The Main Molecular and Serological Methods for Diagnosing COVID-19: An Overview Based on the Literature
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Shen, 2020, Recent advances and perspectives of nucleic acid detection for coronavirus, J. Pharm. Anal., 10, 97, 10.1016/j.jpha.2020.02.010
Younes, N., Al-Sadeq, D.W., AL-Jighefee, H., Younes, S., Al-Jamal, O., Daas, H.I., Yassine, H.M., and Nasrallah, G.K. (2020). Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2. Viruses, 12.
Falzarano, 2016, SARS and MERS: Recent insights into emerging coronaviruses, Nat. Rev. Microbiol., 14, 523, 10.1038/nrmicro.2016.81
Chatziprodromidou, 2018, Global avian influenza outbreaks 2010–2016: A systematic review of their distribution, avian species and virus subtype, Syst. Rev., 7, 17, 10.1186/s13643-018-0691-z
Weaver, 2015, Chikungunya virus and the global spread of a mosquito-borne disease, N. Engl. J. Med., 372, 1231, 10.1056/NEJMra1406035
WHO (2020, December 14). WHO Coronavirus Disease (COVID-19) Dashboard. Available online: https://covid19.who.int/.
Carter, 2020, Assay Techniques and Test Development for COVID-19 Diagnosis, ACS Cent. Sci., 6, 591, 10.1021/acscentsci.0c00501
Kaushik, 2020, The Indian perspective of COVID-19 outbreak, Virusdisease, 31, 146, 10.1007/s13337-020-00587-x
Wang, 2020, The genetic sequence, origin, and diagnosis of SARS-CoV-2, Eur. J. Clin. Microbiol. Infect. Dis., 39, 1629, 10.1007/s10096-020-03899-4
Romano, M., Ruggiero, A., Squeglia, F., Maga, G., and Berisio, R. (2020). A Structural View of SARS-CoV-2 RNA Replication Machinery: RNA Synthesis, Proofreading and Final Capping. Cells, 9.
Zhou, 2020, A pneumonia outbreak associated with a new coronavirus of probable bat origin, Nature, 579, 270, 10.1038/s41586-020-2012-7
Lu, 2020, Genomic characterisation and epidemiology of 2019 novel coronavirus: Implications for virus origins and receptor binding, Lancet, 395, 565, 10.1016/S0140-6736(20)30251-8
Huang, 2020, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, Lancet, 395, 497, 10.1016/S0140-6736(20)30183-5
Pang, J., Wang, M.X., Ang, I.Y.H., Tan, S.H.X., Lewis, R.F., Chen, J.I.-P., Gutierrez, R.A., Gwee, S.X.W., Chua, P.E.Y., and Yang, Q. (2020). Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review. J. Clin. Med., 9.
Zheng, 2020, SARS-CoV-2: An Emerging Coronavirus that Causes a Global Threat, Int. J. Biol. Sci., 2020, 1678, 10.7150/ijbs.45053
Zhang, 2020, Current development of COVID-19 diagnostics, vaccines and therapeutics, Microbes Infect., 22, 231, 10.1016/j.micinf.2020.05.001
Zhang, 2020, Wuhan and Hubei COVID-19 mortality analysis reveals the critical role of timely supply of medical resources, J. Infect., 81, 147, 10.1016/j.jinf.2020.03.018
MHRA (2020, December 09). COVID-19 Vaccination Programme, Available online: https://www.gov.uk/government/collections/covid-19-vaccination-programme.
Guglielmi, 2020, The explosion of new coronavirus tests that could help to end the pandemic, Nature, 583, 506, 10.1038/d41586-020-02140-8
Ritchie, H., Ortiz-Ospina, E., Beltekian, D., Mathieu, E., Hasell, J., Macdonald, B., Giattino, C., and Roser, M. (2020, September 29). Coronavirus (COVID-19) Testing—Statistics and Research. Available online: https://ourworldindata.org/coronavirus-testing#our-checklist-for-covid-19-testing-data.
Loeffelholz, 2020, Laboratory diagnosis of emerging human coronavirus infections–the state of the art, Emerg. Microbes Infect., 9, 747, 10.1080/22221751.2020.1745095
Jin, 2020, A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version), Mil. Med. Res., 7, 4
Zhang, 2020, Molecular and serological investigation of 2019-nCoV infected patients: Implication of multiple shedding routes, Emerg. Microbes Infect., 9, 386, 10.1080/22221751.2020.1729071
Yurdaisik, 2020, Effectiveness of Computed Tomography in the Diagnosis of Novel Coronavirus-2019, Cureus, 12, e8134
Ling, 2020, Asymptomatic SARS-CoV-2 infected patients with persistent negative CT findings, Eur. J. Radiol., 126, 108956, 10.1016/j.ejrad.2020.108956
Rashid, 2020, Diagnostic performance of COVID-19 serology assays, Malays. J. Pathol., 42, 13
WHO (2020). Coronavirus Disease (COVID-19) Technical Guidance: Laboratory Testing for 2019-nCoV in Humans, WHO.
CDC (2020, September 09). Real-Time RT-PCR Diagnostic Panel for Emergency Use Only, Available online: https://www.fda.gov/media/134922/download.
Wang, 2020, Combination of serological total antibody and RT-PCR test for detection of SARS-COV-2 infections, J. Virol. Methods, 283, 113919, 10.1016/j.jviromet.2020.113919
Ai, 2020, Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases, Radiology, 296, E32, 10.1148/radiol.2020200642
Lee, 2020, Interrupting transmission of COVID-19: Lessons from containment efforts in Singapore, J. Travel Med., 27, 1, 10.1093/jtm/taaa039
Song, 2020, Covid-19 in South Korea—Challenges of subclinical manifestations, N. Engl. J. Med., 382, 1858, 10.1056/NEJMc2001801
Ejazi, S.A., Ghosh, S., and Ali, N. (2020). Antibody detection assays for COVID-19 diagnosis: An early overview. Immunol. Cell Biol.
