Future

 The realization of our test kit will make it easier to identify the presence of infection and contributes to the reduction of contact with infected persons. Our test kit can be used at home, so people don't have to go to a medical institution to test. Negative test results allow people to go outside with peace of mind and prevent the spread of infection, especially by asymptomatic patients. As a result, more effective suppression of infections will be realized, which is expected to reduce the number of infected persons.

ELSI(Ethical,Legal and Social Isuues)

Ethical issues

  We need to be careful when handling DNA. The test kit we propose does not amplify and use viral DNA / RNA. Therefore, it does not have a large effect on the environment outside when it is used.

 Considering the possibility that viruses and DNA in the test solution after the test may affect the environment and the human body, the solution should be treated with heat and discard. The heat treatment kills the virus, making it possible to dispose of the solution safely to humans and the environment. Since DNA is heat resistant, it is finally disposed of by incineration or melting of any type.

 If the solution is not treated sufficiently, the environment and the human body may be affected. Therefore, we must ensure that all solutions are processed. As one of the methods, we propose that those who used the test kit send us it with their address, and we will then process and dispose of it. 　

Legal issues

 Since the synthesized DNA molecule is not a living organism, the DNA used in our test kit is exempt from the "Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms"(2003)(Called Cartagena Act)(10).

 To consider the impact on the environment, it is considered necessary to treat the used test solution to destroy the DNA and virus in it.

Social issues

 It is unlikely that our test kits will be used for viral weapons or other purposes because HCR amplifies just double-stranded DNA, not the virus itself.

 Also, the initiator that starts HCR is generated from the aptamer complex that specifically reacts with the spike protein of SARS-CoV-2. Therefore, this test kit is considered not to be abused differently from its original purpose.

Reference

(10)Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Act No. 97 of 2003)

https://www.env.go.jp/en/laws/nature/act_csubdrlmo.pdf