New advances in cancer recurrence monitoring and enhancing national health security

On the 80-year journey of building and developing the Post and Telecommunications sector and 66 years of Science and Technology, many research achievements have contributed to creating a solid foundation for the country's industrialization and modernization. In that general picture, the Vietnam - Korea Institute of Science and Technology (VKIST) has emerged as a potential applied research unit, with many outstanding contributions to healthcare, industry and innovation.

One of the typical projects is the research and development of LFIA rapid test strips for application in monitoring cancer recurrence and treatment, along with detecting dangerous infectious agents. Not only has scientific significance, this research also opens up new directions in disease control, improving public health capacity and ensuring national health security in the new context.

On this occasion, the reporter had an interview with Associate Professor, Dr. Truong Thi Ngoc Lien to learn more about the research journey and development orientation of rapid test kit products in the coming time.

- First of all, I would like to congratulate you and your research team on completing the Ministry-level project "Research and manufacture of magnetic immunochromatography test strips and magnetic field measuring devices using tunnel magnetoresistance sensors for rapid quantitative analysis of biomarkers CA 15-3 and CEA" (Task code: 05.2021M001). From the results of this project, the team has developed the idea and manufactured the first prototypes of LFIA test strips to serve the monitoring of cancer recurrence. Can you share your feelings when the work was initially recognized?

Assoc. Prof. Dr. Truong Thi Ngoc Lien: First of all, I am very happy and proud that the efforts of the research team have been recognized. This result is not only a testament to the solidarity and perseverance of the team but also opens up a new direction in the development of LFIA rapid test strips for monitoring cancer recurrence. We consider this an important initial step, creating a foundation to continue perfecting the technology, moving towards widespread application in clinical practice, contributing to supporting doctors and patients in diagnosis and treatment. At the same time, applied research is also the core goal that VKIST Institute always aims for in the process of developing and implementing scientific topics.

Assoc. Prof. Dr. Truong Thi Ngoc Lien, Head of Department of Integrated Biotechnology and Information Technology, VKIST.

- Madam, what inspired you and the research team at VKIST to choose this direction?

- Associate Professor, Dr. Truong Thi Ngoc Lien: What motivated me and my research team to choose this direction originated from the COVID-19 pandemic. At that time, we clearly witnessed the difficulties in examination and treatment, especially for cancer patients - which have a fairly high incidence rate in Vietnam. From that reality, I wanted to develop a simple, convenient testing solution that could support patients in monitoring their health without being completely dependent on bulky equipment or large medical facilities.

In addition, we also determined that mastering LFIA's core technology is extremely important, because from this foundation, we can expand research and manufacture many different diagnostic products, especially in the rapid detection of pathogenic viruses. The biggest benefit of LFIA technology is that it brings the ability to perform biological testing quickly and simply, without the need for specialized equipment, helping medicine get closer to the community - from hospitals to families, from urban to remote areas. And my biggest dream is that in the future, Vietnam will have a factory producing rapid test kits that meet international standards, not only to serve domestic needs but also to reach out to the international market.

- Can you introduce more specifically about the operating mechanism as well as the highlights of this technology compared to conventional test strips?

- Associate Professor, Dr. Truong Thi Ngoc Lien: Compared to conventional LFIA test strips on the market, this product has two outstanding technical features. Firstly, the conjugated particle, we use spherical gold nanoparticles, covalently linked to specific antibodies. This technique makes the particles more stable under many harsh conditions, requires less antibodies to achieve optimal sensitivity, and most importantly, allows precise control of the number of antibodies attached to each particle. Thanks to that, we can adjust the detection threshold so that the test strip only displays the signal line at the correct clinically significant abnormal level, thereby supporting earlier and more effective diagnosis, minimizing false negatives or false positives, and ensuring high consistency between production lots. Secondly, the sample receiving area is integrated with a blood separation membrane. Users can directly drop whole blood onto the test strip without the need for serum separation by centrifuge as in the traditional process. Users only need to take 1-2 drops of capillary blood from the fingertip, drop directly onto the test strip and after a few minutes have results with high accuracy and reliability. This simplifies the operation and increases the convenience when using at home while still maintaining the accuracy and high reliability of the results.

While current testing methods require expensive equipment and highly specialized human resources, the rapid test kit for detecting cancer markers based on LFIA technology stands out with its advantages of convenience, speed and low cost. In particular, the kit can be easily performed at home, helping to reduce the burden on hospitals, while creating conditions for many patients, especially in remote areas, to access early diagnosis and treatment monitoring without having to bear the financial burden.

Associate Professor, Dr. Truong Thi Ngoc Lien and her research team at VKIST.

- What are the initial test results, madam?

- Associate Professor, Dr. Truong Thi Ngoc Lien: We have conducted clinical trials on more than 40 blood samples of cancer patients and nearly 200 blood samples of healthy people. The results show that the sensitivity is over 98%, and the specificity and reliability are over 99.6%. With the test strip detecting breast cancer markers (CA15-3) and colorectal cancer markers (CEA), the sensitivity is over 98% and the specificity and reliability are over 99.6%. For the test strip detecting hepatitis B virus, the accuracy is also over 99.5%. Although the number of samples is currently limited, these results have shown the great potential of the product. In the coming time, we will continue to expand clinical trials on a larger scale and in multiple centers to confirm the stability and reliability before moving forward to develop commercial products.