Anand, 2020, Prevalence of SARS-CoV-2 antibodies in a large nationwide sample of patients on dialysis in the USA: A cross-sectional study, Lancet, 396, 1335, 10.1016/S0140-6736(20)32009-2
Hallal, 2020, SARS-CoV-2 antibody prevalence in Brazil: Results from two successive nationwide serological household surveys, Lancet Glob. Health, 8, e1390, 10.1016/S2214-109X(20)30387-9
Murhekar, 2020, Prevalence of SARS-CoV-2 infection in India: Findings from the national serosurvey, May-June 2020, Indian J. Med. Res., 152, 48, 10.4103/ijmr.IJMR_3290_20
Legnardi, M., Tucciarone, C.M., Franzo, G., and Cecchinato, M. (2020). Infectious Bronchitis Virus Evolution, Diagnosis and Control. Vet. Sci., 7.
Zhang, 2020, Recent advances in the detection of respiratory virus infection in humans, J. Med. Virol., 92, 408, 10.1002/jmv.25674
Xiao, 2020, Dynamic profile of RT-PCR findings from 301 COVID-19 patients in Wuhan, China: A descriptive study, J. Clin. Virol., 127, 104346, 10.1016/j.jcv.2020.104346
Yan, 2020, Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay, Clin. Microbiol. Infect., 26, 773, 10.1016/j.cmi.2020.04.001
Imai, 2020, Clinical evaluation of self-collected saliva by RT-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19, J. Clin. Microbiol., 164, 112316
Huang, 2020, Ultra-sensitive and high-throughput CRISPR-p owered COVID-19 diagnosis, Biosens. Bioelectron., 164, 112316, 10.1016/j.bios.2020.112316
Aguiar, 2020, The COVID-19 Diagnostic Technology Landscape: Efficient Data Sharing Drives Diagnostic Development, Front. Public Health, 8, 309, 10.3389/fpubh.2020.00309
Wang, 2020, Detection of SARS-CoV-2 in Different Types of Clinical Specimens, JAMA J. Am. Med. Assoc., 323, 1843
Hentzien, 2020, Should RT-PCR be considered a gold standard in the diagnosis of Covid-19?, J. Med. Virol., 92, 2312, 10.1002/jmv.25996
Li, 2020, False-negative results of real-time reverse-transcriptase polymerase chain reaction for severe acute respiratory syndrome coronavirus 2: Role of deep-learning-based ct diagnosis and insights from two cases, Korean J. Radiol., 21, 505, 10.3348/kjr.2020.0146
Corman, 2020, Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR, Eurosurveillance, 25, 2000045, 10.2807/1560-7917.ES.2020.25.3.2000045
Simoska, 2019, Electrochemical sensors for rapid diagnosis of pathogens in real time, Analyst, 144, 6461, 10.1039/C9AN01747J
Singhal, 2020, A Review of Coronavirus Disease-2019 (COVID-19), Indian J. Pediatr., 87, 281, 10.1007/s12098-020-03263-6
Kubina, R., and Dziedzic, A. (2020). Molecular and Serological Tests for COVID-19. A Comparative Review of SARS-CoV-2 Coronavirus Laboratory and Point-of-Care Diagnostics. Diagnostics, 10.
Alizargar, 2020, Saliva samples as an alternative for novel coronavirus (COVID-19) diagnosis, J. Formos. Med. Assoc., 119, 1234, 10.1016/j.jfma.2020.04.030
Yu, 2020, Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients, Clin. Infect. Dis., 71, 793, 10.1093/cid/ciaa345
Tang, 2020, The Laboratory Diagnosis of COVID-19 Infection: Current Issues and Challenges, J. Clin. Microbiol., 58, e00512-20, 10.1128/JCM.00512-20
James, A.S., and Alwneh, J.I. (2020). COVID-19 infection diagnosis: Potential impact of isothermal amplification technology to reduce community transmission of SARS-CoV-2. Diagnostics, 10.
Chan, 2020, Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-PCR assay validated in vitro and with clinical specimens, J. Clin. Microbiol., 58, e00310-20, 10.1128/JCM.00310-20
Vogels, 2020, Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT–qPCR primer–probe sets, Nat. Microbiol., 5, 1299, 10.1038/s41564-020-0761-6
Yan, 2020, Laboratory testing of SARS-CoV, MERS-CoV, and SARS-CoV-2 (2019-nCoV): Current status, challenges, and countermeasures, Rev. Med. Virol., 30, e2106, 10.1002/rmv.2106
Lieberman, J.A., Pepper, G., Naccache, S.N., Huang, M.L., Jerome, K.R., and Greninger, A.L. (2020). Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories. J. Clin. Microbiol., 58.
