HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device.

From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours.

The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd., a company co-founded by Wen Weijia, a professor at HKUST’s department of physics, and his doctoral graduate student Gao Yibo.

PCR technology is reliant on the speed at which temperature rises for the extraction of viral RNA from amplified DNA fragments. So the team led by Wen Weijia, a professor at HKUST’s Department of Physics, developed a novel silicon-based micro-heater module that can perform that function faster than the semiconductors in conventional large-scale PCR devices.

“The key to getting the diagnostic results in merely 40 minutes lies in a novel material that we developed. It is a silicon-based micro-heater that has superb thermal conductivity. Compared to the conventional PCR technology, our micro-heater can speed up temperature rises, which can significantly shorten the time needed for diagnosis,” Gao, the CEO of Shineway Tech, told BioWorld.

The micro-heater could speed up temperature rises to around 30 degrees Celsius per second from an average of 4-5 C per second in conventional PCR devices, reducing the detection time of the device.

“Among all the quantitative real-time PCR tests available on the market, ours should be the fastest,” said Gao.

The detection device uses standard rapid testing tools, not unlike those used for influenza. A quick screen and a sample is taken from the nasal cavity, which is then put into the analyzer for testing.

With measurements dimensions of just 33 cm long, 32 cm wide and 16 cm high, the equipment set is light and portable. This feature makes it suitable for rapid on-site testing in places such as centers for disease control and prevention, customs, entry-exit inspection points and quarantine departments, as well as nursing homes for the elderly.

The new device is already in use by the Centers for Disease Control and Prevention (CDCP) in Shenzhen and Guangzhou, while two more sets are being delivered to the CDCP in Hubei and Nansha.

Each device is packed with a microfluidic portable PCR analyzer, a pre-processing instrument, a bioassay chip and the novel coronavirus nucleic acid detection kits. It can test up to eight samples at the same time.

The core team behind it, which consists of researchers or graduates of HKUST, started looking into adapting the test immediately after obtaining the new coronavirus sequence on Jan. 20, and came up with the testing kit within a week.

The team understands that there will be high global demand for the diagnostic kit, which they hope to meet.

“We are looking for suppliers to scale up production as soon as possible. The suppliers we contacted are supposed to resume operations on Feb 10, as the holidays have been extended, but the actual date has not been confirmed yet,” said Gao.

The extension of the Lunar New Year holidays in China is aims to help contain the spread of the coronavirus, but it may present a challenge to global supply chains.

Primed for use in international markets

Luckily, Shineway Tech’s device already has the international CE certification (EU standard) under its belt and is qualified for export to all European Union (EU) countries as well as Hong Kong.

“Our device has already been in commercial production in Shenzhen since 2017. It can also be used to detect other pathogens such as swine flu and enteropathogenic E. coli. That’s why our device obtained the international CE certification before this coronavirus outbreak,” said Gao.

This should help it reach other markets fast, where demand for tests and other coronavirus-related items are already high.

On Feb. 4, the U.S. FDA enabled the emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The use of the test, usually limited to use at CDC laboratories, is now greenlighted at any CDC-qualified lab across the country.

Stephen Hahn, commissioner for the FDA, hailed the opportunity to distribute this diagnostic test to qualified labs as “a critical step forward in protecting the public health.”

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S. government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible,” said Hahn.

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