April 2021

Scenario Driven Fast Infection Screening & On-site confirmation for COVID-19

Yi-Shao Yang1 and Wen-Yih Chen1,2

1Helios Bioelectronic Inc., Rm. R307., No.2, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu Biomedical Science Park, Hsinchu 30261, Taiwan

2National Central University, No. 300 Jhong-Da Rd., Jhongli, Taoyuan 32054, Taiwan

A scenario like this:

Michael has a global business and must travel interstate and internationally. However, due to the pandemic outbreak, Michael has been trapped in Taiwan for over 4 months. He, like many other businessmen, has been waiting for a solution to travel without the risk of getting infected. And more importantly, the border control and quarantine policies of many of his destination countries need an effective way to facilitate the re-opening of business while maintaining the low risk of the disease spreading as well.

The digital “immunity passport” not “vaccinated passport” initiated by the World Health Organisation (WHO) could be a future solution for the situation. However, the implementation and practice of such an idea requires new technologies to be ready where they are needed – for example, a quick yet sensitive screening test to be carried out immediately before the traveller checks in for the flight or immediately after the flight lands but before immigration clearance. The results are uploaded and incorporated into the cloud database by the integrated transmission circuitry on the same semiconductor biosensor used for serological and molecular tests, which makes the test machine portable and easy to use. The immigration authority and border control agency access the encrypted data and evaluate the risk of the incoming travellers or passengers on the outbound flights.
Michael was on his way from Taiwan to Korea He arrived at the TaoYuan International Airport three hours prior to departure. Before he checked in for his flight, he went into a booth located next to the airport entrance. The booth looked no different from any telephone booth you would find on the street; however, it equipped with a small machine with a screen showing the procedures Michael must follow for the serological and molecular tests for COVID-19. It took Michael about 15 minutes to complete the test, then he went to the airline counter for check-in. With the embedded circuitry and analysis algorithm, the test machine transmitted the analysed data within 15 minutes, showing there is neither viral infection nor IgG/IgM responses in Michael’s tests. With Michael at the check-in counter, the database connected with airline ticketing and immigration systems suggested to the ground staff and immigration officers that Michael had low risk of spreading the pandemic disease; however, Michael was at risk of getting infected because the tests Michael took showed he did not have enough neutralizing antibody to protect him from SARS-CoV-2 infection.

With the encrypted information showing only a binary yes or no regarding whether Michael is safe to travel or not, the ground staff issued the boarding pass for Michael since his tests came back negative of infection. The ground staff also asked Michael to sign a waiver form, showing he understood the risk he took of getting infected during the flight: this was due to the ground staff noticing the negative neutralizing antibody test showing in Michael’s test results. Michael signed the waiver form without hesitation because he had received the test results on his mobile phone on his way from the test booth to the check-in counter, and he understood his risk of getting infected but he felt safe because he trusted the procedure he just experienced. He believed the system had lowered that risk by alerting the airport and border control officials the potential asymptomatic COVID-19 patients from flying with non-infected passengers. Michael also felt financially relieved because, with the test certificate, he successfully purchased the travel insurance covering the potential costs he might incur if he did get infected during his travel. With his boarding pass and the signed wavier form, Michael went on to the immigration station where he was notified by the Immigration Officer of his test results and he was issued a digital “immunity certificate” as a required document for his travel.

At his time of departure, Michael boarded the airplane as in the past, except this time, in addition to his passport and boarding pass, he had his immunity certificate and the wavier form with him. This was his entrance ticket for the point of entry of his destination – Heathrow Airport, London, England - where he would be welcomed.

Fundamental elements of Interoperability for this case are:

  • ● Agreed treats and protocols among countries for pandemic control.
  • ● Medical device for measurements of viral RNA, viral antigen and other protein biomarkers as the surrogate for efficacy or as identification of disease and immunity response.
  • ● Devices that track and record travel records.
  • ● System that record, encrypt, and transmit the measurement results, travel records and personal information.
  • ● Treats and protocols among countries for information exchange and agreed/coordinated quarantine policies.
  • ● COVID passport: electronic passport that records the necessary information, including general travel documents, travel records, and medical records, i.e. viral RNA and antigen test results, personal immune responses and or vaccination records.
  • ● Insurance policies for travel with COVID passport.

Potential quarantine policies for this case are in discussion in Taiwan:
At departure:
  • • 3 Days before: Nucleic Acid Test.
  • • On the day of departure: Antigen test and antibody test
  •   • Negative on all three tests: issue COVID-19 free certificate, issue boarding pass.
  •   • Negative on nucleic acid and antigen test, antibody test positive (IgG or IgM positive): infected, not contagious, issue boarding pass.
  •   • Positive on nucleic acid or antigen, antibody test negative: early stage, on-set of infection, contagious: quarantine at home, designated hotels or hospitals.
  •   • Positive on nucleic acid or antigen, antibody test positive: mid stage, contagious: quarantine at home, designated hotels or hospitals.

At departure:
  • • Check COVID-Free certificate, Nucleic acid test, Antigen test and antibody test:
  • • Negative on antigen test + COVID-free certificate: quarantine at designated hotel or at home, waiting for nucleic acid test results:
  •   • Positive: new infection, quarantine at designated hotel, home, or hospital.
  •   • Negative: end of quarantine.
  • • Positive on antigen test + COVID-free certificate: quarantine at designated hotel or at hospital, re-test antigen test after 1 day and waiting for nucleic acid test results.
  •   • Re-test positive: quarantine and hospitalized, waiting for nucleic acid test results.
  •   • Re-test negative: quarantine at hotel or at home, waiting for nucleic acid test results:
  •     • Negative: end of quarantine.
  •     • Positive: quarantine and hospitalized.
  • • Negative on antigen test and no COVID-free certificate: quarantine at designated hotel or shelter, waiting for nucleic acid test results:
  •   • Positive: quarantine at designated hotel, home, or hospital.
  •   • Negative: end of quarantine.
  • • Positive on antigen test and no COVID-free certificate: quarantine at designated hotel or at hospital, wait for nucleic acid test results.
  •   • Negative: re-test – negative: end of quarantine, positive: quarantine and hospitalized.
  •   • Positive: quarantine and hospitalized:

This scenario driven COVID disease management provide us, as scientists, what and how to work on our research projects to target the unmet needs of this pandemic era of us.

Note: This article is written by YSY with minor modifications by WYC. YSY is the Chief Operation Officer of Helios Bioelectronics Inc., Taiwan, and WYC is the co-founder of Helios Bioelectronics Inc., Taiwan.