Zhen, 2020, Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens, J. Clin. Microbiol., 58, e00743-20, 10.1128/JCM.00743-20
Liu, 2020, Positive rate of RT-PCR detection of SARS-CoV-2 infection in 4880 cases from one hospital in Wuhan, China, from Jan to Feb 2020, Clin. Chim. Acta, 505, 172, 10.1016/j.cca.2020.03.009
Chu, 2020, Molecular Diagnosis of a Novel Coronavirus (2019-nCoV) Causing an Outbreak of Pneumonia, Clin. Chem., 66, 549, 10.1093/clinchem/hvaa029
Fachi, 2020, Cobre, A.; Tonin, F.S.; Pontarolo, R. Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19, Am. J. Infect. Control, 49, 21
Mitchell, 2020, Understanding, verifying and implementing Emergency Use Authorization molecular diagnostics for the detection of SARS-CoV-2 RNA, J. Clin. Microbiol., 58, e00796-20, 10.1128/JCM.00796-20
Chau, 2020, COVID-19 Clinical Diagnostics and Testing Technology, Pharmacotherapy, 40, 857, 10.1002/phar.2439
Luo, Z., Jin Yan Ang, M., Yin Chan, S., Yi, Z., Yiing Goh, Y., Yan, S., Tao, J., Liu, K., Li, X., and Zhang, H. (2020). Combating the Coronavirus Pandemic: Early Detection, Medical Treatment, and a Concerted Effort by the Global Community. Research, 6925296.
Li, 2020, Laboratory Diagnosis of Coronavirus Disease-2019 (COVID-19), Clin. Chim. Acta, 510, 35, 10.1016/j.cca.2020.06.045
(2020, August 05). Cepheid Xpert® Xpress SARS-CoV-2. Available online: https://www.cepheid.com/coronavirus.
Alvin, 2020, How to perform a nasopharyngeal swab in adults and children in the COVID-19 era, Eur. Ann. Otorhinolaryngol. Head Neck Dis., 137, 325, 10.1016/j.anorl.2020.06.001
Wang, 2020, Nasopharyngeal Swabs Are More Sensitive Than Oropharyngeal Swabs for COVID-19 Diagnosis and Monitoring the SARS-CoV-2 Load, Front. Med., 7, 334, 10.3389/fmed.2020.00334
Lin, 2020, Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19), Clin. Chem. Lab. Med., 58, 1089, 10.1515/cclm-2020-0187
Kim, 2020, Viral load kinetics of SARS-CoV-2 infection in first two patients in Korea, J. Korean Med. Sci., 35, e86, 10.3346/jkms.2020.35.e86
Pan, 2020, Potential False-Negative Nucleic Acid Testing Results for Severe Acute Respiratory Syndrome Coronavirus 2 from Thermal Inactivation of Samples with Low Viral Loads, Clin. Chem., 66, 794, 10.1093/clinchem/hvaa091
Leung, 2020, Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study, Lancet Infect. Dis., 20, 565, 10.1016/S1473-3099(20)30196-1
Xie, 2020, Comparison of different samples for 2019 novel coronavirus detection by nucleic acid amplification tests, Int. J. Infect. Dis., 93, 264, 10.1016/j.ijid.2020.02.050
Ministry of Health (2020, October 02). NOTA TÉCNICA No 34/2020-CGLAB/DAEVS/SVS/MS, Available online: http://www.lacen.saude.pr.gov.br/sites/lacen/arquivos_restritos/files/documento/2020-09/nota_tecnica_34_0.pdf.
Rothe, 2020, Transmission of 2019-NCOV infection from an asymptomatic contact in Germany, N. Engl. J. Med., 382, 970, 10.1056/NEJMc2001468
Bai, 2020, Presumed Asymptomatic Carrier Transmission of COVID-19, JAMA J. Am. Med. Assoc., 323, 1406, 10.1001/jama.2020.2565
Zhang, Y., Wang, C., Han, M., Ye, J., Gao, Y., Liu, Z., He, T., Li, T., Xu, M., and Zhou, L. (2020). Discrimination of False Negative Results in RT-PCR Detection of SARS-CoV-2 RNAs in Clinical Specimens by Using an Internal Reference. Virol. Sin., 1–10.
Song, 2020, A COVID-19 patient with seven consecutive false-negative rRT-PCR results from sputum specimens, Intern. Emerg. Med., 15, 871, 10.1007/s11739-020-02423-y
Baron, 2020, Frequency of serological non-responders and false-negative RT-PCR results in SARS-CoV-2 testing: A population-based study, Clin. Chem. Lab. Med., 58, 2131, 10.1515/cclm-2020-0978
Tahamtan, 2020, Real-time RT-PCR in COVID-19 detection: Issues affecting the results, Expert Rev. Mol. Diagn., 20, 453, 10.1080/14737159.2020.1757437
Visseaux, 2020, Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection, J. Clin. Virol., 129, 104520, 10.1016/j.jcv.2020.104520
Yip, 2020, Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection, J. Clin. Virol., 129, 104476, 10.1016/j.jcv.2020.104476
Nalla, 2020, Comparative Performance of SARS-CoV-2 Detection Assays Using Seven Different Primer-Probe Sets and One Assay Kit, J. Clin. Microbiol., 58, e00557-20, 10.1128/JCM.00557-20
Szymczak, 2020, Utility of Stool PCR for the Diagnosis of COVID-19: Comparison of Two Commercial Platforms, J. Clin. Microbiol., 58, e01369-20, 10.1128/JCM.01369-20
Pujadas, 2020, Comparison of SARS-CoV-2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS-CoV-2 test and a laboratory-developed real-time RT-PCR test, J. Med. Virol., 92, 1695, 10.1002/jmv.25988
Craney, 2020, Comparison of Two High-Throughput Reverse Transcription-Polymerase Chain Reaction Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2, J. Clin. Microbiol., 58, e00890-20, 10.1128/JCM.00890-20
