The purpose of a viral diagnostic test kit, if considered as part of public health surveillance, is to identify people who are infected with a virus and those who are not (Principles of Epidemiology, 2020). A test kit, thus, provides and potentially interprets data to facilitate the prevention and control of the targeted virus. As we learned more about test kits from interviews with experts, paper research, and stakeholders, we realized that the significance of the data and results from a viral test kit depends on the characteristics of the test kits and scenarios the test kits are used for. Ultimately, through this research, we discovered that a molecular based test would be best suited for our Viral Spiral testing kit.
Team:TAS Taipei/Human Practices
Integrated Human Practice
Project Purpose
General Purpose of Virus Test Kits
Different Types of Virus Test Kits
We first learned about test kits’ varying purposes from our interviews with Ms. Pearl Fong from United BioPharma. Ms. Fong is the Vice President of the Business Development Center at United BioPharma. At the time of the interview, United Biomedical, Inc. (UBI), the parent company of United BioPharma, was developing a COVID-19 ELISA antibody test (Zhang, 2020). Ms. Fong mentioned to us that antibody tests are designed to respond to the post-infection phase of the targeted virus. This makes antibody tests different from RT-PCR which detects for the virus’s genetic material and thus the active infection of the virus. (Interview by Derek C & Justin Y)
Figure 1: Interview with Ms. Pearl Fong over Zoom
Our speculation that different test kits had different functions was further confirmed when we attended the Taiwan Biotech Solution for COVID-19-Testing Kits online conference and interviewed Dr. Michael Jewett, from Northwestern University. In the conference, we saw a variety of Taiwanese Biotech companies producing COVID-19 tests ranging from antigen to antibody to RT-PCR tests. With our interview with Dr. Jewett, we learned that he and his team are developing a CRISPR COVID-19 test that detects SARS-CoV-2’s genetic materials. The variety of COVID-19 tests available indicated to us that there is more than one method to identify the virus. This motivated us to learn more about the different purposes behind different types of test kits so that we could pick the best one for our Viral Spiral. (Interview by Justin Y, Wilson H, & Derek C)
Figure 2: Taiwan Biotech Solution for COVID-19-Testing Kits
Figure 3: Interview with Dr. Michael Jewett
Purpose of Different Virus Test Kits
From the United States Food and Drug Administration (FDA) regulations and Emergency Use Authorization (EUA), we learned that virus test kits, specifically COVID-19 tests, are generally divided into 3 main categories: Molecular tests, Antigen tests, and Antibody tests. (Commissioner, 2020)
- Molecular tests, according to EUA’s definition, are tests that detect a virus’s nucleic acids/genetic materials. This makes tests like rt-PCR, CRISPR, LAMP, and our own test under this category. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, n.d.)
- Antigen tests detect the proteins that are part of the targeted virus. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, n.d.)
- Antibody tests detect antibodies the immune system develops in response to the virus, not the virus itself. (Commissioner, 2020)
Figure 4: FDA’s chart for the different types of COVID-19 test kits (Commissioner, 2020)
Molecular tests and antigen tests are Diagnostics Tests according to the FDA, meaning that they detect an active infection of a targeted virus. (Commissioner, 2020) Antibody tests, on the other hand, only detect for the post-infection response of a targeted virus. Because of this, the FDA has not authorized antibody tests to diagnose SARS-CoV-2 and the United States Centers for Disease Control and Prevention (CDC) DO NOT recommend using antibody testing as the sole basis for the diagnosis of acute infections (CDC, 2020).
Different Test Kits in Clinical Practice
We interviewed Dr. Sui-Yuan Chang (張淑媛) to understand more about the purpose of test kits in clinical practice. Dr. Chang is a professor at the Department of Clinical Laboratory Sciences and Medical Biotechnology at the National Taiwan University College of Medicine and has participated in several research projects that identified potential virus outbreaks in Taiwan, including COVID-19. Throughout our interview, we learned that she had used PCR, antigen, and antibody tests to identify viruses, so we asked her why she used certain tests over the other test in different scenarios. She pointed out to us that the decision to use certain types of tests mostly depends on the characteristics and behaviors of the targeted virus. If the virus, for instance, has proteins that resemble too closely with the proteins from another virus, then the PCR test is preferred more in this scenario than antigen tests. Dr. Chang’s interview led us to do more research into how test kits’ characteristics are determined. [More in Design and Execution] (Interview by Justin Y & Kelly Y)
Figure 5: Group photo with Dr. Sui-Yuan Chang
Conclusion: Our research and interviews with experts helped us confirm that the primary purpose of our Viral Spiral test kit is to diagnose active infections of our targeted viruses. Based on our HP research we believe that our project can benefit the world.
