Online Collaboration Bears Fruit: Oncology PhD and Infectious Disease Experts Co-Develop All-in-One COVID-19 Rapid Nucleic Acid Detection Kit and Test Strips

Following the outbreak, Yao Jie, an ordinary military veteran and former Ph.D. in Oncology at the Chinese PLA General Hospital, felt once again called to duty. Witnessing the ravages of the epidemic in his hometown, he deeply empathized with the suffering. Nucleic acid testing emerged as the top priority in epidemic prevention and control efforts. However, at that time, the sensitivity, operational convenience, and testing throughput of nucleic acid tests all required improvement.

At the time, Dr. Yao held in his hands a CRISPR-based detection platform previously developed for tumors and genetically associated diseases. This system would be even more suitable for detecting exogenous viral nucleic acids. Witnessing many of his former colleagues fighting on the front lines, and driven by a desire to contribute to the fight against the epidemic for the sake of his hometown, Dr. Yao immediately reached out to these former comrades, including infectious disease experts from the Fifth Medical Center of the Chinese PLA General Hospital, as well as numerous scientific and technological professionals in the field. All expressed their unwavering commitment to stepping up in response to the pandemic.

Thus, they embarked on an online collaboration that lasted for more than 50 days. The complete set of technical documentation and laboratory equipment had to be shipped, and the procurement and logistics of various raw materials needed to be addressed one by one. Dr. Yao recounted that since the onset of the pandemic, he had been communicating with various parties via phone, video calls, and WeChat every day from 8 a.m. to 11 p.m., without any slack.

For online collaboration, in-depth analysis and control of technical details, along with seamless technical communication, are particularly crucial. Dr. Yao’s technical team and the collaborating experts maintained around-the-clock communication, sparing no effort to resolve technical issues.

Their collaboration has already yielded preliminary results. The one-stop portable case for rapid COVID-19 nucleic acid testing has been fully assembled, and clinical trials have been conducted at designated hospitals in both Beijing and Wuhan.

This testing system has the following features compared to traditional nucleic acid testing systems:

Since this detection system enables closed-tube testing throughout the entire process within a single tube, it performs reverse transcription of viral RNA immediately, followed by non-specific cleavage targeting specific sequences. This approach helps control the biosafety risks associated with the viral nucleic acid reaction process and final products to a certain extent.

Testing requires no specialized equipment; it can be performed using either a portable fluorescence detector or a standard microplate reader commonly found in laboratories. The complete set of POCT instruments and materials can be conveniently carried in a single suitcase. Notably, the nucleic acid test strips offer an even simpler approach: results are displayed directly on the companion test strips without the need for any detection instruments. This eliminates throughput limitations, enabling simultaneous testing of multiple individuals. Furthermore, it removes constraints related to instrumentation and venue, allowing for on-site testing wherever biosafety conditions permit. This solution serves as a robust complement to existing testing systems.

The test procedure involves a single-tube reaction, requiring no additional steps. Once the reagents are prepared, simply add the sample and read the results using a fluorescence detector or microplate reader, or apply the sample onto a nucleic acid test strip. The entire process takes only 60–70 minutes.

This method employs an "all-or-none" interpretation rather than relying on quantitative readings, thereby offering higher discrimination. Its sensitivity can reach within tens of copies. Compared with traditional nucleic acid testing methods, it enhances sensitivity and reduces the false-negative rate.

Current clinical sample test results indicate that for patients with clinically suspected positive cases but negative PCR nucleic acid tests, retesting with this system achieves a nucleic acid positivity detection rate of over 50%. This provides a new supplementary solution for screening virus carriers among incoming travelers.

Previous lateral flow assays have primarily detected antigens or antibodies. Integrating viral nucleic acid detection onto a single test strip would significantly expand the application scenarios for "nucleic acid testing." If the detection reagents are prepared in advance, the reaction can be initiated simply by adding the sample and incubating it at 37–40°C in a thermal cup, or even by utilizing the patient’s body heat. The reaction products can then be applied to the nucleic acid test strip for specific interpretation, allowing determination of whether the viral nucleic acid is negative or positive. This nucleic acid lateral flow assay has already been successfully developed and is currently undergoing further performance optimization and clinical testing.

The testing system has been filed for patent protection and is currently undergoing CE certification. Amid the increasingly severe global pandemic situation, we strive to continue contributing to overseas epidemic prevention and control efforts.

During the extraordinary period marked by rampant epidemic outbreaks and severe disruptions to transportation and logistics, a retired military physician with a doctoral degree remained true to his original aspirations. Heeding the call that "heroes are defined by their deeds, not their origins," he braved formidable obstacles, went against the current while adapting to circumstances, and overcame numerous difficulties. Leveraging the bonds of brotherhood and camaraderie among comrades-in-arms, he joined forces with military and civilian medical institutions as well as biotechnology enterprises in the Wuhan East Lake High-Tech Development Zone, including Wuhan Bojie Biomedical Technology Co., Ltd., to conduct collaborative remote research and development. This effort yielded the first fruit of success, establishing a new model characterized by military-civilian collaboration, online cooperation, and cross-sector partnerships.

But this is only the beginning. In addition to infectious diseases, this POCT testing system is also suitable for rapid genetic screening of tumors and genetically related diseases. Collaborative industry-academia-research projects in these areas have already been launched with multiple hospitals. It is the vision of this retired military physician and PhD holder to break through site limitations and strive to apply advanced testing technologies in the most impoverished regions and the most challenging war zones. More like-minded individuals are welcome to join and collaborate.