Perng, 2020, Novel rapid identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by real-time RT-PCR using BD Max Open System in Taiwan, PeerJ, 8, e9318, 10.7717/peerj.9318
Wijsman, 2020, Comparison of seven commercial RT-PCR diagnostic kits for COVID-19, J. Clin. Virol., 128, 104412, 10.1016/j.jcv.2020.104412
Leven, 2020, Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2, J. Clin. Virol., 129, 104510, 10.1016/j.jcv.2020.104510
Bordi, 2020, Rapid and sensitive detection of SARS-CoV-2 RNA using the SimplexaTM COVID-19 direct assay, J. Clin. Virol., 128, 104416, 10.1016/j.jcv.2020.104416
He, 2020, Diagnostic performance between CT and initial real-time RT-PCR for clinically suspected 2019 coronavirus disease (COVID-19) patients outside Wuhan, China, Respir. Med., 168, 105980, 10.1016/j.rmed.2020.105980
Fisher, 2020, The importance of repeat testing in detecting coronavirus disease 2019 (COVID-19) in a coronary artery bypass grafting patient, J. Card. Surg., 35, 1342, 10.1111/jocs.14604
Ooi, 2004, Severe acute respiratory syndrome: Temporal lung changes at thin-section CT in 30 patients, Radiology, 230, 836, 10.1148/radiol.2303030853
Ajlan, 2014, Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection: Chest CT Findings, Am. J. Roentgenol., 203, 782, 10.2214/AJR.14.13021
Li, 2020, Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management, Am. J. Roentgenol., 214, 1280, 10.2214/AJR.20.22954
Waller, 2020, The Limited Sensitivity of Chest Computed Tomography Relative to Reverse Transcription Polymerase Chain Reaction for Severe Acute Respiratory Syndrome Coronavirus-2 Infection A Systematic Review on COVID-19 Diagnostics, Invest. Radiol., 55, 1, 10.1097/RLI.0000000000000700
Notomi, 2000, Loop-mediated isothermal amplification of DNA, Nucleic Acids Res., 28, 63, 10.1093/nar/28.12.e63
Mori, 2020, Loop-mediated isothermal amplification (LAMP): Expansion of its practical application as a tool to achieve universal health coverage, J. Infect. Chemother., 26, 13, 10.1016/j.jiac.2019.07.020
Santiago, 2020, Trends and Innovations in Biosensors for COVID-19 Mass Testing, ChemBioChem, 21, 1, 10.1002/cbic.202000250
Zhang, 2019, LAMP-on-a-chip: Revising microfluidic platforms for loop-mediated DNA amplification, TrAC Trends Anal. Chem., 113, 44, 10.1016/j.trac.2019.01.015
Ahn, S.J., Baek, Y.H., Lloren, K.K.S., Choi, W.-S., Jeong, J.H., Antigua, K.J.C., Kwon, H., Park, S.-J., Kim, E.-H., and Kim, Y. (2019). Rapid and simple colorimetric detection of multiple influenza viruses infecting humans using a reverse transcriptional loop-mediated isothermal amplification (RT-LAMP) diagnostic platform. BMC Infect. Dis., 19.
Paiva, 2019, Development and Validation of Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) for Rapid Detection of ZIKV in Mosquito Samples from Brazil, Sci. Rep., 9, 1
Lee, 2017, One-pot reverse transcriptional loop-mediated isothermal amplification (RT-LAMP) for detecting MERS-CoV, Front. Microbiol., 7, 2166, 10.3389/fmicb.2016.02166
Poon, 2004, Rapid detection of the Severe Acute Respiratory Syndrome (SARS) coronavirus by a loop-mediated isothermal amplification assay, Clin. Chem., 50, 1050, 10.1373/clinchem.2004.032011
Vashist, S.K. (2020). In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends. Diagnostics, 10.
Harrington, 2020, Comparison of abbott id now and abbott m2000 methods for the detection of sars-cov-2 from nasopharyngeal and nasal swabs from symptomatic patients, J. Clin. Microbiol., 58, 798, 10.1128/JCM.00798-20
Um, 2020, Development of a reverse transcription-loop-mediated isothermal amplification as a rapid early-detection method for novel SARS-CoV-2, Emerg. Microbes Infect., 9, 998, 10.1080/22221751.2020.1756698
Lu, R., Wu, X., Wan, Z., Li, Y., Jin, X., and Zhang, C. (2020). A novel reverse transcription loop-mediated isothermal amplification method for rapid detection of SARS-CoV-2. Int. J. Mol. Sci., 21.
Jiang, 2020, Development and Validation of a Rapid, Single-Step Reverse Transcriptase Loop-Mediated Isothermal Amplification (RT-LAMP) System Potentially to Be Used for Reliable and High-Throughput Screening of COVID-19, Front. Cell. Infect. Microbiol., 10, 331, 10.3389/fcimb.2020.00331
Huang, 2020, RT-LAMP for rapid diagnosis of coronavirus SARS-CoV-2, Microb. Biotechnol., 13, 950, 10.1111/1751-7915.13586
Lin, 2020, Rapid detection of COVID-19 coronavirus using a reverse transcriptional loop-mediated isothermal amplification (RT-LAMP) diagnostic platform, Clin. Chem., 66, 975, 10.1093/clinchem/hvaa102
Kitagawa, 2020, Evaluation of rapid diagnosis of novel coronavirus disease (COVID-19) using loop-mediated isothermal amplification, J. Clin. Virol., 129, 104446, 10.1016/j.jcv.2020.104446
James, P., Stoddart, D., Harrington, E.D., Beaulaurier, J., Ly, L., Reid, S.W., Turner, D.J., and Juul, S. (2020). LamPORE: Rapid, accurate and highly scalable molecular screening for SARS-CoV-2 infection, based on nanopore sequencing. medRxiv.
