linkedin25 Feb 2020 19:57
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 des