This new device is not only low-cost and easy-to-use but was also reported to have a very high level of sensitivity, specificity, and accuracy, similar to the qPCR test.
Recently, Pluslife Biotech, an enterprise based in the Greater Bay Area, launched the first handheld COVID-19 Nucleic Acid Test to help with epidemic prevention and control.
Hong Kong has been severely hit by the latest wave of COVID-19 infections in recent weeks. In response to challenges including the lack of manpower for pandemic prevention and control, and the limited testing capacity, the Hong Kong SAR government has rolled out a universal programme, distributing testing kits and allowing the residents to test themselves for COVID-19. Those who need to confirm the results can go to the testing stations to get additional confirmatory qPCR tests.
The Diagnosis and Treatment Protocol for COVID-19 (Trial Version 8), jointly released by the National Health Commission and National Administration of Traditional Chinese Medicine, clearly states that the positive result of nucleic acid test is the primary criterion for COVID-19 diagnosis. Compared to rapid antigen test, the sensitivity and specificity of nucleic acid test are far superior, and it can also detect infected patients at a much earlier stage. However, current common nucleic acid test like qPCR test requires expensive instruments and cumbersome operation processes, so the tests are primarily used in hospitals, third-party testing centres or laboratories. As such, qPCR test is not conducive to obtaining test results immediately at community-based testing sites.
Although rapid antigen test is simple and convenient to use, its sensitivity is significantly lower than that of qPCR test. In most cases, it can only detect strong positive samples, and if the concentration of viruses contained in the samples does not reach a certain number, there will be a probability of false negatives. Thus, in the early phases of infection, qPCR test is more accurate than antigen test.
Professor Zhou Songyang, Founder of Pluslife Biotech, said, “With the rapid spread of COVID-19 and increasing need for COVID-19 monitoring, developing suitable nucleic acid Point of Care Testing (POCT) products that are as low-cost and convenient as rapid antigen test, while retaining the accuracy and sensitivity the same as qPCR test, would be meaningful for the society as a whole to better control the pandemic.”
Pluslife Biotech is a developer and manufacturer of POCT nucleic acid testing & home-test products based in the Greater Bay Area. The company has urgently deployed the first batch of thousands of test kits for use to Hong Kong hospitals and clinics. Pluslife Biotech is a new force in the fight against the pandemic with technology, and one of the first companies in China to launch in vitro diagnostic (IVD) home-based POCT nucleic acid testing. Pluslife Mini Dock, developed by Pluslife Biotech, is the first handheld POCT nucleic acid testing product for COVID-19. The company has completed ISO13485 quality management system and CE certification and achieved sales in many regions across the globe.
Pluslife’s POCT nucleic acid testing reaches very high level of sensitivity, specificity, and accuracy, similar to the qPCR test. It also can stably detect viruses at a very low LoD (Limit of Detection). The actual stable LoD is 200 copies/mL, which is even better than qPCR test.
Moreover, Pluslife Mini Dock addresses the existing problems of dependence on expensive instruments (the single unit is usually priced at more than hundreds of thousands of Hong Kong dollars), and can achieve on-site nucleic acid testing at the grassroots level and obtain test results immediately. In terms of testing method, after taking the anterior nasal swab sample, users simply put the swab into the lysate and the test card, and then insert the test card into the Mini Dock for one-step testing and get results.
In terms of testing efficiency, Pluslife Mini Dock can detect a positive sample in about 15 minutes and confirm a negative sample in 35 minutes, significantly reducing the waiting time compared to the qPCR test (usually three to four hours with extraction, not including sample transfer time to the lab). In terms of cost, the cost of Pluslife Mini Dock is much more affordable than other POCT nucleic acid testing instruments in the market, and it is also reusable, making it suitable for large-scale use at the grassroots level.
The breakthrough of Pluslife Biotech’s highly sensitive, low-cost, easy-to-use and reliable products is supported by a team with strong innovation capabilities and a dedicated focus on technology.
Professor Zhou Songyang has decades of expertise in research and development in the field of protein engineering and other life science areas. He has published more than 150 articles as first author and corresponding author in internationally well-known journals such as Cell, Nature and Science, with total citations of more than 19,000 times. The company’s R&D team includes first batch of overseas high-level talents, professors, PhDs and senior experts in the IVD industry, who have extensive experience in core proteins, assay technologies, product structure, and stable production.
Traditional qPCR products rely on elevated temperatures and have high hardware requirements, resulting in the overall high cost of the instruments. While the majority of the existing isothermal nucleic acid testing can address the cost issue and have faster amplification speed, they cannot stably reach good sensitivity and specificity, which make them unable to be directly benchmarked with qPCR, and so for a long time, there was no well-formed POCT nucleic acid testing that could be applied to families as well as community health clinics.
To develop a high-performance POCT nucleic acid testing product, Pluslife Biotech developed RHAM, an underlying technology with independent intellectual property rights, which is different from the traditional isothermal amplification technologies such as LAMP or CRISPR detection technology.
RHAM technology shows similar performance as qPCR, and is much better than the traditional isothermal amplification technologies (like LAMP) in terms of sensitivity, stability and specificity. The wider tolerance and better compatibility of RHAM realize the one-step operation of sample processing, amplification and detection all-in-one. This process does not involve actions such as opening the lid after the amplification (no aerosol contamination), and has low requirements for external environment and hardware support. Currently, Pluslife Biotech has applied for more than 60 patents around various technologies including RHAM, many of which have been granted.
The COVID-19 testing products, represented by Pluslife Mini Dock, have opened up more scenario possibilities for POCT nucleic acid testing. According to Professor Zhou Songyang, Pluslife Mini Dock can be applied to scenarios such as customs, airport testing sites, hospital emergencies, rapid preoperative testing, mobile/field labs/testing with the military, community clinics, and even for home self-testing. Through more flexible on-site testing, pandemic prevention and control can be achieved at the source. COVID-19 patients can also be detected and quarantined early while reducing the waiting time for those with negative results. “Controlling the spread of the pandemic is of great significance to ensure the vitality of the national economy,” Professor Zhou Songyang added. [APBN]
Source: Pluslife Biotech