Obande, 2020, Current and Future Perspectives on Isothermal Nucleic Acid Amplification Technologies for Diagnosing Infections, Infect. Drug Resist., 13, 455, 10.2147/IDR.S217571
Feng, 2020, Molecular diagnosis of COVID-19: Challenges and research needs, Anal. Chem., 92, 10196, 10.1021/acs.analchem.0c02060
McCarthy, 2020, Harnessing the potential of CRISPR-based platforms to advance the field of hospital medicine, Expert Rev. Anti. Infect. Ther., 18, 799, 10.1080/14787210.2020.1761333
Esbin, 2020, Overcoming the bottleneck to widespread testing: A rapid review of nucleic acid testing approaches for COVID-19 detection, RNA, 26, 771, 10.1261/rna.076232.120
Nestor, 2020, Beyond Mendelian Genetics: Anticipatory Biomedical Ethics and Policy Implications for the Use of CRISPR Together with Gene Drive in Humans, J. Bioethical Inq., 17, 133, 10.1007/s11673-019-09957-7
Joung, 2020, Detection of SARS-CoV-2 with SHERLOCK One-Pot Testing, N. Engl. J. Med., 383, 1492, 10.1056/NEJMc2026172
FDA (2020, July 19). Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020, Available online: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-7-2020.
Sheridan, 2020, COVID-19 spurs wave of innovative diagnostics, Nat. Biotechnol., 38, 769, 10.1038/s41587-020-0597-x
Zhang, F., Abudayyeh, O.O., and Gootenberg, J.S. A Protocol for Detection of Covid-19 Using Crispr Diagnostics. (updated).
Broughton, 2020, CRISPR–Cas12-based detection of SARS-CoV-2, Nat. Biotechnol., 38, 870, 10.1038/s41587-020-0513-4
Morgeson, 2020, Recent Biotechnological Tools for Diagnosis of COVID-19 Disease: A review, Biotechnol. Prog., 9, e3078
(2020, October 01). Respiratory Virus Infections Working Group Canadian Public Health Laboratory Network Best Practices for COVID-19. Available online: https://nccid.ca/wp-content/uploads/sites/2/2020/05/COVID-Best-Practices-V1.01-v3.pdf.
Dias, 2020, Vidal, C.F.; Ben Corradi, M.F.D.; Michelin, L.; Muglia, V.; Rocha, J.L.L.; Costa, S.F.; de Oliveira, P.R.D.; Carrilho, C.M.; et al. Orientações sobre Diagnóstico, Tratamento e Isolamento de Pacientes com COVID-19, J. Infect. Control, 9, 56
Ferreira, L., Mota, P., Ferreira, P., Freitas, S., Campainha, S., Clemente, S., and Areias, V. (2020, October 01). Recomendações da spp no Diagnóstico e Tratamento de Doenças Difusas do Pulmão Durante a Pandemia por Sars-Cov-2. Available online: https://www.sppneumologia.pt/uploads/subcanais_conteudos_ficheiros/recomendacoes-da-spp-no-diagnostico-e-no-tratamento-de-doencas-difusas-do-pulmao-durante-a-pandemia-por-sars-cov-2.pdf.
China National Health Commission (2020, October 01). Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th Edition). Available online: http://kjfy.meetingchina.org/msite/news/show/cn/3337.html.
Davarpanah, 2020, Novel Screening and Triage Strategy in Iran During Deadly Coronavirus Disease 2019 (COVID-19) Epidemic: Value of Humanitarian Teleconsultation Service, J. Am. Coll. Radiol., 17, 734, 10.1016/j.jacr.2020.03.015
Abedini, 2019, Diffusion of advanced medical imaging technology, CT, and MRI scanners, in Iran: A qualitative study of determinants, Int. J. Health Plann. Manag., 34, e397, 10.1002/hpm.2657
Fields, 2020, Coronavirus Disease 2019 (COVID-19) diagnostic technologies: A countrybased retrospective analysis of screening and containment procedures during the first wave of the pandemic, Clin. Imaging, 67, 2019, 10.1016/j.clinimag.2020.08.014
Ramdas, 2020, ‘Test, re-test, re-test’: Using inaccurate tests to greatly increase the accuracy of COVID-19 testing, Nat. Med., 26, 810, 10.1038/s41591-020-0891-7
Neilan, A.M., Losina, E., Bangs, A.C., Flanagan, C., Panella, C., Eskibozkurt, G.E., Mohareb, A., Hyle, E.P., Scott, J.A., and Weinstein, M.C. (2020). Clinical Impact, Costs, and Cost-Effectiveness of Expanded SARS-CoV-2 Testing in Massachusetts. Clin. Infect. Dis.
Gopalkrishnan, 2020, Pooling Samples to Increase SARS-CoV-2 Testing, J. Indian Inst. Sci., 100, 787, 10.1007/s41745-020-00204-2
Chen, 2020, A comparison of methods accounting for batch effects in differential expression analysis of UMI count based single cell RNA sequencing, Comput. Struct. Biotechnol. J., 18, 861, 10.1016/j.csbj.2020.03.026
Lagopati, 2020, Sample pooling strategies for SARS-CoV-2 detection, J. Virol. Methods, 289, 114044, 10.1016/j.jviromet.2020.114044
Mutesa, L., Ndishimye, P., Butera, Y., Souopgui, J., Uwineza, A., Rutayisire, R., Ndoricimpaye, E.L., Musoni, E., Rujeni, N., and Nyatanyi, T. (2020). A pooled testing strategy for identifying SARS-CoV-2 at low prevalence. Nature.
