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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).
Österdahl, Marc F; Lee, Karla A; Lochlainn, Mary Ni; Wilson, Stuart; Douthwaite, Sam; Horsfall, Rachel; Sheedy, Alyce; Goldenberg, Simon D; Stanley, Christopher J; Spector, Tim D; Steves, Claire J.
  • Österdahl MF; Department of Ageing & Health, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Lee KA; Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.
  • Lochlainn MN; Department of Ageing & Health, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Wilson S; Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.
  • Douthwaite S; MicrosensDx Ltd, 2 Royal College Street, London, UK.
  • Horsfall R; Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Sheedy A; Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.
  • Goldenberg SD; Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.
  • Stanley CJ; Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Spector TD; MicrosensDx Ltd, 2 Royal College Street, London, UK.
  • Steves CJ; Department of Twin Research and Genetic Epidemiology, Kings College London, Westminster Bridge Road, London, SE1 7EH, UK.
BMC Infect Dis ; 20(1): 783, 2020 Oct 20.
Article in English | MEDLINE | ID: covidwho-883564
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Polymerase Chain Reaction / Coronavirus Infections / Point-of-Care Systems / Clinical Laboratory Techniques / Nucleic Acid Amplification Techniques / Molecular Diagnostic Techniques / Betacoronavirus / Preliminary Data Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2020 Document Type: Article Affiliation country: S12879-020-05484-8

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Polymerase Chain Reaction / Coronavirus Infections / Point-of-Care Systems / Clinical Laboratory Techniques / Nucleic Acid Amplification Techniques / Molecular Diagnostic Techniques / Betacoronavirus / Preliminary Data Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2020 Document Type: Article Affiliation country: S12879-020-05484-8