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Human Practices

Overview Gallery Understand the problem Design a good solution Implementation Back to top ⬆
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Human Practices

Plink Framework Introduction

“连接”是我们项目的核心关键词。我们希望在Plink的人类实践部分提出一个泛用的框架。我们参考了UNSW_Australia 2020和的人类实践框架和为整合人类实践设计了一套完整的框架， 包括规划、执行与展示。我们将这一套框架命名为Plink框架。在接下来的导读中，我们将介绍这一框架。

"Link" is the keyword of our project. We wanted to present a generalized framework in the human practices part of Plink. We have designed a complete framework for Integrated Human Practices, including planning, execution and demonstration. We have named this framework the Plink Framework. In the following guide, we will give an outline of the framework.

Plink Integrated Human Practices Plan and Conduction

自从项目伊始，我们就期待Plink能成为一种能在现实中发挥作用的诊断方法，并期待它作为一种合成生物学与电子技术的桥梁， 被用于更广阔的领域。这样的期望要求我们通过人类实践，找到Plink在世界上的位置，证明Plink是负责任而有价值的，并最终获得利益相关者的认可。

Since the beginning of the project, we have expected Plink to become a practical diagnostic method and to be used in a broader field as a bridge between synthetic biology and electronics. Such expectations require us to find Plink's place in the world through human practices, and to prove that Plink is responsible and valuable, and ultimately gain the recognition of stakeholders.

人类实践是我们获取信息的重要途径之一，相较于文献调研，人类实践信息是信息获取效率更高，时效性更强，更能贴近项目本身的渠道。 我们在人类实践模块的工作中充分了解了Plink与世界的关系：了解医学诊断领域的运作方式，听取不同利益相关者的意见， 并将这些意见整合到项目的全部方面。世界通过人类实践塑造了Plink。

Human practices are one of the most important ways in which we obtain information, and compared to literature research, human practices information is a more efficient, timely, and relevant channel for obtaining information about the project. Plink, as a new methodology, has a wide range of potential applications. Our work in the human practices section provides a good understanding of how Plink relates to the world: understanding how the field of medical diagnostics works, listening to the voice of different stakeholders, and integrating these views into all aspects of the project. The world shapes Plink through Human Practices.

作为一种崭新的解决方案，在人类实践中，我们接受了许多建议，并及时调整了我们的项目。随着项目发展， 我们看到了越来越多的利益相关者将Plink视为一项“有前景的”“有启发性的”工作，然而，Plink的很多方面仍然有待成熟落地。 我们收集了关于Plink在未来进一步完善的建议。我们希望Plinks有望在未来证明其价值，并真正裨益这个世界。

As a new solution, we have received many suggestions in Human Practices and have adapted our program in time. As the program has evolved, we have seen more and more stakeholders see Plink as a "promising" and "inspiring" endeavor, yet many aspects of Plink have yet to mature and implement. We have recorded suggestions on how Plink may be developed in the future. We hope that Plinks will hopefully prove their worth, and truly benefit the world.

Plink Integrated Human Practice Demonstration

在这一部分，我们将介绍我们所覆盖的利益相关者与我们希望通过人类实践彰显的价值观。

In this section, we present the stakeholders we cover along with the values we wish to manifest through our Human Practices.

理解问题是我们每一项任务的开始。在这一部分，我们将介绍我们如何了解现实世界有待改进的问题，以及我们如何描摹Plink的蓝图。

Understanding the problem is the beginning of every task we undertake. In this section, we will describe how we understand the real-world problems that need to be improved and how we propose and develop Plink.

设计一个好方案，即在理解问题的基础上，用湿实验、模型、硬件解决我们的问题。在这一部分，我们将介绍我们如何寻求为完成我们的产品寻求学界和业界的支持， 如何确定我们的技术细节，如何使我们的设计对社会有益而负责。

Designing a good solution means solving our problem with wet experiments, models, and hardware based on an understanding of the problem. In this section, we describe how we sought to enlist the support of academia and industry for the completion of our product, how we finalized our technical details, and how we made sure that our design is socially beneficial and responsible.

实施部分将讨论Plink真正面向生产和市场时所需探讨的内容与可能需要优化的内容。

The section Implementation discusses what needs to be explored and what may need to be optimized when Plink is production and marketing oriented.

Gallery

Stakeholders

Academia

学界

The academia is our supporter. Plink is involved in many specialized fields such as microbiology, design, electronics, and materials science. Academia provides us with cutting-edge information and technical support across a wide range of fields.

