Development of a fully automated multiple specimen testing method for COVID-19

Signing of a joint research contract with the Kitasato Institute and Toyobo Co., Ltd. Toward the development of a fully automated multiple specimen testing method for COVID-19 using the pooled method^*1

On January 29, 2021, Tsubakimoto Chain Co. (Headquarters: Kita-ku, Osaka, President: Yasushi Ohara) contracted with the Kitasato Institute (Location: Minato-ku, Tokyo, Chairperson of the Board of Trustees: Hirosuke Kobayashi) and Toyobo Co., Ltd. (Headquarters: Kita-ku, Osaka, President: Seiji Narahara) to carry out joint research concerning the establishment of a revolutionary method for COVID-19 testing using next-generation automation technology enabling testing of multiple specimens.

This research theme is one adopted as a means of supporting empirical research aimed at the realization of early and copious infection testing, with respect to the call for Proposals for COVID-19 Related Research, supported by the Japan Agency for Medical Research and Development (AMED). The research aims at fusing the core technologies possessed by the Kitasato Institute, Toyobo Co., Ltd. and Tsubakimoto Chain Co. in order to bring about the early introduction of a fully automated multiple specimen testing system based on the pooled method^*1.

Background

1. Joint research background

We are now in the throes of the third wave of the worldwide COVID-19 pandemic. The development of copious testing methods and reduction in treatment time are becoming urgent issues for the purposes of grasping actual infection circumstances and providing appropriate medical treatment. To these social issues, the research aims at building a creative and revolutionary testing system by combining the Kitasato Institute's implementation system for its COVID-19 Countermeasure Kitasato Project and its undertakings, Toyobo's reagent technology for research based on DNA polymerase, and Tsubakimoto Chain's automation technology. We look to complete empirical research experimentation by the end of March 2021 and to develop practical applications in June 2021.

2. Main points of the research

The pooled method is one method of multiple specimen testing, in which nasopharyngeal swab fluids, saliva and so on taken from multiple individuals are tested as a unit. Researchers look to this method as a way of reducing inspection time and expenses compared with methods based on testing of individual specimens. Until now, in tests employing the pooled method, attempts to treat multiple specimens at one time have resulted in the specimens of infected persons being diluted by those of healthy persons, causing problems such as a lowering of detection sensitivity.

The present research will establish a next-generation, fully automated multiple specimen testing method that, via reliability of testing, improvements in safety, and shortening of the time from the collection of specimens to determination of results, is capable of copious specimen tests. Aiming at bringing about PCR testing that is highly precise and copious and of relieving inspectors of the risk of infection, we will engage with the technological issues noted as follows.

1. Actualizing multiple specimen testing (13,000 specimens/day) according to the pooled method and operation of an error-free specimen ID management system.
2. Establishing an inspection method requiring no troublesome RNA purification process, based on the latest DNA polymerase technology.
4. Implementing an Automated Mini-laboratory, a fully automated testing system with the human element removed and capable of operating even at night.
5. Applicable as well to infection testing other than for COVID-19

Features

Overview and features of Tsubakimoto Chain's automated equipment, the Automated Mini-laboratory

We are in charge of the specimen ID management system and of the practical application for a highly efficient, fully automated testing system with the human element removed and capable of operating even at night. These will give full scope to the testing technologies of the Kitasato Institute and of Toyobo.

1. Overview of the Automated Mini-laboratory
   

   

   Composed of three units: A dispensing unit, a concentrating unit, and a pretreatment/PCR unit. The three units are robot operated. They are designed to be fully automated from the reception of the specimens (marked with ID information) and on through dispensing, pretreatment, and PCR automatic testing.

2. Features of the Automated Mini-laboratory
   We aim at creating practical applications for the technological issues noted below by making use of technological abilities we have cultivated in frozen automatic storeroom for drug development and DNA research organizations. These include: (i) Robotics for picking of specimen containers and for automatic opening and closing of lids; (ii) Picking robots and interlocked automated technology for dispensing devices; (iii) Liquid handling technology for reagents as well as for DNA and blood; (iv) Automated scanning technology for IDs of specimen containers.
   1. Increasing the number of tests that can be performed at one time and constructing an ID management system for specimens. Developing a 384 Format^*2 dispensing device adapted to the pooled method and constructing a data management system for identifying targets (persons testing positive). It is adaptable to specimen containers of various shapes.
   2. Optimal parameter settings; avoidance of specimen contamination^*3 risk
      Incorporating the optimal parameters for each dispensing treatment, suction volume etc. into automatic devices, and bringing about reduced contamination risk and accurate dispensing.
   3. Adaptable to multiple specimens such as rhinolaryngological swab fluids and saliva
      Accurate, automatic dispensing of rhinolaryngological swab fluids, saliva and other specimens of differing types and for specimens of high viscosity.

Future

Future developments for this research

We intend to promote this research not only for the construction of speedy and copious testing systems at medical sites but also with an eye to its use in the establishment of specimen testing when entering the country at airports etc. as well as of testing systems at large-scale international sporting events and similar occasions.

^*1 Pooled Method: One method of multiple specimen testing, in which a portion of specimens such as of nasopharyngeal swab fluids and saliva taken from multiple individuals are tested as a unit. In the present research, there is the ability to increase the pooled numbers to over 13,000 specimens/day per system, thereby increasing the test numbers.

^*2 384 Format: Containers dispensing specimens for coronavirus PCR testing are commonly of the 96 Format, meaning they have 96 cavities (for 96 specimens). However, providing 384 cavities in an identical plate size allows the simultaneous testing of 384 specimens, four times the conventional number.

^*3 Contamination: Mixing of specimens or other material

Future

• The press release concerning this matter issued by the Kitasato Institute:
  https://www.kitasato.ac.jp/jp/news/20210202-01.html
• The press release concerning this matter issued by Toyobo:
  https://www.toyobo.co.jp/news/2021/release_1071.html

The research presented here is supported by AMED in connection with the FY2020 Program to Develop Countermeasure Technologies against Viral and Other Infectious Diseases (empirical research; modified research).

Theme Name: Establishing a revolutionary method of COVID-19 testing using next-generation automation technology enabling multiple specimen testing