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Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR).
BMC Infect Dis. 2020 Oct 20; 20(1):783.BI

Abstract

BACKGROUND

A cost effective and efficient diagnostic tool for COVID-19 as near to the point of care (PoC) as possible would be a game changer in the current pandemic. We tested reverse transcription loop mediated isothermal amplification (RT-LAMP), a method which can produce results in under 30 min, alongside standard methods in a real-life clinical setting.

METHODS

This prospective service improvement project piloted an RT-LAMP method on nasal and pharyngeal swabs on 21 residents of a high dependency care home, with two index COVID-19 cases, and compared it to multiplex tandem reverse transcription polymerase chain reaction (RT-PCR). We recorded vital signs of patients to correlate clinical and laboratory information and calculated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a single swab using RT-LAMP compared with the current standard, RT-PCR, as per Standards for Reporting Diagnostic Accuracy Studies (STARD) guidelines.

RESULTS

The novel method accurately detected 8/10 RT-PCR positive cases and identified a further 3 positive cases. Eight further cases were negative using both methods. Using repeated RT-PCR as a "gold standard", the sensitivity and specificity of a single novel test were 80 and 73% respectively. PPV was 73% and NPV was 83%. Incorporating retesting of low signal RT-LAMP positives improved the specificity to 100%. We also speculate that hypothermia may be a significant early clinical sign of COVID-19.

CONCLUSIONS

RT-LAMP testing for SARS-CoV-2 was found to be promising, fast and to work equivalently to RT-PCR methods. RT-LAMP has the potential to transform COVID-19 detection, bringing rapid and accurate testing to the PoC. RT-LAMP could be deployed in mobile community testing units, care homes and hospitals to detect disease early and prevent spread.

Authors+Show Affiliations

Department of Ageing & Health, Guy's and St Thomas' NHS Foundation Trust, London, UK.Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.Department of Ageing & Health, Guy's and St Thomas' NHS Foundation Trust, London, UK. Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.MicrosensDx Ltd, 2 Royal College Street, London, UK.Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.MicrosensDx Ltd, 2 Royal College Street, London, UK.Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.Department of Ageing & Health, Guy's and St Thomas' NHS Foundation Trust, London, UK. claire.j.steves@kcl.ac.uk. Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK. claire.j.steves@kcl.ac.uk.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

33081710

Citation

Österdahl, Marc F., et al. "Detecting SARS-CoV-2 at Point of Care: Preliminary Data Comparing Loop-mediated Isothermal Amplification (LAMP) to Polymerase Chain Reaction (PCR)." BMC Infectious Diseases, vol. 20, no. 1, 2020, p. 783.
Österdahl MF, Lee KA, Lochlainn MN, et al. Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR). BMC Infect Dis. 2020;20(1):783.
Österdahl, M. F., Lee, K. A., Lochlainn, M. N., Wilson, S., Douthwaite, S., Horsfall, R., Sheedy, A., Goldenberg, S. D., Stanley, C. J., Spector, T. D., & Steves, C. J. (2020). Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR). BMC Infectious Diseases, 20(1), 783. https://doi.org/10.1186/s12879-020-05484-8
Österdahl MF, et al. Detecting SARS-CoV-2 at Point of Care: Preliminary Data Comparing Loop-mediated Isothermal Amplification (LAMP) to Polymerase Chain Reaction (PCR). BMC Infect Dis. 2020 Oct 20;20(1):783. PubMed PMID: 33081710.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR). AU - Österdahl,Marc F, AU - Lee,Karla A, AU - Lochlainn,Mary Ni, AU - Wilson,Stuart, AU - Douthwaite,Sam, AU - Horsfall,Rachel, AU - Sheedy,Alyce, AU - Goldenberg,Simon D, AU - Stanley,Christopher J, AU - Spector,Tim D, AU - Steves,Claire J, Y1 - 2020/10/20/ PY - 2020/05/11/received PY - 2020/10/06/accepted PY - 2020/10/21/entrez PY - 2020/10/22/pubmed PY - 2020/10/28/medline SP - 783 EP - 783 JF - BMC infectious diseases JO - BMC Infect Dis VL - 20 IS - 1 N2 - BACKGROUND: A cost effective and efficient diagnostic tool for COVID-19 as near to the point of care (PoC) as possible would be a game changer in the current pandemic. We tested reverse transcription loop mediated isothermal amplification (RT-LAMP), a method which can produce results in under 30 min, alongside standard methods in a real-life clinical setting. METHODS: This prospective service improvement project piloted an RT-LAMP method on nasal and pharyngeal swabs on 21 residents of a high dependency care home, with two index COVID-19 cases, and compared it to multiplex tandem reverse transcription polymerase chain reaction (RT-PCR). We recorded vital signs of patients to correlate clinical and laboratory information and calculated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a single swab using RT-LAMP compared with the current standard, RT-PCR, as per Standards for Reporting Diagnostic Accuracy Studies (STARD) guidelines. RESULTS: The novel method accurately detected 8/10 RT-PCR positive cases and identified a further 3 positive cases. Eight further cases were negative using both methods. Using repeated RT-PCR as a "gold standard", the sensitivity and specificity of a single novel test were 80 and 73% respectively. PPV was 73% and NPV was 83%. Incorporating retesting of low signal RT-LAMP positives improved the specificity to 100%. We also speculate that hypothermia may be a significant early clinical sign of COVID-19. CONCLUSIONS: RT-LAMP testing for SARS-CoV-2 was found to be promising, fast and to work equivalently to RT-PCR methods. RT-LAMP has the potential to transform COVID-19 detection, bringing rapid and accurate testing to the PoC. RT-LAMP could be deployed in mobile community testing units, care homes and hospitals to detect disease early and prevent spread. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/33081710/Detecting_SARS_CoV_2_at_point_of_care:_preliminary_data_comparing_loop_mediated_isothermal_amplification__LAMP__to_polymerase_chain_reaction__PCR__ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-05484-8 DB - PRIME DP - Unbound Medicine ER -