Reta, 2020, Molecular and Immunological Diagnostic Techniques of Medical Viruses, Int. J. Microbiol., 2020, 1, 10.1155/2020/8832728
Winter, 2020, The important role of serology for COVID-19 control, Lancet Infect. Dis., 20, 758, 10.1016/S1473-3099(20)30322-4
Rogers, 2020, The COVID-19 Diagnostic Dilemma: A Clinician’s Perspective, J. Clin. Microbiol., 58, e01287-20, 10.1128/JCM.01287-20
Azkur, 2020, Immune response to SARS-CoV-2 and mechanisms of immunopathological changes in COVID-19, Allergy, 75, 1564, 10.1111/all.14364
Yu, 2020, Distinct features of SARS-CoV-2-specific IgA response in COVID-19 patients, Eur. Respir. J., 56, 2001526, 10.1183/13993003.01526-2020
Ghaffari, A., Meurant, R., and Ardakani, A. (2020). COVID-19 Serological Tests: How well do they actually perform?. Diagnostics, 10.
Capuzzo, 2020, Testing for SARS-CoV-2 (COVID-19): A systematic review and clinical guide to molecular and serological in-vitro diagnostic assays, Reprod. Biomed. Online, 41, 483, 10.1016/j.rbmo.2020.06.001
Lu, 2020, An evolving approach to the laboratory assessment of COVID-19, J. Med. Virol., 92, 1812, 10.1002/jmv.25954
Xiang, J., Yan, M., Li, H., Liu, T., Lin, C., Huang, S., and Shen, C. (2020). Evaluation of Enzyme-Linked Immunoassay and Colloidal Gold-Immunochromatographic Assay Kit for Detection of Novel Coronavirus (SARS-Cov-2) Causing an Outbreak of Pneumonia (COVID-19). medRxiv.
Guo, 2020, Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19), Clin. Infect. Dis., 71, 778, 10.1093/cid/ciaa310
Liu, 2020, Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2, J. Clin. Microbiol., 58, e00461-20, 10.1128/JCM.00461-20
Zhong, 2020, Detection of serum IgM and IgG for COVID-19 diagnosis, Sci. China Life Sci., 63, 777, 10.1007/s11427-020-1688-9
Sun, 2004, Antigenic Cross-Reactivity between the Nucleocapsid Protein of Severe Acute Respiratory Syndrome (SARS) Coronavirus and Polyclonal Antisera of Antigenic Group I Animal Coronaviruses: Implication for SARS Diagnosis, J. Clin. Microbiol., 42, 2351, 10.1128/JCM.42.5.2351-2352.2004
Mazzini, L., Martinuzzi, D., Hyseni, I., Benincasa, L., Molesti, E., Casa, E., Lapini, G., Piu, P., Trombetta, C.M., and Marchi, S. (2020). Comparative analyses of SARS-CoV-2 binding (IgG, IgM, IgA) and neutralizing antibodies from human serum samples. J. Immunol. Methods, 112937.
Scholz, 2020, Comparison of potency assays to assess SARS-CoV-2 neutralizing antibody capacity in COVID-19 convalescent plasma, J. Virol. Methods, 288, 114031
Wang, 2020, A human monoclonal antibody blocking SARS-CoV-2 infection, Nat. Commun., 11, 1
Abduljalil, 2020, Laboratory diagnosis of SARS-CoV-2: Available approaches and limitations, New Microbes New Infect., 36, 100713, 10.1016/j.nmni.2020.100713
Wang, 2020, Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures, J. Med. Virol., 92, 568, 10.1002/jmv.25748
Brochot, 2020, Comparison of different serological assays for SARS-CoV-2 in real life, J. Clin. Virol., 130, 104569, 10.1016/j.jcv.2020.104569
Kohmer, 2020, Clinical performance of different SARS-CoV-2 IgG antibody tests, J. Med. Virol., 92, 2243, 10.1002/jmv.26145
Tuaillon, 2020, Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients, J. Infect., 81, e39, 10.1016/j.jinf.2020.05.077
Lassaunière, R., Frische, A., Harboe, Z.B., Nielsen, A.C.Y., Fomsgaard, A., Krogfelt, K.A., and Jørgensen, C.S. (2020). Evaluation of nine commercial SARS-CoV-2 immunoassays. medRxiv.
GeurtsvanKessel, 2020, An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment, Nat. Commun., 11, 3436, 10.1038/s41467-020-17317-y
Mannonen, 2020, Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples, Eurosurveillance, 25, 2000603
Cinquanta, 2017, Chemiluminescent immunoassay technology: What does it change in autoantibody detection?, Autoimmun. Highlights, 8, 9, 10.1007/s13317-017-0097-2
Rostami, 2018, Advances in serological, imaging techniques and molecular diagnosis of Toxoplasma gondii infection, Infection, 46, 303, 10.1007/s15010-017-1111-3
Padoan, 2020, Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics, Clin. Chem. Lab. Med., 58, 1081, 10.1515/cclm-2020-0443
Jin, 2020, Diagnostic value and dynamic variance of serum antibody in coronavirus disease 2019, Int. J. Infect. Dis., 94, 49, 10.1016/j.ijid.2020.03.065
Hu, Q., Cui, X., Liu, X., Peng, B., Jiang, J., Wang, X., Li, Y., Hu, W., Ao, Z., and Duan, J. (2020). The production of antibodies for SARS-CoV-2 and its clinical implication. medRxiv.
Cai, 2020, A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Coronavirus Disease 2019 (COVID-19), J. Infect. Dis., 222, 189, 10.1093/infdis/jiaa243
Ma, H., Zeng, W., He, H., Zhao, D., Yang, Y., Jiang, D., Qi, Y., He, W., Zhao, C., and Yi, R. (2020). COVID-19 diagnosis and study of serum SARS-CoV-2 specific IgA, IgM and IgG by chemiluminescence immunoanalysis. medRxiv.
Wan, Y., Li, Z., Wang, K., Li, T., and Liao, P. (2020). Performance verification of detecting COVID-19 specific antibody by using four chemiluminescence immunoassay systems. medRxiv.