Experimental Design
RCA - Rolling Circle Amplification
Traditional molecular tests like RT-PCR are the gold standard for virus detection (Corman et al., 2020; da Costa Lima et al., 2013; False-Negative Rate of RT-PCR SARS-CoV-2 Tests, n.d.; Tahamtan & Ardebili, 2020, 2020). However, RT-PCR usually takes at least a day to produce a result, and most molecular tests, including RT-PCR and LAMP, require instruments to operate (Ge et al., 2017).
The problems of RT-PCR became obvious during the initial outbreak of the SARS-CoV-2.
- The time-consuming process for RT-PCR took up the limited capacity of the testing lab, which an NPR article pointed out in March that the multistep process of PCR being one of the reasons testing was slow in the US (Why It Takes So Long To Get Most COVID-19 Test Results, n.d.).
- And as late as August 2020, most people who were tested for the virus still did not receive results within 24 to 48 hours according to a new national survey by researchers from Harvard University, Northeastern University, Northwestern University, and Rutgers University (Mervosh & Fernandez, 2020). (NYTimes Article: https://www.nytimes.com/2020/08/04/us/virus-testing-delays.html)
The biggest problem with current molecular tests are its slow speed in producing a result and its need for an instrument which limits the test’s mobility and lowers its efficiency in producing a result.
Thus, we looked toward RCA as our solution to address the issues of traditional molecular tests as [more in the Experiments and Model]:
- RCA only takes about 30 mins to 2 hours to produce a result.
- RCA works at room temperature (~25 Celsius) and does not need an instrument to operate.
Sensitivity and Specificity Test
From our interview with Dr. Chen-Jieun Jan (詹前俊), we asked Dr. Jan to describe his experiences with rapid influenza virus test kits. Dr. Jan immediately pointed out to us that he often did not trust the results from a rapid test and mentioned to us that he would not consider using a test unless “its accuracy is higher than 90%.” (Interview by Justin Y & Kelly Y)
We further looked into Dr. Jan’s comment and realized the “accuracy” he mentioned for the test kits are in fact, the concept of sensitivity and specificity. We contacted Prof. Minchi Chen (陳明崎), who is the Professor of Public Health at Chang Gung University, and learned that the sensitivity depends on the percentage of patients that the test kit can correctly identify as positive and specificity depends on the percentage of patients that the test kit can correctly identify as negative. Prof. Chen also mentioned to us the 2 by 2 table that is used to describe the concept of sensitivity and specificity. (Interview by Justin Y)
2 by 2 table centers around 4 numbers (Lalkhen & McCluskey, 2008):
- True positive (TP): the patient has the disease and the test is positive.
- False positive (FP): the patient does not have the disease but the test is positive.
- True negative (TN): the patient does not have the disease and the test is negative.
- False negative (TN): the patient has the disease but the test is negative.
Figure 6: 2x2 Table (Graph created by Justin Y)
Definition of Sensitivity and Specificity (Lalkhen & McCluskey, 2008):
- Sensitivity is “the ability of the test to correctly identify those patients with the disease.”
- Formula: True Positive / (True Positive + False Negative) x 100
- Note: (True Positive + False Negative) = Total Number of Patients with the Disease
- Specificity is “the ability of the test to correctly identify those patients without the disease.”
- Formula: True Negative / (True Negative + False Positive) x 100
- Note: (True Negative + False Positive) = Total Number of Patients without the Disease
While researching sensitivity and specificity, we came across a Scientific American article that pointed out the same test with the same sensitivity and specificity can perform differently in different places with different infection rates. (Frasier, n.d.)
The concept the Scientific American article is describing is the other side of sensitivity and specificity: Positive Predictive Value (PPV) and Negative Predictive Value (NPV). PPV and NPV tell how much of the results from the test kit are actually true positives or true negatives.
