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Industrial Technology Research Institute


Breakthrough in COVID-19 Testing: ITRI Develops Nucleic Acid Detection System for 1-Hour Rapid Tests

ITRI’s Nucleic Acid Detection System can detect early infection in the incubation period when the viral concentration is still low and provide test results in one hour.
ITRI’s Nucleic Acid Detection System can detect early infection in the incubation period when the viral concentration is still low and provide test results in one hour.

Amid the war against the COVID-19 pandemic, ITRI is turning to its technological prowess to fight the virus and prohibit its spreading. The institute has formed a task force focusing on molecular rapid testing with the joint efforts from the industrial, public, research, medical, and epidemic prevention sectors, and officially introduced its nucleic acid molecular detection device and kit on April 15. This test is precise, sensitive, efficient, and easy to carry around. It weighs only 600 grams, enabling medical personal to take the kit with them wherever they go. It also yields results within 60 minutes with an accuracy of over 90%. Over the next few months, it is hoped that more companies will participate in the production of the device and kit, forging an even broader effort to fight the pandemic.

ITRI President Edwin Liu remarked that COVID-19 is believed to become more “influenza-like” in the future and that the proportion of mild cases will be quite high. Consequently, how to quickly diagnose at medical centers or clinics whether people have been infected will be crucial to halt the spread of infection. Taiwan is currently among the best in the world in controlling the outbreak, and as of April 15th, 86% of the total number of confirmed cases here are imported ones. This figure highlights the importance of border screening. If authorities are able to block the epidemic at borders, they will be able to effectively contain the virus’ spread. Dr. Liu indicated that ITRI hopes it can work with Taiwan Centers for Disease Control in introducing the nucleic acid molecular detection device and kit for rapid testing in medical centers, community clinics, or airports/ports. This “Moving Lab” method will allow individual tests to be conducted efficiently, which will shorten the waiting time for the test results from 48 hours to 1 hour and thus significantly reduce the manpower and costs for virus screening.

The Director of Institute of Preventive Medicine at National Defense Medical Center Po-Shiuan Hsien expressed that amidst the COVID-19 outbreak, his Institute, which focuses on bio-protection research, has obtained preliminary results in rapid tests on viral antigens. The collaboration with ITRI allows the two parties to work together on the development and verification of the nucleic acid detection system. He hopes that the goal of mass production can be achieved as soon as possible as to ensure public health. A Member on the Board of Supervisors at Taiwan Society of Laboratory Medicine and Chief of Institute of Medicine at Chung Shan Medical University Hospital Ming-Chang Hsieh also pointed out that ITRI’s innovation featuring one-hour rapid testing for COVID-19 would be a great advantage for clinical tests. The expansion of testing capacities will surely relieve the burden of medical workers in clinical tests.

ITRI Vice President and Biomedical Technology and Device Research Laboratories General Director Chii-Wann Lin commented that the methods of detecting COVID-19 include viral nucleic acid molecule detection, viral nucleocapsid/spike protein detection, and immune antibody detection, which can be applied in incubation, infection and recovery periods respectively. Using a same technique with qPCR, ITRI’s viral nucleic acid molecule detection system can detect early infection from Day 0 to Day 7 in the incubation period when the viral concentration is still low, with 90% accuracy. The highly efficient kit offers results in just one hour, which is 75% faster than traditional tests. In addition, the canister weighs only 600 grams, while traditional testing devices weigh 57 times that amount. This makes the device portable and convenient for medical personal, who will be able to carry out small-scale rapid tests.

To enable intensive production, ITRI has cooperated with industrial partners, government sectors, research institutes and medical centers including Institute of Preventive Medicine of National Defense Medical Center, hospitals and four companies. It is expected to complete 10,000 thermostatic nucleic acid amplification probe reagent kits in ITRI’s GMP pilot plant by the end of June. With more companies’ participation, ITRI hopes to transfer the technology by the end of July and get prepared for mass production, with the aim to provide an accurate rapid testing solution for the frontline efforts in pandemic prevention.

Features of the Nucleic Acid Molecule Detection System

Feature Explanation
Precision Using a same technique with qPCR, with 90% testing accuracy
Lightweight Portable design at only 600 grams, which is 1/57th the weight of traditional equipment
Sensitivity Can detect early infection in the incubation period (0-7 days)
Efficiency Shortening test time from 4 hours to 1 hour, thereby reducing manpower needs