With the prototype phase tests, we have obtained positive signals. We have evaluated the basic technical parameters of the product, including sensitivity, specificity and reliability at the laboratory scale, using standard antigens as test samples. The initial results show that the product meets these criteria well, creating a solid basis for us to continue the clinical testing steps on real patient samples. However, it should be emphasized that it is still at the prototype stage and cannot be considered a commercial product.

Although the number of samples tested is limited at present, these results have shown great potential of the product. In the future, we will continue to expand clinical trials on a larger scale and multi-center to confirm the stability and reliability, before moving forward to commercial product development.

- Could you share more about intellectual property protection and expectations for product commercialization in the near future?

- Associate Professor, Dr. Truong Thi Ngoc Lien: During the research process, we paid great attention to intellectual property protection to create a solid foundation for commercialization. Up to now, the group has submitted 03 patent applications related to test strips to detect the cancer marker CEA, test strips to detect the surface antigen of the hepatitis B virus (HBsAg) and test strips to detect bacteria causing hospital infections with integrated solutions for sampling from the air environment. Up to now, all three applications have been accepted as valid. These are important steps for us to perfect the technology, cooperate with manufacturing enterprises, and expect to bring products to the market in the near future, meeting the needs of fast, convenient and reliable testing for the community.

- During the implementation process, what difficulties and challenges did the research team encounter? And what was the decisive factor that helped the project achieve its current initial success?

- Associate Professor, Dr. Truong Thi Ngoc Lien: During the implementation process, we encountered many difficulties, especially limitations in funding and experimental infrastructure. However, the key factors that helped the group achieve initial successes were perseverance, creativity, interdisciplinary cooperation between scientists and, most of all, working with all our heart. We hope to continue to receive support from the Ministry of Science and Technology and research support funds to be able to complete the prototype and expand the scope of clinical trials. Furthermore, our goal is to launch commercial products for cancer diagnosis and monitoring, and at the same time apply them to many other infectious diseases, contributing to improving the quality of public health care.

- Besides detecting and monitoring cancer, what other applications does this research direction open up?

- Associate Professor, Dr. Truong Thi Ngoc Lien: In addition to applications in cancer diagnosis and monitoring, this research direction also opens up many other prospects. In particular, with the H5N1 virus detection test strip, we have tested it on isolated virus samples and poultry samples with infectious bronchitis. The results showed that the selectivity reached 100% and the sensitivity of H5N1 was equivalent to the Ct 35 threshold of the PCR test - a result that we are very proud of. In parallel, the group has also developed an integrated solution for bioaerosol sampling and immunochromatography technology to quickly detect airborne microorganisms such as E.coli, Klebsiella or Pseudomonas aeruginosa. If we continue to improve and build a production process on a commercial scale, the product will have a reasonable price, not only serving public health but also having application value in agriculture and livestock - contributing to disease control, ensuring food safety and minimizing economic losses.

- In the future, does the group plan to expand its research to higher technologies?

- Assoc.Prof.Dr.Truong Thi Ngoc Lien: With a long-term vision, I hope that our interdisciplinary research group will become a reliable R&D address for businesses. The group is ready to accompany in research contracts to improve existing products or develop new products according to business orders, based on the group's strengths in biotechnology and advanced materials. Thereby, we expect to create solutions of practical value, contributing to promoting innovation and improving the competitiveness of Vietnamese businesses.

In the medium-term plan, we aim to commercialize rapid test kits for cancer markers as well as bacteria and viruses that cause infectious diseases. At the same time, the group also focuses on developing and launching DNA/RNA extraction kits based on LFIA technology - a product that can replace current imported kits. The outstanding advantage of this kit is that it takes only 3-5 minutes to perform, when all the steps of cell disruption, washing and DNA/RNA recovery have been integrated into the material of the separation stick, completely without the need for any additional equipment. The product cost is only 1/3 to 1/5 compared to commercial kits. The key point that makes the difference is the application of cold plasma technology to create a buffer zone to help retain DNA/RNA and recover it easily. This is a new direction, both shortening the operation time and significantly reducing costs, suitable for both research and practical applications in medicine and agriculture.

- On the occasion of the 80th anniversary of the establishment and development of the BC&VT - S&T sector, what message do you want to send to the young generation of scientists?

- Associate Professor, Dr. Truong Thi Ngoc Lien: The path of scientific research is full of challenges, requiring perseverance and passion. I always believe that "if you keep going, you will get there". I hope that the young generation of scientists will maintain their aspirations and boldly venture into new fields where there are still many "white areas" that need to be explored. Research success is not only measured by the number of international publications, but more importantly, by products and technologies that actually enter life, contributing to improving the quality of health care and sustainable development of the country.

- Sincerely thank Associate Professor, Dr. Truong Thi Ngoc Lien!

Center for Science and Technology Communication

Source: https://mst.gov.vn/buoc-tien-moi-trong-theo-doi-tai-phat-ung-thu-va-tang-cuong-an-ninh-y-te-quoc-gia-197250924201144568.htm