学界是我们的支持者。Plink涉及诸多专业领域，如微生物学、设计学、电子电路、材料学。学界为我们提供了跨领域的前沿信息与技术支持。

Non-profits & Media

非盈利性组织与媒体

Non-profits and the media are our information providers. These organizations play an important role in providing industry information and popularizing professional knowledge to the society. They provided us with a professional bird's eye view and guidance of the industry and the broader community .

非政府组织与媒体是我们的信息提供者。这些机构在提供行业信息、向社会普及专业知识方面起到了重要作用。他们在业界和更广泛的社会方面为我们提供了专业的鸟瞰与指导。

Industry

工业界

The industry，mainly similar product providers are our instructors and hypothetical competitors. Products for auxiliary diagnostics have established mature markets. The industry provided us with a vision of policies, regulations, mass production, etc., and helped the Tongji-China team to design and develop Plink.

以同类产品提供商为主的业界是我们的指导者和假想竞争者。辅助诊断产品已经建立成熟的市场。工业界为我们提供了政策法规、批量生产等方面的视野，并为Tongji-China团队设计和开发Plink提供了有力帮助。

Healthcare and diagnostic service providers

医疗与诊断服务提供者

Medical and diagnostic service providers are our hypothetical target customers. We understand the operation mode of the medical diagnostic industry chain through visits and consultations. In particular, we focus on the diagnostic capabilities and needs of primary healthcare providers.

医疗与诊断服务提供者是我们的假想目标客户。我们经由走访、咨询等了解了医疗诊断产业链的运行模式。我们尤其关注基层医疗服务单位的诊断能力及其需求。

Communities

社区

Medical and diagnostic service providers are our hypothetical target customers. We understand the operation mode of the medical diagnostic industry chain through visits and consultations. In particular, we focus on the diagnostic capabilities and needs of primary healthcare providers.

社区是我们的假想合作者。作为高度自治的居民团体，社区在争取居民权益、团结居民力量等方面起到重要作用。 社区是城市老年人的主要生活空间，在老年人之健康保障中起到关键作用。我们和社区密切沟通交流，了解体检、诊断等活动的开展情况。

Values

No Poverty

无贫困

We live in a developing country. We have explored in our human practice how communities, governments, and hospitals can work together to ensure access to healthcare resources.

我们生活在一个发展中国家。我们在人类实践中探讨了社区、政府、医院如何合作，保证医疗资源的可及性。

Reduced Inequalities

减少不平等

It is our common endeavor to work to address social equity issues so that more people's health can be better and more equitably managed.

努力解决社会公平问题，使更多人的健康得到更好的、更平等的管理，是我们共同的努力目标。

Good Health and Well-Being

健康与幸福

We learned how the current system works responsibly and effectively to safeguard the health of citizens. We explored how Plink will contribute to this system in human practices.

我们了解到现有体系如何负责任且有效地运作，以保障公民健康。我们在人类实践中探讨了Plink将如何促进这一体系。

Sustainable cities and communities

可持续的城市和社区

The concept of sustainability has taken hold in Shanghai. We explored the possibilities of Plink to address sustainability issues in the field of assisted diagnostics in human practices.

可持续理念在上海市已经深入人心。我们在人类实践中探讨了Plink解决辅助诊断领域可持续发展问题的可能性。

Understand the problem

The Story

We were exposed to and learned about the world we live in and continually examined and revised our vision and plan.

我们接触和了解了我们所生活的世界，并持续地检查和修改我们的项目愿景和计划。

We are fully aware of the current situation and and dilemma of health screening for the population. We have learned that in medical practice, it is the auxiliary diagnostic results derived from hospitals and professional organizations, etc. that are regarded as "more reliable", whereas the results obtained from the personal use of potential patients are not trusted by clinicians, and thus we believe that developing auxiliary diagnostic products for this scenario of hospitals and professional organizations is more promising. Regular physical health checkups are an important way to prevent diseases, for example, regular cancer indicator checkups are recognized as the most effective way to combat cancer, reducing the mortality rate by half.

