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Trial Testing Point-of-Care Covid-19 Diagnostic

Research team leader Joanne Martin holds the Primer Design Q16 PCR device. (Queen Mary University of London)

23 July 2020. A clinical trial in the U.K. is assessing a testing device to detect Covid-19 viruses in nasal swab samples that returns results in an hour. The study evaluating portable diagnostic systems made by Primer Design, in Camberley, U.K., a company in the Novacyte Group, is conducted by researchers at Queen Mary University in London.

Controlling the Covid-19 pandemic requires easy, widespread access to diagnostic testing, to detect the spread of the disease in institutions and communities. The so-called gold standard diagnostic for the SARS-CoV-2 virus responsible for Covid-19 infections is the polymerase chain reaction or PCR test using samples from nasal swabs from the back of the throat, taken by a trained clinician. PCR is a common genetic analytical method that amplifies tiny quantities of genetic material for sequencing, in this case the characteristic viral RNA left by SARS-CoV-2 viruses.

The clinical trial is evaluating the Genesig Q16 portable diagnostic device made by Primer Design, using the company’s RNA extraction kits for SARS-CoV-2 viruses. The Genesig Q16 is a PCR-based genetic material detection system for a wide range of infectious diseases, biodefense applications, veterinary medicine, and food and water testing. For Covid-19 testing, Primer Design’s kit plugs into a Genesig Q16 desktop device that the company says analyzes the samples and returns results in about an hour, and can process up to 100 samples a day.

Most PCR tests for Covid-19 today require sending swabs to a remote lab for analysis. In the U.S., the rapid rise of Covid-19 cases and demand for testing is causing analytical backlogs of a week or longer, sharply reducing the usefulness of the tests.

The clinical trial is recruiting 2,000 participants at 50 long-term care facilities known as care homes in the U.K., including staff and visitors as well as residents. The 50 care homes are randomly divided to receive daily tests with a Genesig Q16 device or standard Covid-19 tests sent back to a lab for analysis taken once a week. The research team from Queen Mary University will look particularly for Covid-19 infections after 21 days, but also infection rates after 14 days, as well as hospitalizations and deaths from infections. The team plans to use simple mid-nose swabs in the trial, compared to more invasive nasopharyngeal swabs taken from the back of the throat used up to now.

The researchers are led by Joanne Martin, professor of pathology at Queen Mary University, and president of the Royal College of Pathologists. “This work has the potential to bring a new rapid Covid-19 testing system to those at highest risk, and help interrupt community transmission,” says Martin in a statement. “If found to be successful in care homes, it could be very useful in a wide range of settings, helping to make a quick diagnosis and keep an environment free of Covid-19.”

“With rapid daily testing,” Martin adds, “we can report back to the care home on the same day, so that they can take action to reduce transmission in their care home and prevent outbreaks into the wider community.”

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