Recently, Professor Zhou Rong and Associate Professor Liu Wenkuan’s research team from Guangdong Nanshan Institute of Pharmaceutical Innovation and the Industry-University-Research Base of the Lab have made new breakthroughs in the research of nucleic acid extraction. They developed a throat swab solution without the need to extract viral nucleic acid (RTU) that integrates the collection, inactivation, and extraction of virus samples.

It is reported that it greatly simplifies the whole process of conventional viral nucleic acid extraction, with a more convenient operation process, simpler components, and greatly reduced workload and waiting time. It can not only meet the demands of second-tier hospitals for nucleic acid testing anytime anywhere, but is also suitable in cities and regions where equipment and professionals are in shortage. Currently, the reagent has been patented and registered as Medical device of Class I.

The reagent integration process of collection, inactivation, and extraction of virus samples

1. The launch of RTU can effectively solve the bottleneck problem in nucleic acid extraction

The COVID-19 epidemic is still raging around the world. As the standard testing for COVID-19, nucleic acid testing has played an important role in the prevention and control of the epidemic.

Nucleic acid testing is composed of two parts: nucleic acid extraction and PCR amplification. Nucleic acid extraction has always been an important step in the entire testing process. The most commonly used magnetic bead-based extraction reagent or nucleic acid extraction instrument not only has many components, but also has a longer process, which takes about 20-60 minutes, greatly limiting the detection process. However, RTU can greatly shorten the time from collection to on-board detection to only 3 minutes and 30 seconds, solving the bottleneck problem in nucleic acid extraction in terms of time and speed.

Comparison flowchart of extraction between RTU and magnetic bead-based extraction

Compared with similar products, RTU is extremely fast, highly accurate, highly stable, very safe, easy to operate, highly compatible, and more cost-effective. The whole extraction process can be completed in 3 steps (the operation process using RTU and magnetic bead-based extraction is shown in the figure above), which greatly improves the efficiency of respiratory viral nucleic acid testing, effectively reduces the risk of infection of the staff during the transportation and testing, reduces the protection level of the laboratory during the operation process, and saves the cost of transportation and storage, which is significant to the prevention and control of viral respiratory diseases like COVID-19.

2. RTU is patented and registered as Medical device of Class I, realizing transformational applications

Currently, the project team has carried out joint research with the First Affiliated Hospital of Guangzhou Medical University and Guangzhou Children’s Hospital, and accumulated a large number of clinical data. The maturity and reliability of the product technology have been fully demonstrated through experiments. In the clinical data of 104 samples of respiratory pathogens, compared with conventional nucleic acid extraction, the coincidence rate of the detection results using RTU was 99.04%.

Through the cooperation between GIR Medicine Company Ltd. and Industry-University-Research Base of the Lab, the reagent has been patented and registered as Medical Device of Class I (Guangzhou, Guangdong Equipment No. 20201736) for industrial transformation, and is currently being promoted and applied in the field of respiratory pathogen testing.