- Positive Predictive Value (PPV): answer the question ‘How likely is it that this patient has the disease given that the test result is positive?’
- Negative Predictive Value (NPV): answer the question ‘How likely is it that this patient does not have the disease given that the test result is negative?’
Conclusion: From our research into sensitivity and specificity, we learned that in order to increase the versatility of our test kit, we need to optimize the sensitivity and specificity of our test kit to perform well under both low infection rates and high infection rates.
To increase sensitivity, We utilized a forward primer that initiates signal amplification without the reliance of additional enzymes such as RNase H or Exonuclease I to create an existing strand for polymerization. The addition of a reverse primer helps induce a branch-like exponential growth rate in signal amplification. Along with the helicase or displacement activity of phi29 DNA Polymerase from the 5’ to 3’ direction, the forward primer and reverse primer allow signal amplification to occur rapidly once even the lowest matching viral strand is detected. To increase specificty (or to make sure our test only detects selected/intended RNA targets), We selected the enzyme SplintR Ligase that proofreads full complementary between DNA/RNA hybrids before ligation, which enables direct but specific RNA targeting with our padlock probe, as there is no reliance on enzymes such as Reverse Transcriptase, which might have low fidelity. Our padlock probes are also designed to differentiate between close virus subtypes while consistently detecting the same viral subtype across a variety of cases in different locations and years. This design process was through the compilation of viral sequences from NCBI GenBank through BioEdit and optimizes the specificity of our test.
Note: We could not test for the actual number for sensitivity and specificity for our tests since finding both numbers would require the use of live virus samples from patients as indicated by EUA’s Clinical Evaluation (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, n.d.). What we did however was to improve aspects of our RCA designs that would theoretically increase the sensitivity and specificity of our test.
Saliva Sample Collection
For sample collection, we considered using both nasopharyngeal swabs and saliva in our test kit.
Nasopharyngeal Swabs
Nasopharyngeal swabs work by having a swab inserted into the nostril until it reaches the pharynx region. The swab is then left there for a few seconds to absorb secretions and removed while slowly rotating to obtain cells (Marty et al., 2020). However, from our Human Practice research, we realized nasopharyngeal swabs have several issues.
Problem 1: Nasopharyngeal swabs are difficult to operate for non-experienced sample collectors. From our interview with Dr. Shao-Lun Ho (何劭倫), a pediatrician experienced in using nasopharyngeal swabs, Dr. Ho described the process as “more of an art than science” and pointed out that it is easy for a non-experienced user/doctor to miss the targeted samples with incorrect techniques, which is problematic if we are designing a home test kit with non-experienced users in mind. (Interview by Justin Y & Kelly Y)
Problem 2: Nasopharyngeal swabs put sample collectors at risk of infection. Dr. Chen-Jieun Jan (詹前俊), another pediatrician we interviewed, pointed out that nasopharyngeal swabs often put the practicing doctor under the risk of infection and is in fact one of the reasons why clinics in Taiwan are reluctant to do virus testings. Since Influenza A, Influenza B, and SARS-CoV-2 are highly contagious viruses, using nasopharyngeal swabs could put our stakeholders at risk of infection. (Interview by Justin Y & Kelly Y)
Problem 3: Nasopharyngeal swabs are not comfortable for the patients. Personal accounts from team members who have been tested by the nasopharyngeal swabs before generally describe the experience as mostly uncomfortable with nose sore for minutes after the swab. It is even more problematic when we come across a news article, describing a woman's brain lining being punctured by the swab and leaked brain fluid from her nose (A Covid-19 Nasal Swab Test Punctured Woman’s Brain Lining and Leaked Brain Fluid From Her Nose, n.d.).
Saliva Collections
Saliva collections are self-collected and non-invasive and work by spitting into a sterile container with saline (Greenwood, 2020; Iwasaki et al., 2020; Jamal et al., n.d.; Nasopharyngeal Swab vs. Saliva for COVID-19 Diagnosis, 2020). This solved the problems nasopharyngeal swabs have as saliva collections are easy to operate, do risk the sample collector’s safety, and are more comfortable for patients to use.
