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28th February 2020  Editorial by: Paul Carton

LAMP-based Covid-19 Near-Patient Assay Provides Results in One Hour

During the current SARS-CoV-2 outbreak we've witnessed how a delay in results, whether its due to samples to be sent for testing or inefficient communication by health departments, has caused chaos in some circumstances and unfair stigmatism applied in other cases. The Dublin-based diagnostics company HiberGene who develop rapid LAMP-based infectious disease diagnostics for the Chinese market are now awaiting clinical evaluation in China on its LAMP-based Covid-19 assay, which can provide a patient with a result within an hour after taking their sample. 

In this interview, rapidmicrobiology.com talks to Gary Keating (Chief Technology Officer, HiberGene) on how near-patient testing can alleviate some of the problems during these worrying times.

Q: Why is near-patient testing a better choice in diagnosing for Covid-19?
A: While central reference laboratory testing for COVID-19 will likely remain an important element of the public health response to the spread of the virus, we believe there is also a clear need for near-patient testing to allow for rapid detection at the point of need, and speedy dissemination of results.

Q: What is the technology behind HiberGene's Covid-19 diagnostic assay?
A: Our COVID-19 test in development is based on the LAMP molecular technology used in HiberGene's panel of 10 on-market IVD tests.  The kits in our current product menu – which includes tests for bacterial meningitis, STIs and respiratory disease – consist of freeze-dried single-use amplification reagents supplied with sample treatment buffers, and all tests are run on our small, portable, battery-powered HG Swift analyser. Typical hands-on time for our tests, including sample preparation, is 5-10 minutes, and overall time to negative result is 50-70 minutes, with positive results generally available within 20-30 minutes.

Our COVID-19 assay reagents target a number of genes specific for the SARS-CoV-2 virus, including genes for both viral capsid and non-capsid proteins.

One key advantage of our technology is the ability of our reagents to function without highly purified patient samples.  For the COVID-19 test protocol, we've taken our Flu A/B test as the model: for this assay, nasopharyngeal swabs taken from the patient are diluted in our proprietary sample treatment buffer, treated sample is heated to release RNA from the viral particle, and the heated specimen is then added to freeze-dried reaction mix.

Q: Is it possible that your assay might become obsolete due to mutations in the virus?
A: Its too early to say with any certainty what the mutation rate of SARS-CoV-2, the causative agent of COVID-19, will be.  It seems possible that the mutation rate may turn out to be similar to that of the original SARS virus which emerged in 2002, in which case only slow, gradual change will likely be seen. This can be monitored by periodic review of databased sequences, and addressed – if required - by slightly modifying the assay reagents to take account of any observed variation in the relevant areas of the viral genome.

Q: What makes these viruses so lethal?
A: As this is a newly emerged human pathogen, there is no existing immunity.  But I think we'll need a lot more data before the impact of the virus is fully understood; for example, the role played by asymptomatic carriers in the spread of the disease is still far from clear.

Q: How do you feel the science community responded to this epidemic?
A: I feel that HiberGene's development of the new COVID-19 test has benefitted very strongly from the science community's timely and coordinated response to the outbreak.  The speed with which critical data has been generated and shared on open-access platforms, particularly with regard to access to viral gene sequences information, has been impressive.

Q: What is the future direction for HiberGene?
A: Having developed and launched 12 tests for a range of infectious diseases in our rapid manual assay format, we are now working on transitioning our proven amplification chemistry into a fully automated sample-to-result format.  Design and development work on the new analyser and cartridges is ongoing, as is the selection of assays for the initial launch.



Date Published: 28th February 2020

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