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      Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

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          Abstract

          COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

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          Most cited references36

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          Point-of-care diagnostics for infectious diseases: From methods to devices

          The current widespread of COVID-19 all over the world, which is caused by SARS-CoV-2 virus, has again emphasized the importance of development of point-of-care (POC) diagnostics for timely prevention and control of the pandemic. Compared with labor- and time-consuming traditional diagnostic methods, POC diagnostics exhibit several advantages such as faster diagnostic speed, better sensitivity and specificity, lower cost, higher efficiency and ability of on-site detection. To achieve POC diagnostics, developing POC detection methods and correlated POC devices is the key and should be given top priority. The fast development of microfluidics, micro electro-mechanical systems (MEMS) technology, nanotechnology and materials science, have benefited the production of a series of portable, miniaturized, low cost and highly integrated POC devices for POC diagnostics of various infectious diseases. In this review, various POC detection methods for the diagnosis of infectious diseases, including electrochemical biosensors, fluorescence biosensors, surface-enhanced Raman scattering (SERS)-based biosensors, colorimetric biosensors, chemiluminiscence biosensors, surface plasmon resonance (SPR)-based biosensors, and magnetic biosensors, were first summarized. Then, recent progresses in the development of POC devices including lab-on-a-chip (LOC) devices, lab-on-a-disc (LOAD) devices, microfluidic paper-based analytical devices (μPADs), lateral flow devices, miniaturized PCR devices, and isothermal nucleic acid amplification (INAA) devices, were systematically discussed. Finally, the challenges and future perspectives for the design and development of POC detection methods and correlated devices were presented. The ultimate goal of this review is to provide new insights and directions for the future development of POC diagnostics for the management of infectious diseases and contribute to the prevention and control of infectious pandemics like COVID-19.
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            Limits of Detection of Six Approved RT–PCR Kits for the Novel SARS-coronavirus-2 (SARS-CoV-2)

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              Point-of-care testing detection methods for COVID-19

              This paper summarises the latest research advances and commercial products in POCT-based SARS-CoV-2 detection methods. COVID-19 is an acute respiratory disease caused by SARS-CoV-2, which has high transmissibility. People infected with SARS-CoV-2 can develop symptoms including cough, fever, pneumonia and other complications, which in severe cases could lead to death. In addition, a proportion of people infected with SARS-CoV-2 may be asymptomatic. At present, the primary diagnostic method for COVID-19 is reverse transcription-polymerase chain reaction (RT-PCR), which tests patient samples including nasopharyngeal swabs, sputum and other lower respiratory tract secretions. Other detection methods, e.g. , isothermal nucleic acid amplification, CRISPR, immunochromatography, enzyme-linked immunosorbent assay (ELISA) and electrochemical sensors are also in use. As the current testing methods are mostly performed at central hospitals and third-party testing centres, the testing systems used mostly employ large, high-throughput, automated equipment. Given the current situation of the epidemic, point-of-care testing (POCT) is advantageous in terms of its ease of use, greater approachability on the user's end, more timely detection, and comparable accuracy and sensitivity, which could reduce the testing load on central hospitals. POCT is thus conducive to daily epidemic control and achieving early detection and treatment. This paper summarises the latest research advances in POCT-based SARS-CoV-2 detection methods, compares three categories of commercially available products, i.e. , nucleic acid tests, immunoassays and novel sensors, and proposes the expectations for the development of POCT-based SARS-CoV-2 detection including greater accessibility, higher sensitivity and lower costs.
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                Author and article information

                Contributors
                Journal
                Front Cell Infect Microbiol
                Front Cell Infect Microbiol
                Front. Cell. Infect. Microbiol.
                Frontiers in Cellular and Infection Microbiology
                Frontiers Media S.A.
                2235-2988
                13 October 2021
                2021
                13 October 2021
                : 11
                : 755508
                Affiliations
                [1] 1 Pediatric Translational Medicine Institute, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University , Shanghai, China
                [2] 2 Department of Molecular Biology, Shanghai Centre for Clinical Laboratory , Shanghai, China
                [3] 3 Department of Laboratory Medicine, Shanghai Public Health Clinical Center, Fudan University , Shanghai, China
                [4] 4 Department of Critical Care Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University , Shanghai, China
                [5] 5 Department of Laboratory Medicine, Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center , Shanghai, China
                [6] 6 Department of Infectious Diseases, Research Laboratory of Clinical Virology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University , Shanghai, China
                [7] 7 Department of Laboratory Medicine, Shanghai Tongji Hospital, School of Medicine, Tongji University , Shanghai, China
                [8] 8 Department of Clinical Laboratory Medicine, Shanghai Tenth People’s Hospital of Tongji University , Shanghai, China
                [9] 9 Department of Laboratory Medicine, Changzheng Hospital, Naval Medical University , Shanghai, China
                [10] 10 Department of Clinical Laboratory, Children’s Hospital of Fudan University , Shanghai, China
                [11] 11 Department of Clinical Laboratory, Shanghai Children’s Hospital , Shanghai, China
                [12] 12 Clinical Laboratory Medicine Center, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai , Shanghai, China
                [13] 13 Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University , Shanghai, China
                [14] 14 Department of Laboratory Medicine, Shanghai East Hospital, Tongji University School of Medicine , Shanghai, China
                Author notes

                Edited by: Sherry Dunbar, Luminex, United States

                Reviewed by: Shubhagata Das, Luminex, United States; Ted Schutzbank, Agena Bioscience, United States

                *Correspondence: Wenjuan Wu, wwj1210@ 123456126.com ; Yanqun Xiao, xiaoyanqun@ 123456sccl.org.cn ; Ming Guan, guanming@ 123456shmu.edu.cn ; Chunfang Gao, gaocf1115@ 123456163.com

                †These authors have contributed equally to this work

                This article was submitted to Clinical Microbiology, a section of the journal Frontiers in Cellular and Infection Microbiology

                Article
                10.3389/fcimb.2021.755508
                8548827
                c12d4ee8-2cc3-47d2-956b-26c62c580406
                Copyright © 2021 Mo, Wang, Zhu, Yu, Chang, Zhang, Li, Sun, Zhou, Xu, Zhang, Gao, Guan, Xiao and Wu

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 09 August 2021
                : 28 September 2021
                Page count
                Figures: 0, Tables: 2, Equations: 0, References: 37, Pages: 9, Words: 5247
                Categories
                Cellular and Infection Microbiology
                Review

                Infectious disease & Microbiology
                pathogen,nucleic acid,point-of-care testing,expert consensus,whole-process operation management

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