Montesinos, 2020, Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies, J. Clin. Virol., 128, 104413, 10.1016/j.jcv.2020.104413
Liu, R., Liu, X., Han, H., Adnan Shereen, M., Niu, Z., Liu, F., Wu, K., Luo, Z., and Zhu, C. (2020). The comparative superiority of IgM-IgG antibody test to real-time reverse 1 transcriptase PCR detection for SARS-CoV-2 infection diagnosis. medRxiv.
Kim, 2019, A new point-of-care test for the diagnosis of infectious diseases based on multiplex lateral flow immunoassays, Analyst, 144, 2460, 10.1039/C8AN02295J
Gomes, E.A., Costa, C.E., Junior-Delduque, J., Maia, J.N.B., and Pinto, P.B.O.P. (2020, October 01). Brazil’s Policy Responses to COVID-19, Available online: https://www.gov.br/economia/pt-br/centrais-de-conteudo/publicacoes/publicacoes-em-outros-idiomas/covid-19/brazil2019s-policy-responses-to-covid-19.
Laureano, 2020, The different tests for the diagnosis of covid-19-a review in Brazil so far, J. Bras. Reprod. Assist., 24, 340
Ravi, 2020, Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape, Biosens. Bioelectron., 165, 112454, 10.1016/j.bios.2020.112454
Peel, M., Khan, M., Dombey, D., and Pitel, L. (2020, September 11). Countries Reject China Pandemic Product Batches. Available online: https://www.ft.com/content/f3435779-a706-45c7-a7e2-43efbdd7777b.
Baker, S. (2020, September 11). Coronavirus: Spain Returning 2nd Batch of Faulty Tests to Bioeasy China. Available online: https://www.businessinsider.com/coronavirus-spain-returns-second-batch-faulty-tests-bioeasy-china-2020-4.
Chakraborty, B. (2020, September 11). Netherlands Becomes Latest Country to Reject China-Made Coronavirus Test Kits. Available online: https://www.foxnews.com/world/netherlands-becomes-latest-country-to-reject-china-made-coronavirus-test-kits-gear.
Adams, 2020, Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel, Wellcome Open Res., 5, 139, 10.12688/wellcomeopenres.15927.1
Boesecke, 2020, Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity, Public Health, 182, 170, 10.1016/j.puhe.2020.04.009
Shamsollahi, H.R., Amini, M., Alizadeh, S., Nedjat, S., Akbari-Sari, A., Rezaei, M., Farshad Allameh, S., Fotouhi, A., and Yunesian, M. (2020). Assessment of a serological diagnostic kit of SARS-CoV-2 availble in Iran. medRxiv.
Whitman, J.D., Hiatt, J., Mowery, C.T., Shy, B.R., Yu, R., Yamamoto, T.N., Rathore, U., Goldgof, G.M., Whitty, C., and Woo, J.M. (2020). Test performance evaluation of SARS-CoV-2 serological assays. medRxiv.
Imai, 2020, Clinical evaluation of an immunochromatographic IgM/IgG antibody assay and chest computed tomography for the diagnosis of COVID-19, J. Clin. Virol., 128, 104393, 10.1016/j.jcv.2020.104393
Shen, 2020, Delayed specific IgM antibody responses observed among COVID-19 patients with severe progression, Emerg. Microbes Infect., 9, 1096, 10.1080/22221751.2020.1766382
Andryukov, 2020, Six decades of lateral flow immunoassay: From determining metabolic markers to diagnosing COVID-19, AIMS Microbiol., 6, 280, 10.3934/microbiol.2020018
Cassaniti, 2020, Performance of VivaDiag COVID—19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID—19 in acute patients referring to emergency room department, J. Med. Virol., 92, 1724, 10.1002/jmv.25800
Pan, 2020, Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients, J. Infect., 81, 28, 10.1016/j.jinf.2020.03.051
Shen, 2020, Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG, Am. J. Transl. Res., 12, 1348
Pérez-García, F., Pérez-Tanoira, R., Romanyk, J., Arroyo, T., Gómez-Herruz, P., and Cuadros-González, J. (2020). Rapid diagnosis of SARS-CoV-2 infection by detecting IgG and IgM antibodies 3 with an immunochromatographic device: A prospective single-center study Running title: Rapid serologic test to diagnose SARS-CoV-2 infection. medRxiv.
Spicuzza, 2020, Reliability and usefulness of a rapid IgM-IgG antibody test for the diagnosis of SARS-CoV-2 infection: A preliminary report, J. Infect., 81, e53, 10.1016/j.jinf.2020.04.022
Virgilioparadiso, A., De Summa, S., Loconsole, D., Procacci, V., Sallustio, A., Centrone, F., Silvestris, N., Cafagna, V., De Palma, G., and Tufaro, A. (2020). Clinical meanings of rapid serological assay in patients tested for SARS-Co2 RT-PCR. medRxiv.
Demey, 2020, Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays, J. Infect., 81, e6, 10.1016/j.jinf.2020.04.033
Serrano, 2020, Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection, J. Clin. Virol., 129, 104529, 10.1016/j.jcv.2020.104529
Mlcochova, 2020, Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant, Cell Rep. Med., 1, 100099, 10.1016/j.xcrm.2020.100099
Augustine, R., Das, S., Hasan, A., Abhilash, S., Abdul Salam, S., Augustine, P., Dalvi, Y.B., Varghese, R., Primavera, R., and Yassine, H.M. (2020). Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World. J. Clin. Med., 9.
CDC (2020, December 17). Interim Guidance for Antigen Testing for SARS-CoV-2, Available online: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html.