However, one of the pediatricians interviewed, Dr. Si-Buo Wong (王思博), pointed out saliva collection might contain a significantly lower virus concentration than in nasal tubes. To make sure we do not sacrifice the effectiveness of our test kits, we looked through various literature on this matter. Most articles we came across have shown that saliva collection is highly sensitive and yields similar test outcomes as nasopharyngeal swabs, making saliva collection a reliable alternative to swabs (Greenwood, 2020; Iwasaki et al., 2020; Jamal et al., n.d.; Nasopharyngeal Swab vs. Saliva for COVID-19 Diagnosis, 2020). (Interview Derek C)
Plus, with increasing saliva-based tests passed by FDA’s EUA, it further reaffirms our decision to use saliva collection as our method to collect the samples (At-Home Saliva Tests for COVID-19 Could Be Coming Soon, n.d.).Therefore, we decided to use saliva collection as our method to collect viral samples, instead of nasopharyngeal swabs.
RNA as the Detection Target & RNAse Inhibitors
Our RCA design uses RNA as the targets. However, using RNA as the targets of the tests does come with the issues of RNAses. From an interview with Dr. Wen-Chien Chou (周文堅), who were experienced in working with RNA, Dr. Chou pointed out to us that RNA denatures very easily from his experience and pointed out to us that RNA can cause some issues if we want our test kits to be in a general and non-laboratory environment. (Interview by Justin Y & Kelly Y)
Figure 7: Interview with Dr. Chou
However, we decided to still use RNA as our targets primarily because a) reverse transcription takes time and instruments to operate and b) reverse transcriptase has limited fidelity (Alhassan et al., 2015; Roberts et al., 1988; Skalka & Goff, 1993). As previously we learned from our stakeholders, we wanted our tests to be highly sensitive and specific, which reverse transcriptases’ limited fidelity would limit this. Plus, if reverse transcription takes more time, it would defeat our original goal of designing a fast and convenient test.
To prevent the degradation of RNA, we utilized Protector RNase Inhibitors from Sigma Aldrich to prevent RNases from cleaving RNA sequences.
Home Test Kit: Public Survey Result
From 6/25 to 7/15, we created a public survey asking our respondents questions covering a broad spectrum of project topics. With close to 2200 people (n=2195) responses, the results of our survey ultimately helped us shape our construct design and final delivery prototype.
Since we set out to create a home test kit, we wanted to see whether people would be interested in a home test kit. When asked about whether our respondents would be willing to use the home test kit, assuming the kit is available, 93.1% (2044) of the people surveyed responded yes and 6.9% (151) responded no. When asked about whether our respondents would be more likely to get tested at home or at a clinic, assuming the tests are equally effective, 75.9% (1665) responded ‘at home’ and 24.1% (530) responded ‘at clinics’.
Figure 8: Public Survey Home Test Kit Question 1 (Graph by Tsuyoshi M.)
Figure 9: Public Survey Home Test Kit Question 2 (Graph by Tsuyoshi M.)
Since we intentionally designed our survey to see whether there’s a difference in opinions between medical professionals/students and the general public, we decided to separate the 215 medical professionals/students who responded to see their opinions on home-test kits.
Figure 10: Public Survey Respondents' Occupations (Graph by Tsuyoshi M.)
Out of 215 medical professionals/students, 93.5% (201) of them responded that they will be willing to use home viral detection kits if the test kits are available and 74.9% (161) responded that they are more likely to use a home test kit if the kit is just as effective as clinical ones. These results are almost identical to the general public responses.
Figure 11: Public Survey Home Test Kit Question 1 (Medical) (Graph by Derek C & Justin Y)
Figure 12: Public Survey Home Test Kit Question 2 (Medical) (Graph by Derek C & Justin Y)
From our public survey, we learned that people are interested in home test kits, which impacted our decision to use colorimetric readout since we wanted the public to be able to interpret their results without any formal medical training. Our public survey, however, is not reflective of the people of the regions we surveyed. We learned from our interview with Taipei American School’s Statistics teacher, Mr. David Matlock, when we analyzed the survey results. Mr. Matlock pointed out to us that our survey collected data through random sampling, so our method will not work if we want to determine how people from certain regions feel. But, what random sampling can tell us is that out of the people we surveyed, the respondents did show an interest in home test kits, which is a strong enough indication to confirm the direction of our project and we would further explore this topic in our marketing plan to bring our test kit into reality.
