Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study

Badnjević, Almir; Pokvić, Lejla Gurbeta; Džemić, Zijad; Bečić, Fahir

doi:10.1186/s12938-020-00820-0

Cited by 77 publications

(24 citation statements)

References 9 publications

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“…An important challenge concerning cleaning and reliable data is denoted. Finally, a recent study related to risks of emergency use authorizations for medical products during outbreak situations states the limitation regarding the need for an evidence-based regulatory framework [ 36 ].…”

Section: Resultsmentioning

confidence: 99%

Telemedicine and e-Health research solutions in literature for combatting COVID-19: a systematic review

et al. 2021

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COVID-19 had led to severe clinical manifestations. In the current scenario, 98 794 942 people are infected, and it has responsible for 2 124 193 deaths around the world as reported by World Health Organization on 25 January 2021. Telemedicine has become a critical technology for providing medical care to patients by trying to reduce transmission of the virus among patients, families, and doctors. The economic consequences of coronavirus have affected the entire world and disrupted daily life in many countries. The development of telemedicine applications and eHealth services can significantly help to manage pandemic worldwide better. Consequently, the main objective of this paper is to present a systematic review of the implementation of telemedicine and e-health systems in the combat to COVID-19. The main contribution is to present a comprehensive description of the state of the art considering the domain areas, organizations, funding agencies, researcher units and authors involved. The results show that the United States and China have the most significant number of studies representing 42.11% and 31.58%, respectively. Furthermore, 35 different research units and 9 funding agencies are involved in the application of telemedicine systems to combat COVID-19.

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Section: Resultsmentioning

confidence: 99%

Telemedicine and e-Health research solutions in literature for combatting COVID-19: a systematic review

et al. 2021

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“…Commercial manufacturers were required to submit a completed EUA request [ 22 ]. Unfortunately, the rush to market introduced many tests that did not meet typical US or international standards [ 37 ]. Therefore, the FDA and international regulatory agencies continue to update guidelines for authorization of new serological tests.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

et al. 2021

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Background COVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed. Methods We evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays’ performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10–40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence. Results Combined IgG + IgM sensitivities ranged from 33.9 to 94.6%, while combined specificities ranged from 92.6 to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG + IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG + IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek. Conclusion We provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.

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“…Commercial manufacturers were required to submit a completed EUA request 30 . Unfortunately, the rush to market introduced many tests that did not meet typical US or international standards 47 . Therefore, the FDA and international regulatory agencies continue to update guidelines for authorization of new serological tests.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

Trombetta¹,

Kandigian²,

Kitchen³

et al. 2021

Preprint

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BackgroundCOVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed.MethodsWe evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays’ performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10-40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence.ResultsCombined IgG+IgM sensitivities ranged from 33.9% to 94.6%, while combined specificities ranged from 92.6% to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG+IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG+IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek.ConclusionWe provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.

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Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study

Cited by 77 publications

References 9 publications

Telemedicine and e-Health research solutions in literature for combatting COVID-19: a systematic review

Telemedicine and e-Health research solutions in literature for combatting COVID-19: a systematic review

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

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