third test. With RFO = 5%, PBs are 7.37/10.46/14.22%, respectively. PB analysis suggests that RAgTs should achieve a clinically proven sensitivity of 91.0–91.4%. When prevalence exceeds PBs, missed diagnoses can perpetuate virus transmission. Repeating low-sensitivity RAgTs delays diagnosis. In homes, high-risk settings, and hotspots, PB breaches may prolong contagion, defeat mitigation, facilitate new variants, and transform outbreaks into endemic disease. Molecular diagnostics can help avoid these potential vicious cycles.

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Point of care molecular and antigen detection tests for COVID-19: current status and future prospects

Cited by 6 publications

References 89 publications

Rapid assays of SARS-CoV-2 virus and noble biosensors by nanomaterials

Rapid assays of SARS-CoV-2 virus and noble biosensors by nanomaterials

Molecular Point-of-Care Testing for Hepatitis C: Available Technologies, Pipeline, and Promising Future Directions

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

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