(Survey questions by Justin Y, with help from Mr. Jude Clapper) (Interview with Mr. David Matlock by Justin Y)
Project Execution
EUA/FDA's Guideinlines for Medical Test Kits
To make sure that our test kit fits the current medical standards of test kits, we looked into United State’s Food and Drug Administration’s (FDA) Emergency Use Authorizations (EUA), which was first mentioned to us from our interviews with test kit manufacturers and developers, Ms. Pearl Fong and Dr. Michael Jewett.
The Emergency Use Authorization (EUA) authority allows the United States FDA to facilitate the availability and unapproved uses of Medical Countermeasures (MCMs) in response to chemical, biological, radiological, and nuclear (CBRN) emergencies (Emergency Use Authorization of Medical Products, n.d.).
On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that COVID-19 and the virus that causes COVID-19 (SARS-Cov-2) a public health emergency and declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. Home collection kits were referenced in the March 24, 2020 declaration when the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products (Commissioner, 2020b).
Since our RCA test is a nucleic acid test and by the current EUA’s definition, a Molecular Diagnostic Test, this makes the EUA the most relevant medical guideline for our test kit since we are targeting the SARS-CoV-2 virus (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, n.d.). The EUA is NOT the same as getting FDA approval as once the EUA declaration is terminated, any EUA issues based on the declaration will no longer be in effect, meaning that the current 2019 EUA standards cannot be used as a long-term standard for test kit (Commissioner, 2019). This is important for us to consider since we are aiming to expand our test kit into a universal testing platform.
Even though EUA is not a long-term solution in making sure our test kits fit the standard, when we interviewed Dr. Sui-Yuan Chang (張淑媛) and asked her about the EUA, Dr. Chang pointed out to us the statistics of a test kit that EUA asks for are mostly the same medical researchers typically use to determine the performance and characteristics of a test kit. An example would be the Limit of Detection (Analytical Sensitivity) which her colleagues and her commonly used to evaluate the performance of a test kit. (Interview by Justin Y & Kelly Y)
Thus, we decided to use the EUA guidelines for Molecular Diagnostics Tests as a starting point to make sure that the data we published for our test kit is useful and relevant to the medical community. For the experiments, we focused primarily on the Limit of Detection (Analytical Sensitivity) and Clinical Evaluation.
Limit of Detection (Analytical Sensitivity)
Limit of detection (LoD) or Analytical Sensitivity is defined as “the lowest amount of analyte in a sample that can be detected with (stated) probability” (Tholen et al., 2004).
For the EUA, FDA defines LoD as “the lowest concentration at which 19/20 replicates are positive”. The protocol EUA provided recommends testing a dilution series of three replicates per concentration with inactivated viruses on an actual patient specimen, and then confirm the final concentration with 20 replicates (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, n.d.).
We took inspirations from the FDA’s protocols and tested the performance of our test kits at different dilutions. We could not fully replicate EUA’s protocols as a) we had limited probes and RNA targets for the replicates and b) we only had synthetic RNA targets to work with our lab being BSI 1. Nonetheless, the SARS-CoV-2 targets we tested managed to reach 0.027 fM for the Limit of Detection, demonstrating our RCA test’s potential of being a rather sensitive test. [More in Experiments]
Note: Limit of Detection and Analytical Sensitivity are used interchangeably (Tholen et al., 2004). Analytical Sensitivity, however, is NOT the same as the sensitivity mentioned above in our ‘Design’ section. The ‘sensitivity’ mentioned in the ‘Designed’ section is technically ‘epidemiological sensitivity’. The difference between the 2 ‘sensitivity’ is that:
- ‘Epidemiological sensitivity’ is a) typically calculated by using live samples and b) a percentage (Lalkhen & McCluskey, 2008).
- Analytical Sensitivity is a) typically calculated through dilutions of analytes and b) a concentration measured in molar concentration (Tholen et al., 2004).