Li, D., and Li, J. (2020). Immunologic testing for SARS-CoV-2 infection from the antigen perspective. J. Clin. Microbiol.
Yang, X., and Sun, X. (2005). Chemiluminescent immunometric detection of sars-cov in sera as an early marker for the diagnosis of sars. Biolumin. Chemilumin., 491–494.
Che, 2004, Sensitive and specific monoclonal antibody-based capture enzyme immunoassay for detection of nucleocapsid antigen in sera from patients with severe acute respiratory syndrome, J. Clin. Microbiol., 42, 2629, 10.1128/JCM.42.6.2629-2635.2004
(2020, December 17). Abbott BinaxNOWTM COVID-19 Ag CARD. Available online: www.globalpointofcare.abbott.
Perchetti, G., Huang, M., Mills, M., Jerome, K., and Greninger, A. (2020). Analytical Sensitivity of the Abbott BinaxNOW COVID-19 Ag CARD. J. Clin. Microbiol.
Mak, 2020, Evaluation of rapid antigen test for detection of SARS-CoV-2 virus, J. Clin. Virol., 129, 104500, 10.1016/j.jcv.2020.104500
Cornelissen, 2020, Comparison of the SARS-CoV-2 Rapid Antigen Test to the Real Star Sars-CoV-2 RT PCR Kit, J. Virol. Methods, 288, 114024
Blairon, 2020, Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital, J. Clin. Virol., 129, 104472, 10.1016/j.jcv.2020.104472
Muruato, 2020, A high-throughput neutralizing antibody assay for COVID-19 diagnosis and vaccine evaluation, Nat. Commun., 11, 1, 10.1038/s41467-020-17892-0
(2020, September 14). CDC Interim Guidelines for COVID-19 Antibody Testing, Available online: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html.
Li, 2020, Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected Pneumonia, N. Engl. J. Med., 382, 1199, 10.1056/NEJMoa2001316
He, 2020, Temporal dynamics in viral shedding and transmissibility of COVID-19, Nat. Med., 26, 672, 10.1038/s41591-020-0869-5
Sethuraman, 2020, Interpreting Diagnostic Tests for SARS-CoV-2, JAMA J. Am. Med. Assoc., 323, 2249, 10.1001/jama.2020.8259
Weiss, 2020, Clinical course and mortality risk of severe COVID-19, Lancet, 395, 1014, 10.1016/S0140-6736(20)30633-4
Zheng, 2020, Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: Retrospective cohort study, BMJ, 369, m1443, 10.1136/bmj.m1443
Kawase, 2018, Rapid and Accurate Diagnosis Based on Real-Time PCR Cycle Threshold Value for the Identification of Campylobacter jejuni, astA Gene-Positive Escherichia coli, and eae Gene-Positive E. coli, Jpn. J. Infect. Dis., 71, 79, 10.7883/yoken.JJID.2017.151
Chang, 2020, Interpreting the COVID-19 Test Results: A Guide for Physiatrists, Am. J. Phys. Med. Rehabil., 99, 583, 10.1097/PHM.0000000000001471
Jang, 2020, Viral kinetics of SARS-CoV-2 over the preclinical, clinical, and postclinical period, Int. J. Infect. Dis., 102, 561, 10.1016/j.ijid.2020.10.099
Louie, J.K., Stoltey, J., Scott, H.M., Trammell, S., Ememu, E., Samuel, M.C., Aragon, T., and Masinde, G. (2020). Comparison of Symptomatic and Asymptomatic Infections due to COVID-19 in San Francisco Long Term Care Facilities. Infect. Control Hosp. Epidemiol., 1–8.
Singanayagam, 2020, Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020, Eurosurveillance, 25, 2001483, 10.2807/1560-7917.ES.2020.25.32.2001483
Gorzalski, 2020, Characteristics of viral specimens collected from asymptomatic and fatal cases of COVID-19, J. Biomed. Res., 34, 431, 10.7555/JBR.34.20200110
Corman, 2020, Virological assessment of hospitalized patients with COVID-2019, Nature, 581, 465, 10.1038/s41586-020-2196-x
Lou, 2020, Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset, Eur. Respir. J., 56, 2000763, 10.1183/13993003.00763-2020
Xiao, 2020, Profile of specific antibodies to SARS-CoV-2: The first report, J. Infect., 81, 147, 10.1016/j.jinf.2020.03.012
Hamilton, 2020, Kinetics and performance of the Abbott architect SARS-CoV-2 IgG antibody assay, J. Infect., 81, e7, 10.1016/j.jinf.2020.07.031
Suhandynata, 2020, Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19, J. Appl. Lab. Med., 5, 908, 10.1093/jalm/jfaa079
Wang, 2020, Meta-analysis of diagnostic performance of serology tests for COVID-19: Impact of assay design and post-symptom-onset intervals, Emerg. Microbes Infect., 9, 2200, 10.1080/22221751.2020.1826362
Ren, 2020, The kinetics of humoral response and its relationship with the disease severity in COVID-19, Commun. Biol., 3, 780, 10.1038/s42003-020-01526-8
Li, 2020, Molecular and serological characterization of SARS-CoV-2 infection among COVID-19 patients, Virology, 551, 26, 10.1016/j.virol.2020.09.008
Brochot, 2020, Anti-spike, Anti-nucleocapsid and Neutralizing Antibodies in SARS-CoV-2 Inpatients and Asymptomatic Individuals, Front. Microbiol., 11, 2468, 10.3389/fmicb.2020.584251
Wajnberg, 2020, Robust neutralizing antibodies to SARS-CoV-2 infection persist for months, Science, 370, 1227, 10.1126/science.abd7728