B-018 Compact all in one, Fully Automated Molecular Diagnostic System “ExiStation™ FA 96” in 100 minutes
Authors: Lee K , Im D , Chae H , Cho Y , Kim J , Kwon E , Kim H , Jang D , Park S , Koo S , Kim S , Eom S , Lee H , Park S , Park H , Park H 
Published: September 2023

Background

Traditional PCR method’s instruments are discrete the processes of sample collection, nucleic acid(NA) extraction, and NA amplification. As human labor is required between the instruments, there is a risk of human error, infection and contamination. Biosafety facilities such as biosafety cabinet, level D protective clothing, and negative pressure facilities are required for ensuring safe testing. To improve the testing environment, the molecular diagnostic market has developed and started using automated instruments, though, which take up larger space and take longer time to test. As a result, it is necessary to develop instrument that takes up less space and reduces testing time to a minimum, so, space and time can be saved.

Methods

In this study, we developed an automated systematic genetic diagnostic instrument. In order to carry out the entire process within one integrated instrument, automatic mechanism of de-capping and re-capping of sample tube, sample aspiration, and sample transfer were developed. The system also includes integrated key steps of NA extraction and amplification (qPCR). We developed a primer/probe design technology that can accurately detect viruses with high accuracy in performing PCR tests using extracted genes, as well as precision temperature control algorithm and optimized real-time nucleic acid amplification using reverse transcription enzymes and gene amplification enzymes. In order to carry out all these functions within one device, we maximized user convenience by developing software for instrument operation, result analysis, and a Graphic User Interface for automation

Results

ExiStation™ FA 96 is largely composed of sample processing, gene extraction, and gene amplification (qPCR). (Photo to be in poster) Sample Processing automatically opens a cap of sample tube, then transfer a required quantity of sample to cartridge. While opening the cap, the barcode attached to sample tube is automatically identified and the information required for a test is entered. After sampling, the cap is automatically re-capped and placed back in the sample tube rack. When collecting samples, it measures the sample level in the tube and indirectly check the viscosity by detecting the pressure inside the tip, minimizing aspiration errors. The Extraction step performs the function of extracting genes. It consists of three modules of 32 wells, and the number of samples can even be adjusted in eight units, so the instrument can be operated flexibly upon the number of samples requested. Then, the qPCR step follows. The ExiStation™ FA 96 setup allows simultaneous testing of up to 20 targets for 94 samples in approximately 100 min. The instrument is equipped with a HEPA filter and UV lamp to maintain clean, and since the sample tubes are inserted directly on the instrument, it is no of necessity or save the costs such as of negative pressure rooms, biosafety cabinet, and level D protective clothing.

Conclusion

ExiStation™ FA 96 is a fully automated molecular diagnostic test instrument that can quickly and accurately process large amounts of samples, while greatly reducing user risks and shortening molecular diagnostic test time.