Comparing the Effectiveness of Colorimetric Reverse Transcription-Loop-Mediated Isothermal Amplification (SCoV-2 Detection Kit L1) with that of Reverse Transcription-Quantitative Polymerase Chain Reaction in SARS-CoV-2 Detection
Abstract
Objective: To determine the diagnostic sensitivity and specificity of reverse transcription-loop-mediated isothermal amplification (RT-LAMP) compared to those of reverse transcription-quantitative polymerase chain reaction (RT-qPCR) for coronavirus disease 2019 (COVID-19).
Material and Methods: A total of 382 nasopharyngeal swab samples obtained from 154 patients with COVID-19 were tested using RT-LAMP and RT-qPCR. The sensitivities and specificities of RT-LAMP were compared with those of RT-qPCR and analysed as a function of time from onset.
Results: Up to the third day after onset, the RT-LAMP SARS-CoV-2 positivity was 68.33%, and the sensitivity and specificity compared to those of RT-qPCR were 100.0%. However, on the third day after onset, the RT-LAMP SARS-CoV-2 positivity decreased to less than 50%. The limit of detection for the RT-LAMP assay was log10 SARS-CoV-2 RNA 2.2 copies/reaction. RT-LAMP had the same diagnostic accuracy as RT-qPCR until day 9 after symptom onset.
Conclusion: The findings suggest that RT-LAMP can be used as an alternative to RT-qPCR as a diagnostic tool for detecting COVID-19 during the acute symptomatic phase of COVID-19.
Keywords
Full Text:
PDFReferences
World Health Organization. Novel coronavirus nCoV. Situation Report [homepage on the Internet]. Geneva: WHO; 2019 [cited 2020 Mar 13]. Available from: https://www.who.int/docs/defaultsource/coronaviruse/situation-reports/20200131-sitrep-11-ncov.pdf?sfvrsn=de7c0f7_4
World Health Organization. Novel coronavirus nCoV [homepage on the Internet] Geneva: WHO; 2019 [cited 2020 Mar 13]. Available from: https://www.who.int/docs/defaultsource/coronaviruse/situation-reports/20200308-sitrep-48-covid-19.pdf?sfvrsn=16f7ccef_4
Cable News Network. The global coronavirus recession is beginning [homepage on the Internet] Atlanta: CNN; 2020 [cited 2020 Mar 13]. Available from: https://edition.cnn.com/2020/03/16/economy/global-recession-coronavirus/index.html
The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The epidemiological characteristics of an outbreak of 2019 novel coronavirus disease (COVID-19). China CDC Weekly 2020;2:113-22.
Munster VJ, Koopmans M, van Doremalen N, van Riel D, de Wit E. A novel coronavirus emerging in China—key questions for impact assessment. N Engl J Med 2020;382:692–4. doi: 10.1056/NEJMp2000929.
Hoehl S, Rabenau H, Berger A, Kortenbusch M, Cinatl J, Bojkova D, et al. Evidence of SARS-CoV-2 infection in returning travelers from Wuhan, China. N Engl J Med 2020;382:1278–80. doi: 10.1056/NEJMc2001899.
Gates B. Responding to Covid-19—A once-in-a-century pandemic? N Engl J Med 2020;382:1677–9. doi: 10.1056/NEJMp2003762.
Wang W, Tang J, Wei F. Updated understanding of the outbreak of 2019 novel coronavirus (2019-nCoV) in Wuhan, China. J Med Virol 2020;92:441–7. doi: 10.1002/jmv.25689.
Tang B, Bragazzi NL, Li Q, Tang S, Xiao Y, Wu J. An updated estimation of the risk of transmission of the novel coronavirus (2019-nCov). Infect Dis Modell 2020;5:248–55. doi: 10.1016/j.idm.2020.02.001.
Cyranoski D. Did pangolins spread the China coronavirus to people? Nature 2020. doi: 10.1038/d41586-020-00364-2.
Banerjee A, Kulcsar K, Misra V, Frieman M, Mossman K. Bats and coronaviruses. Viruses 2019;11:41. doi: 10.3390/v11010041.
World Health Organization. Recommendations to reduce risk of transmission of emerging pathogens from animals to humans in live animal markets [homepage on the Internt] Geneva: WHO; [Cited 2020 Mar 13]. Available from: https://www.who.int/health-topics/coronavirus/whorecommendations-to-reduce-risk-of-transmission-of-emerging-pathogens-from-animals-to-humansinlive-animal-markets
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:1708–20. doi: 10.1056/NEJMoa2002032.
Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, et al. Transmission of 2019-nCoV infection from an asymptomatic contact in Germany. N Engl J Med 2020;382:970–1. doi: 10.1056/NEJMc2001468.
Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, et al. A new coronavirus associated with human respiratory disease in China. Nature. 2020;579:265–9. doi: 10.1038/s41586-020-2008-3.
Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet 2020;395:689–97. doi: 10.1016/S0140-6736(20)30260-9.
Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DKW, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill 2020;25:2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045.
Nguyen T, Zoëga Andreasen S, Wolff A, Duong Bang D. From lab on a chip to point of care devices: the role of open source microcontrollers. Micromachines 2018;9:403. doi: 10.3390/mi9080403.
World Health Organization. Outbreak investigation [homepage on the Internet] Geneva: WHO; [Cited 2020 Mar 13]. Available from: https://www.who.int/hac/techguidance/training/outbreak%20investigation_en.pdf
Isere EE, Fatiregun AA, Ajayi IO. An overview of disease surveillance and notification system in Nigeria and the roles of clinicians in disease outbreak prevention and control. Niger Med J 2015;56:161–8. doi: 10.4103/0300-1652.160347.
Jones G, Le Hello S, Jourdan-da Silva NJ-D, Vaillant V, De Valk H, Weill F-X, et al. The French human Salmonella surveillance system: evaluation of timeliness of laboratory reporting and factors associated with delays, 2007 to 2011. Euro Surveill 2014;19:20664. doi: 10.2807/1560-7917.es2014.19.1.20664.
Sansure Biotech. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) [monograph on the Internet]. Changsha: Sansure Biotech Inc.; 2021 [cited 2020 Mar 13]. Available from: https://www.sansureglobal.com/wp-content/uploads/2022/12/EUA-IFU-Sansure-2019-nCoV-S3104E-V02.pdf
Jiang M, Pan W, Arasthfer A, Fang W, Ling L, Fang H, et al. 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 2020;10:331. doi: 10.3389/fcimb.2020.00331.
Chow FW-N, Chan TT-Y, Tam AR, Zhao S, Yao W, Fung J, et al. A rapid, simple, inexpensive, and mobile colorimetric assay COVID-19-LAMP for mass on-site screening of COVID-19. Int J Mol Sci 2020;21:5380. doi: 10.3390/ijms21155380.
Inaba M, Higashimoto Y, Toyama Y, Horiguchi T, Hibino M, Iwata M, et al. Diagnostic accuracy of LAMP versus PCR over the course of SARS-CoV-2 infection. Int J Infect Dis 2021;107:195–200. doi: 10.1016/j.ijid.2021.04.018.
Mallett S, Allen AJ, Graziadio S, Taylor SA, Sakai NS, Green K, et al. At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR-based tests? A systematic review of individual participant data. BMC Med 2020;18:346. doi: 10.1186/s12916-020-01810-8.
Park GS, Ku K, Baek SH, Kim SJ, Kim SI, Kim BT, et al. Development of reverse transcription loop-mediated isothermal amplification assays targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). J Mol Diagn 2020;22:729–35. doi: 10.1016/j.jmoldx.2020.03.006.
Refbacks
- There are currently no refbacks.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.