“… 21 , 22 Early identification of these hidden individuals before they can further transmit SARS‐CoV‐2 to other susceptible people can have a very large positive impact on the development of surge epidemics. For this purpose, the use of POC‐based real‐time RT‐PCR tests in addition to the conventional‐type platform may provide rapid, sensitive, and specific SARS‐CoV‐2 detection, 23 and the pooled‐specimen screening strategy is an effective way to increase testing capacity and save substantial resources, making laboratory diagnosis sustainable. 24 …”
Background
The rapid identification and isolation of individuals infected with SARS‐CoV‐2 are fundamental countermeasures for the efficient control of the COVID‐19 pandemic, which has affected millions of people around the world. Real‐time RT‐PCR is one of the most commonly applied reference methods for virus detection, and the use of pooled testing has been proposed as an effective way to increase the throughput of routine diagnostic tests. However, the clinical applicability of different types of real‐time RT‐PCR tests in a given group size remains inconclusive due to inconsistent regional disease prevalence and test demands.
Methods
In this study, the performance of one dual‐target conventional and two point‐of‐care real‐time RT‐PCR tests in a 5‐specimen pooled testing strategy for the detection of SARS‐COV‐2 was evaluated.
Results
We demonstrated the proof of concept that all of these real‐time RT‐PCR tests could feasibly detect SARS‐CoV‐2 from nasopharyngeal and oropharyngeal specimens that contain viral RNA loads in the range of 3.48 × 10
5
to 3.42 × 10
2
copies/ml through pooled testing in a group size of 5 with overall positive percent agreement (pooling vs. individual testing) ranging from 100% to 93.75%. Furthermore, the two POC real‐time RT‐PCR tests exhibited comparable sensitivity to that of the dual‐target conventional one when clinical specimens were tested individually.
Conclusion
Our findings support the feasibility of using real‐time RT‐PCR tests developed as a variety of platforms in routine laboratory detection of suspected COVID‐19 cases through a pooled testing strategy that is beneficial to increasing the daily diagnostic capacity.
“… 21 , 22 Early identification of these hidden individuals before they can further transmit SARS‐CoV‐2 to other susceptible people can have a very large positive impact on the development of surge epidemics. For this purpose, the use of POC‐based real‐time RT‐PCR tests in addition to the conventional‐type platform may provide rapid, sensitive, and specific SARS‐CoV‐2 detection, 23 and the pooled‐specimen screening strategy is an effective way to increase testing capacity and save substantial resources, making laboratory diagnosis sustainable. 24 …”
Background
The rapid identification and isolation of individuals infected with SARS‐CoV‐2 are fundamental countermeasures for the efficient control of the COVID‐19 pandemic, which has affected millions of people around the world. Real‐time RT‐PCR is one of the most commonly applied reference methods for virus detection, and the use of pooled testing has been proposed as an effective way to increase the throughput of routine diagnostic tests. However, the clinical applicability of different types of real‐time RT‐PCR tests in a given group size remains inconclusive due to inconsistent regional disease prevalence and test demands.
Methods
In this study, the performance of one dual‐target conventional and two point‐of‐care real‐time RT‐PCR tests in a 5‐specimen pooled testing strategy for the detection of SARS‐COV‐2 was evaluated.
Results
We demonstrated the proof of concept that all of these real‐time RT‐PCR tests could feasibly detect SARS‐CoV‐2 from nasopharyngeal and oropharyngeal specimens that contain viral RNA loads in the range of 3.48 × 10
5
to 3.42 × 10
2
copies/ml through pooled testing in a group size of 5 with overall positive percent agreement (pooling vs. individual testing) ranging from 100% to 93.75%. Furthermore, the two POC real‐time RT‐PCR tests exhibited comparable sensitivity to that of the dual‐target conventional one when clinical specimens were tested individually.
Conclusion
Our findings support the feasibility of using real‐time RT‐PCR tests developed as a variety of platforms in routine laboratory detection of suspected COVID‐19 cases through a pooled testing strategy that is beneficial to increasing the daily diagnostic capacity.
“… 23 This commercialization culture in academia drives researchers to bring microfluidic solutions from lab to market to tackle real-world problems, 29 such as the rapid diagnosis of SARS-CoV-2 virus. 30 Meanwhile, plenty of academic spin-offs have been established based on the innovative character of their technology, such as Stilla Technologies from the laboratory of hydrodynamics (LadHyX) at Ecole Polytechnique, 31 Fluid-Screen from Yale University, 32 and BluSense Diagnostics from Technical University of Denmark. 33 These activities have confirmed the increasing popularity of academic entrepreneurship among higher education institutions worldwide.…”
Section: Challenges In Scale-up Fabricationmentioning
Transforming lab research into a sustainable business is becoming a trend in the microfluidic field. However, there are various challenges during the translation process due to the gaps between academia and industry, especially from laboratory prototyping to industrial scale-up production, which is critical for potential commercialization. In this Perspective, based on our experience in collaboration with stakeholders, e.g., biologists, microfluidic engineers, diagnostic specialists, and manufacturers, we aim to share our understanding of the manufacturing process chain of microfluidic cartridge from concept development and laboratory prototyping to scale-up production, where the scale-up production of commercial microfluidic cartridges is highlighted. Four suggestions from the aspect of cartridge design for manufacturing, professional involvement, material selection, and standardization are provided in order to help scientists from the laboratory to bring their innovations into pre-clinical, clinical, and mass production and improve the manufacturability of laboratory prototypes toward commercialization.
“…From sample preparation to the assay protocol, it usually requires a few hours [ 131 ]. To meet the diagnostic demands of the infectious pathogens, especially in those resource-limited settings, there is an urgent need for portable and integrated microfluidic platforms or micro/nano devices that can provide fast, accurate and even multiplex diagnosis at the point-of-care [ 132 ]. Figure 3 Micro/nano devices for nucleic acid testing.…”
Section: Micro/nano Devices For Point-of-care Testing Of Sars-cov-2mentioning
Corona Virus Disease 2019 (COVID-19) has developed into a global pandemic in the last two years, causing significant impacts on our daily life in many countries. Rapid and accurate detection of COVID-19 is of great importance to both treatments and pandemic management. Till now, a variety of point-of-care testing (POCT) approaches devices, including nucleic acid-based test and immunological detection, have been developed and some of them has been rapidly ruled out for clinical diagnosis of COVID-19 due to the requirement of mass testing. In this review, we provide a summary and commentary on the methods and biomedical devices innovated or renovated for the quick and early diagnosis of COVID-19. In particular, some of micro and nano devices with miniaturized structures, showing outstanding analytical performances such as ultra-sensitivity, rapidness, accuracy and low cost, are discussed in this paper. We also provide our insights on the further implementation of biomedical devices using advanced micro and nano technologies to meet the demand of point-of-care diagnosis and home testing to facilitate pandemic management. In general, our paper provides a comprehensive overview of the latest advances on the POCT device for diagnosis of COVID-19, which may provide insightful knowledge for researcher to further develop novel diagnostic technologies for rapid and on-site detection of pathogens including SARS-CoV-2.
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