Is the 2019-nCoV virus present: yes or no? It’s a simple question many around the world are asking as worries grow over the spreading coronavirus. A detection kit launched at the end of January by Primerdesign, a business unit of diagnostics group Novacyt, is one of the first to deliver an answer – and it does so within two hours, meaning that all samples can be screened quickly.
Paul Eros, Corporate Business Development Director at Novacyt, explained that upon identification of a new strain of the coronavirus in Wuhan, before the Chinese province found itself the subject of worldwide attention, Primerdesign had correctly identified the outbreak as an emerging global issue – rather than a domestic concern – that required immediate tackling. The decision was made to quickly develop a coronavirus assay in direct response: the genesig 2019-nCoV test.
On January 30, the WHO declared the 2019-nCoV outbreak a global emergency; one day later, the Primerdesign testing kit was ready to be launched. In the days since interest has rocketed. In less than one week, orders and enquiries have been received from more than 30 countries, with demand concentrating in Asia, the Middle East and Europe. A robust supply chain is ensuring that this demand is met, with all labs expected to be running full validation of testing with the kits by the end of the week.
Unsurprisingly, Novacyt attracted a lot of attention at Medlab Middle East 2020, which concluded last week. Around 80 per cent of enquiries at their stand was in about the coronavirus assay, we were told.
The Primerdesign team is now looking at putting the genesis 2019-nCoV test through the FDA emergency use programme, and in Europe through a CE-IVD validation process to receive mark approval within the next two weeks.
Coronavirus detection kit designed specifically for 2019 virus
Eros attributed the surge in interest to the test’s sensitivity and ability to detect only the 2019 strain of the respiratory virus. This differentiates it from other current tests, which are less specific, possibly reacting to related species such as SARS and MERS and giving rise to a false diagnosis.
The Primerdesign test is also stable at ambient temperatures, which eliminates the need for cold chain shipping in tropical climates, therefore, improving the efficiency of the test and reducing transport costs.
Cost-wise, Eros added that the test represents exceptional value compared to some of the next-generation sequencing technologies, which are being used to test for the virus.
Coronavirus detection kit portability ideal for emergencies
Getting started with a genesis 2019-nCoV kit is straightforward for experienced PCR users. In the event that they’re running a real-time cycler from the likes of ABI or Rotor-Gene or LightCycler, they will be up and running quickly. Training will, however, be required for any new or inexperienced PCR user.
The test’s flexibility was also highlighted by Eros: it’s designed to run on multiple molecular testing platforms, including Primerdesign’s gensig q16 and q32 instrument, and can, therefore, be used in large and small laboratories as well as remotely where necessary.
When asked about the possibility of using the detection kit in a mobile situation, Eros revealed that the genesig q16 (weighing no more than 1.5Kg) can be run off a battery, making testing possible for an emergency. He nonetheless cautioned that it wasn’t a true point-of-care test.
How to acquire the Primerdesign coronavirus detection kit
Anyone interested in placing an order is encouraged to contact Primerdesign through their website at www.primerdesign.co.uk.
Randox to launch new coronavirus test
At Medlab Middle East, Randox Laboratories also announced that the company is in the final stages of developing a test for the potentially fatal 2019-nCoV strain of coronavirus.
The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate 2019-nCoV testing, but an additional enhanced multiplex array will also include tests for other respiratory viruses, which can display the same symptoms.
The new Biochip will, therefore, allow clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr. Peter FitzGerald, Managing Director of Randox Laboratories, commented: “Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of 2019-nCoV, and, therefore, neglect to differentiate between this strain and other respiratory infections.
“Whilst we’re very quickly developing an efficient novel test for this new strain of coronavirus, we are, therefore, also working on an extended Viral Respiratory Infection Array that will test simultaneously for 2019-nCoV and a range of other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found and empower clinicians to make fast and informed decisions.”
The test will reportedly be available for the Point of Care analyser, the Vivalytic, within 3 hours, and within 5 hours on the Randox Evidence Investigator.
Benefits of the new Randox 2019-nCoV test
• Quick turnaround times
• Multiplex array differentiates between mild and serious infection
• Automated and semi-automated options available