LoCKamp
Research type
Research Study
Full title
A study to evaluate the performance of a Lab-on-Chip LAMP device for rapid SARS-CoV-2 diagnosis
IRAS ID
310212
Contact name
Despina Moschou
Contact email
Sponsor organisation
University of Bath
ISRCTN Number
ISRCTN58218165
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Research Summary
PCR (polymerase chain reaction) tests are the “gold standard” test used for diagnosing SARS-CoV-2 (COVID-19). It's a test to detect genetic material from a specific organism, such as a virus. The current wait time for a PCR test, which requires that samples are sent to a lab, is anything up to 24 hours.
A team of clinicians, scientists and engineers from the Royal United Hospital in Bath and the University of Bath are developing a diagnostic testing system (called LoCKAmp) designed to give accurate PCR diagnosis of SARS-CoV-2 within 10 minutes of analysis, at clinical standard accuracy but without requiring a lab.
Using miniaturized microchips (microPCR) on a surface the size of a credit card, the test requires only a few droplets (μL-scale samples). The system has been proven functional and accurate in lab tests, is low-cost to produce and incorporates a portable, handheld device, which carries a disposable microchip performing the core biochemical analysis. The test result is displayed on an accompanying mobile app within 10 minutes of the patient swab insertion.
The aim is to carry out a pilot study by recruiting 100 patients over 3 months and asking them to donate an extra swab when they attend the RUH for a routine PCR test. This extra swab will be tested in the LoCKAmp system in a research laboratory, and the results compared to those obtained from the current “gold standard” PCR test. The patient care pathway will not be influenced by the results obtained from the LoCKAmp test.
Summary of Results
The recent COVID-19 outbreak highlighted the need for Lab-on-Chip diagnostic technology fit for real-life deployment in the field. Existing bottlenecks in multistep analytical microsystem integration and upscalable, standardized fabrication techniques delayed the large-scale deployment of Lab-on-Chip solutions during the outbreak, throughout a global diagnostic test shortage. This study presents a technology that has the potential to address these issues by redeploying and repurposing the ubiquitous Printed Circuit Board (PCB) technology and manufacturing infrastructure. We demonstrate the first commercially manufactured, miniaturised Lab-on-PCB device for loop-mediated isothermal amplification (LAMP) genetic detection of SARS-CoV-2. The system incorporates a mass-manufactured, continuous-flow PCB chip with ultra-low cost fluorescent detection circuitry, rendering it the only continuous-flow μLAMP platform with off-the-shelf optical detection components. Ultrafast, SARS-CoV-2 RNA amplification in wastewater samples was demonstrated within 2 min analysis, at concentrations as low as 17 gc/μL. We further demonstrate our device operation by detecting SARS-CoV-2 in 20 human nasopharyngeal swab samples, without the need for any RNA extraction or purification. This renders the presented miniaturised nucleic-acid amplification-based diagnostic test the fastest reported SARS-CoV-2 genetic detection platform, in a practical implementation suitable for deployment in the field. This technology can be readily extended to the detection of alternative pathogens or genetic targets for a very broad range of applications and matrices. LoCKAmp Lab-on-PCB chips are currently mass-manufactured in a commercial, ISO-compliant PCB factory, at a small-scale production cost of £2.50 per chip. Thus, with this work, we demonstrate a high technology‑readiness‑level Lab-on-Chip-based genetic detection system, successfully benchmarked against standard analytical techniques both for wastewater and nasopharyngeal swab SARS-CoV-2 detection.
REC name
West of Scotland REC 3
REC reference
22/WS/0038
Date of REC Opinion
29 Mar 2022
REC opinion
Favourable Opinion