Clinical Evaluation (Sensitivity and Specificity)
However, as we mentioned in our ‘Design’ section, since we do not have access to live virus samples, we could only improve our RCA Design to theoretically improve the sensitivity and specificity of our test. Though the fact EUA mentions a critical evaluation of a test kit that is similar to the considerations we make in designing our test kit does seem to reaffirm our project’s potential in benefiting the medical community. [More in Experiments]
Viral Test Kit Public Policy Proposal
Our research into societal issues helped us realize the importance of addressing societal issues while creating an innovation that is viable, which we addressed through our Education and Media Outlets. This research along with our interviews with policy makers helped clarify the limitations of our project and the limitations of technology in general, which further propelled us to think about our project in the long-term with our Marketing Plan. Ultimately, we hope that the Giant Jamboree would be the opportunity for people and biotech companies to be aware of the potential of our project, which we hope could in terms benefit the world in the long-term.
We have outlined our in depth analysis of our research into public policy proposal including interviews and conversations with Ms. Athena Hollins, who is running for the House of Representatives for the State of Minnesota, and her campaign manager Mr. Rick Brundage, where we discussed social issues associated with the epidemic in the US.
For details please read the following policy related documents:
Viral Spiral Marketing Plan
Although our project is still at a prototype stage, we want to see how our test kit will perform on the current test kit market. Therefore, we developed a marketing plan (read our marketing plan here)
In our marketing plan, to see how our test kit compared to other test kits, we looked into antigen, antibody, and molecular tests and did a SWOT analysis on each of them to analyze their respective strength and weakness. Considering that our test kit has high specificity, is instrument-free, and fast, we think that the performance of the test kit will be competitive against the other test kits.
We also analyzed the market to define the target market for our test kit. With the U.S. Food and Drug Administration now having authorized eight home test kits as of October 2020, which represents a growing market for home test kits, the United States stands as an ideal market for our home-based test kit. Specifically, we believe that targeting the market in California could be beneficial, due to California having one of the highest climbing infection rates and governmental activities conducted to expand testing capability in both symptomatic and asymptomatic people. Home test kits allow the individual to test whether he/she has a viral infection without having to do doctors’ visits, which could potentially result in an infection. This not only enables immediate results for patients to obtain early treatment and lower the chance of developing later complications but also helps relieve the strain on hospitals caused by the surge in COVID-19 cases.
From our public survey, we learned that pricing is a crucial element in deciding the usefulness of a test kit. On our survey trip, multiple people asked the question of whether the health care system will cover the cost for our test kit before they could answer the survey questions. From this, we learned that price is an important factor in an individual’s decision to get tested or not, which will be even more of the case in the U.S. where medical services cost a lot of money. Therefore, in the marketing plan, we specifically discussed the pricing for our test kit and all the factors involved. Due to the wide range of test kit prices, we initially found it difficult to price our test kit, especially since our project is still in the prototype phase. With the advice of an investor, Ms. Susan Lin, we price our test kit at $30. This price is a lot cheaper than most PCR test kits and only slightly more expensive than the cheaper-end antibody/antigen test, making our test kit competitive as well as affordable in the current test kit market.
The question about health care also prompted us to think about how we should distribute our test kits. To make the test kit as available to our target market as possible, we plan to collaborate with the California government considering its active effort in expanding test kit capability within the state. Judging from the fact that the California state government has formed a new partnership with PerkinElmer, a test kit company, in August, we believe that the state government would be able to subsidize our test kit, allowing us to price our test kit at the price of $30 or lower and making the test kit more affordable.
Education
Bioethics Panel
During March, our team hosted a roundtable bioethics panel to discuss the ethics of COVID-19. On one hand, with the wave of debates on coronavirus, we wanted to provide a space where people can share their opinions. On the other hand, we wanted to use the feedback to further shape our approach to integrated human practice. We pinpointed down three discussion points: quarantine, different cultural perspectives, and media coverage.
Figure 14:Sutdents attended our bioethics panel to discuss COVID-19 related topics
Figure 15: Wilson H. (left), Kelly Y. (middle), and Tiffany H. (right) lead the discussions for the bioethics panel
On the topic of quarantine, our discussion on an individual’s civil responsibility versus individual freedom helped us see the complexity of the topic of testing. During March, the world has not fully registered the severity of Covid-19. Therefore, our attendees have varied stances on whether an individual should sacrifice his/her individual freedom. As the virus outbreak unfortunately unfolds, we realized that the public needs to know that prevention methods such as social distancing and wearing masks is absolutely necessary in combating the outbreak. We saw a need to educate our community on the importance of following virus prevention methods. Thus, we tried to spread awareness by teaching TAS students and local school students.
