Tests in 15 minutes even at small and medium-sized hospitals, margin of error less than 10%
Utilization of signal amplification and high-density antibody immobilization technologies, etc.
Technology transfer in progress... Commercialization expected in 2024


Domestic researchers have developed a technology that can measure the likelihood of cardiovascular diseases such as arteriosclerosis, hyperlipidemia, and heart attack within 15 minutes, even in small public health centers, small and medium-sized hospitals, and nursing hospitals.

The Electronics and Telecommunications Research Institute (ETRI) announced on the 3rd that it has developed "automated biomarker analysis technology" for simply testing for cardiovascular disease. A biomarker refers to a substance that can detect signs of abnormalities in the body, such as indicators like DNA and proteins.
The biomarker automated analysis technology developed by the research team measures five types of markers (CRP, D-dimer, cTnI, CK-MB, NT-ProBNP) whose protein concentrations increase during cardiovascular disease, and incorporates signal amplification technology, high-density antibody immobilization technology, and rotational motion-based automation technology.

Existing diagnostic devices were manufactured for large hospitals, so they were bulky and expensive, making widespread distribution difficult. It was also difficult to assess the severity of the disease, as testing took 2 to 3 days. The automated analysis device developed by ETRI is the size of a household microwave (490×650×350mm) and solves the shortcomings of existing diagnostic devices.

As a result, it is expected that patients at risk of cardiovascular disease will be able to prevent the condition by reducing the probability of it worsening into cardiovascular disease, as they can easily and quickly receive preliminary examinations at local hospitals rather than large hospitals.

◇ Enhancing the reliability of biomarker detection with signal amplification technology

Cardiovascular diseases such as myocardial infarction and angina pectoris develop through stages of hyperlipidemia or arteriosclerosis, and are predicted by analyzing five markers, including CRP and D-dimer, which are known to increase among about 30 markers in the blood when cardiovascular disease develops.

For example, if there is a blood clot, a D-dimer marker is found in the blood, and if the concentration is high during a blood test, it is considered that there is a relatively high possibility of developing cardiovascular disease.

The research team cited a technical principle for detecting markers in which high-density antibodies immobilized on the surface of a biochip capture biomarkers within a sample (plasma) and recognize and detect them using light of a specific wavelength.

Signal amplification technology, which is the core of this analysis technique, is designed to enhance the reliability of biomarker detection. When an antibody reacts with an antigen, it emits a light signal, and this technology amplifies that signal to make it easier to observe. High-density antibody immobilization technology enables the detection of low concentrations of protein that are difficult to observe.

The research team also incorporated a centrifugation function for blood test pretreatment within the automated analysis system.

Using the research team's module, 1 mL of blood can be pre-processed within 3 minutes, enabling easy and rapid biomarker measurement. Based on rotational motion-based automation technology, the measurement time was shortened by minimizing the travel distance of the sample and various modules.

In addition, deviations and errors caused by external factors were minimized. The researchers explained that the coefficient of variation (CV), which refers to the deviation of measurement values when continuously measuring the same sample, was measured at 3.4%, a result close to the world's highest level.

◇ Commercialization expected within 3 years after project completion

The research team plans to verify the performance of the automated analysis technology through clinical trials next year and further reduce spatial constraints by optimizing the system's structural design. Furthermore, it is anticipated that by modifying the capture and detection antibodies used in the automated analysis technology, it can be applied not only to cardiovascular diseases but also to conditions related to cancer, viruses, bacteria, and food poisoning.

ETRI has filed approximately 10 domestic and international patents related to this technology and has presented it at numerous conferences, including SPIE Photonics West. In addition, the technology was introduced at the 2019 International IoT Exhibition and is scheduled to be exhibited at the 2020 Fall Conference of the Sensor Society.

The research team is pursuing technology transfer to biosensor and medical diagnostic device companies for commercialization, and expects commercialization to be possible within three years after the project ends. This research was conducted as part of the Ministry of Science and ICT's project 'Development of AI Doctor Technology for Cardiovascular Diseases,' which runs from October 2017 to December 2011.