A Rapid Diagnostic Method with High Sensitivity without a Detection Device in 25 Minutes /strong>

Figure 1: Basic principle of SATIC method

Figure 2: Flow to judgment (procedure)

Figure 3: Test results by PCR method

Figure 4: Test results by SATIC method

Business Partnership with Nihon University, Gunma University, and Tokyo Medical University for a Rapid Diagnostic Methods for Viruses in the Field of Infectious Diseases, Including Novel Coronavirus

A Rapid Diagnostic Method with High Sensitivity that can be Visually Determined without the Need for a Detection Device in 25 Minutes of Reaction from Samples such as Saliva

Osaka, Japan, June 22, 2020 –

Shionogi & Co., Ltd.

announced today that Shionogi has agreed with

  1. Nihon University,
  2. Gunma University, and
  3. Tokyo Medical University on a license

agreement regarding a new rapid diagnostic method for viruses including the novel coronavirus (SARS-CoV-2).

We will work in collaboration with public institutions, academia including the above three universities, and partner companies to put this diagnostic method into practical use.

With continued social disruption caused by the worldwide spread of SARS-CoV-2, the spread of infection from not only patients with symptoms but also non-progressor and the infected person in the incubation period has become a major issue in the control of infectious disease.

At present, as the test methods for diagnosing patients with novel coronavirus infection (COVID-19),

PCR (polymerase chain reaction)

are used for diagnosing COVID-19 for detecting nucleic acids in viruses from samples collected from the nasal cavity, pharynx and saliva as well as antigen test kits.

However, many challenges remain with these testing methods, such as

  1. the need for specific detector,
  2. the ease and speed of measurement, and
  3. the risk of infection of healthcare workers
  4. during sample collection.

Therefore, there is a need for highly sensitive and inexpensive diagnostic methods that overcome these challenges.

The Joint Research Team,

has succeeded in developing a unprecedented innovative viral rapid diagnostic method using signal amplification by ternary initiation complexes method (SATIC method)[1].

The SATIC method is a technology

that can measure not only specific genes, but also mutant genes, as well as in-vivo molecules such as proteins and metabolites, using a simple method with high specificity.

This rapid diagnostic method using SATIC methods has all of the following features.

  1. The presence or absence of SARS-CoV-2 or influenza virus can be easily determined visually without a detector.
  2. Virus determination can be made in about 25 minutes after sample collection.
  3. There is no non-specific reaction such as false positive reaction, and high sensitivity equivalent to that of PCR.
  4. The ability to detect viruses from saliva and sputum as well as nasopharyngeal swabs reduces the invasiveness of the patient
  5. the risk of infection among healthcare workers associated with specimen collection as much as possible.

In the case of saliva, specimens can be collected by the patient themselves.

|News|Shionogi Co., Ltd.

https://www.shionogi.com/global/en/news/2020/06/200622.html