Figure 16: Students and faculty listen attentively in the bioethics panel
In our panel, we also discussed the cultural impact of the virus outbreak. Specifically, we touched upon Western versus Eastern attitudes toward masks and the cultural implications behind them. Our attendees mentioned and discussed about the multiple xenophobic responses toward Asians tha occurred around March. From this, we realized just how complicated topics regarding the virus outbreak are. Ethical issues regarding race and culture play a huge role in influencing an individual’s decisions during the outbreak. Later when we did our marketing plan, we were mindful of the factor of race when selecting a target market. We hope that our discussion also helped our attendees see how diversity is heavily involved in the outbreak.
Besides moral dilemmas, we also talked about practical dilemmas such as material distribution and hogging behaviors of masks. Our attendees provided multiple perspectives on the incentives behind an individual’s hogging behavior. With this conversation, we realized that our test kit would need to address the problem with distribution, a topic which we also address with our marketing plan.
Regarding media coverage, a lot of the attendees express that they wanted the government to be transparent with the public without having the media spread too much fear. Our attendees’ responses led us to start looking into the government's role in this pandemic. Government’s organization for testing has been proven to be crucial in controlling the caseloads. With our knowledge of test kits, we wanted to help improve the government's policy regarding testing. Thus, we reached out several experts in Taiwan and Mrs. Athena Hollins in the United States and wrote a policy brief.
This bioethics panel has, in many ways, helped inform our HP research.
9th Grade Health Education + PSA
To educate our community on the importance of prevention measures, we created a health lesson plan for 9th grade health classes.
We then continued by introducing a few facts regarding the period of time it takes to develop a vaccine. We began to go more in depth with the trojan horse analogy that explains how viruses are transmitted. With this topic, we then revealed the different ways one can prevent themselves from both contracting and transmitting the virus.
Figure 17: “Trojan Horse v.s. Virus” Slide for 9th Grade Health Lesson (screenshot from presentation slides)
We also mentioned why wearing a mask is essential and showed a video of how far a person’s cough can travel, which is roughly 27 feet. In addition to that, we talked about the importance of washing hands. To visualize this, we displayed a set of images that portrays the bacteria load on one’s hands when a person washes their hands for 6 seconds versus 30 seconds. Needless to say, washing your hands for 30 seconds drastically decreased the amount of bacteria on the person’s hand. Spreading awareness about prevention methods was what our presentation was targeting, and we are glad that we got the message across with the 9th grade health lesson.
Figure 18: Tsuyoshi M. (left) and Kelly Y. (right) teaching a 9th grade health class about virus and vaccine
Figure 19: The 9th graders paying their full attention to the presentation
To further spread our message, we made the presentation into a public service announcement video which we distributed around the school. We also posted the video on our instagram account, so more people can learn the significance of COVID-19 prevention.
Local School Health Education
In addition to teaching our school community about the importance of Covid-19 prevention methods, we also reached out to two local elementary schools. We believed that it is crucial for our local community, especially kids, to understand the reasons behind wearing masks and washing hands.
For our lesson with the first graders, we came up with the analogy of the “undercover cop” and “surveillance camera” versus the “unbeatable thief” to explain the role of vaccines and test kits in combating viruses. The first graders surprised us with how much knowledge they have on COVID-19. They all understood the dangers of the virus, and thus they were able to understand our “unbeatable thief” analogy for the virus. Throughout the lesson, the first graders actively engaged in the lesson plan and asked a lot of questions regarding the virus.
Figure 20: Tiffany H.(right) and Kelly Y. (right) taught the concept of virus to a class of eager 1st graders
For our lesson with 6th graders, besides teaching the principles of viruses, we also wanted to introduce the concept of synthetic biology to them. We came up with a “candy factory” analogy in an attempt to explain the central dogma, which includes replication, transcription, and translation of DNA. Using an interactive candy-packing activity, we hope to help the students better visualize the processes of transcription and translation.
Figure 21: Ting-Yu Y. (left) and Kelly Y. (right) explaining transcription and translation
When we had another opportunity to teach 4th graders, besides just teaching them the roles of viruses and vaccines, we also explained to them the process of developing vaccines to help them gain a better understanding of what goes on behind the scenes. Through this, we introduced them to the basic concepts of central dogma. Seeing the relevance of synthetic biology in the context of COVID-19, the students were able to understand the central dogma much better.
Figure 22: Kelly Y. (left) and Ting-Yu Y. (right) taught the Central Dogma to the 4th graders at Minquan using cute figures
By the end of the lessons, the students were able to reiterate the importance of vaccines, wearing masks, and social distancing in relation to coronavirus. Using these educational interactive opportunities, we also learned more about what our community knows and doesn’t know, which helps inform our human practice approach.
Survey Trip
In order to gain a better understanding of what the public thinks regarding test kits in general, as well as make people think about the role of test kits the team decided to travel the streets of Taipei on 6/25 to acquire survey results. We did our survey trip on the day of a national holiday when students and business people would be available on the streets, which increases the diversity of our surveyed population. To get a good mix of people in terms of their socioeconomic class, age, and gender, we chose popular shopping and transit areas in Taipei as our locations for doing the survey.
In addition to asking pedestrians to help fill out our survey, we released the survey online and yielded about 2100 results. As more than 80% of our survey was done in Taiwan, we sent our survey to Team Vilnius in an attempt to diversify our survey location and population. Vilnius helped us acquire 22 responses from Vilnius, and, although the number of survey is not enough for us to do significant data comparison between countries, it was interesting for us to see how the responses done in Vilnius differed from the responses done in Taiwan.
After analyzing the survey, we summarized that the majority of our respondents would like a home test kit, which validates our approach in developing a home test kit. We further explore how to implement our project in the real world through developing a marketing plan.
Figure 23: Ting-Yu Y. (left), Ariel S. (middle), and Kelly Y. (right) ask a pedestrian to help complete our survey
Figure 24: Joyce T. (left), Tiffany H. (second to left), Matthew F. (second to right), Tsuyoshi M. (right) look for pedestrians to help complete our survey
Media Outlets
China Post
We reached out to The China Post and published an article explaining the current landscape of test kits by providing an overview of the successes and shortcomings of current detection methods. We first established that test kits are important in that they provide vital information to governments to enact policies to combat the spread of the virus. Then, we introduced and analyzed popular current methods like antigen, antibody, and molecular tests based on how the FDA classifies test kits. In the end, we elaborated on how our project can address these shortcomings and bring positive change, such as how our test kit is portable and more affordable and accurate, which are all crucial in this age of COVID-19.
ICRT
We also got interviewed by bilingual radio station ICRT, where we shared essential information about current detection methods as well as where to look for the reliable information to stay updated. The anchor further asked us to talk about our project, where we emphasized how our product is portable, affordable, and yields a colorimetric readout. Initially, Derek described how and why Viral Spiral is a significant and practical improvement upon other test kits, allowing the anchor to ask about potential applications. Wilson responded by positing a grand vision of having everyone test themselves at home with reliable instruments. Lastly, Justin also briefly explained various test kits on the market, including antibody, antigen, and molecular tests as well clarified where to look for reliable information regarding the epidemic, where he demonstrated trust in government-associated websites, like the FDA website. The recording of our interview is here (Justin's section was cut out from the final version of the radio broadcast).
News Lens International
We submitted an article to New Lens discussing the importance of at-home test kits and how they can resolve issues posed by hospital and clinic visits for receiving tests. We also elaborated that the status of at-home test kits has been further elevated during such circumstances since people are quarantined at home and public medical resources are getting depleted, both making trips to hospitals more difficult. We introduced and analyzed the pros and cons of common at-home test kits, such as the lateral flow immunoassay as well as swabbing oneself at home with a nasal swab and then sending the sample to laboratories for a PCR test. Then, we segwayed into how Viral Spiral addresses these shortcomings by combining the strengths of the two test kits mentioned above for the sake of yielding more accurate results via a less taxing process of testing.
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