我们在与医疗服务提供者和工业界的交流中充分了解了居民健康检查的现状和困境，并提出通过辅助诊断技术降低健康检查成本，缩短健康检查时间，提高居民体检水平。

Routine health screening is an important way to prevent diseases, for example, normalized cancer indicator screening is recognized as the most effective way to combat cancer and can reduce the mortality rate by half. At present, community health service centers (facilitied with the best medical equipment in the community) are unable to undertake the routine antibody testing programs in medical checkups, which are usually entrusted to qualified companies, with a longer testing period and additional costs like the transportation fee; and the main indicators of the routine health checkups of the residents and the door-to-door checkups of the family doctors, which have been implemented in the community, are all still confined to blood pressure and blood glucose.(hardware)

我们得知，在医学实践中，医院和专业机构等得出的辅助诊断结果才被视为"较可靠的"，而潜在患者个人使用所得的结果则不被临床医生信任，因此，我们认为，为医院和专业机构这一场景开发辅助诊断产品是更具前景的。

Antibody tests such as autoantibodies and antiphospholipid antibodies are commonly used in health screenings. For various reasons, auxiliary diagnostic techniques have not yet been widely used in health screenings. We hope that we can promote the progress of health screenings in the direction of being faster, more accessible and more equal based on the platform of the community and auxiliary diagnostic techniques.

我们和家庭医生沟通，了解了他们携带医疗器械到户为老年人检查医学指标的工作需求，和护士沟通，了解了目前较长的血液检查工作周期。目前，在社区中推行的居民常规健康普查、家庭医生上门检查的主要指标都仍限于血压、血糖；而社区中医疗检测设施最完善的社区卫生服务中心无法承担体检中常规的抗体检测项目，这些项目通常被委托于有资质的公司，检测周期较长，并有运输等附加费用。我们致力于使得我们的硬件像家庭医生的血糖仪、血压计那样便于携带，并使我们的产品能在远小于实验室检查的周期内产出初筛结果。（见hardware）

我们在与社区的活动中基本证实了合成生物学产品不会受到社会层面的抵触。我们在与非盈利性组织的交流中，在与常态化的身体健康检查是预防疾病的重要途径，例如，常态化癌症指标检查是防治癌症公认的最有效的方式，可降低一半死亡率。在健康检查中，自身抗体、抗磷脂抗体等抗体检测项目是常用的。我们了解了目前技术向基层下沉、小病在社区治疗的趋势，希望基于社区这一基层平台，借助辅助诊断技术，促进健康检查向更快捷、更易获得、更公平的方向进步。

Supplementary: Overview of the medical testing capacity of community health centers

附图：社区卫生服务中心的医学检测能力概况

Supplementary: Institutions with health screening functions

附图：承担健康检查职能的机构

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Family doctors and nurses at two Community Health Centers and Health Service Stations in Shanghai, China.

上海市的两家社区卫生服务中心、卫生服务站家庭医生与护士



Introduction

A Community Health Service Center is a primary health service provider to solve major health problems in the community and meet the demand for basic health service for the purpose of primary health service.

社区卫生服务中心是解决社区主要卫生问题、满足基本卫生服务需求为目的的基层卫生服务。

Community Health Service Center Laboratory

社区医院检验科

Chronic Disease Health Management Support Center Visual Materials at a community health center

慢性病健康管理支持中心影像资料

Child health services at a community health center

社区卫生服务中心儿童保健服务

Communication

We visited Siping Street Community Health Service Center in Yangpu District, Quyang Street Community Health Service Center in Hongkou District, and their subordinate health service stations and family doctors' workstations, etc. We visited the Chronic Disease Management Center and Laboratory Department, and had brief exchanges with nurses at the blood sampling unit and family doctors before and after working hours.

我们访问了杨浦区四平街道社区卫生服务中心、虹口区曲阳街道社区卫生服务中心，及下属的卫生服务站、家庭医生工作站等，参观了慢性病管理中心、检验科，在工作时间段前后与采血处护士、家庭医生等简短交流。

Take-home messages

We learned that the Community Health Service Centers have good medical testing facilities, the management structure of the Community Health Service Centers as the core, the subordinate health service stations and the family doctor's workstations, and the outstanding contribution of the Community Health Service Centers in safeguarding the rights and interests of women and children.

我们了解到社区卫生服务中心有较完善的医学检测设施，了解了社区卫生服务中心作为核心，下属卫生服务站和家庭医生工作站的管理结构，了解了社区卫生服务中心在保障妇女和儿童权益方面所做的卓越贡献。

We found that the Chronic Disease Management Center currently provides inefficient services, and the items that family doctors can visit households for health check-up are limited to blood pressure and blood glucose.

我们发现慢性病管理中心目前服务内容较单一，家庭医生可到户检查项目非常受限——二者均聚焦于血压、血糖。

A family doctor understood Plink's concept and thought that quick screening of some blood biochemical indicators, such as lipids and creatinine and expected us to address these issues.

家庭医生了解了Plink的构想，认为一些血液生化指标的快筛，如血脂、肌酐等是重要的，期待我们能解决这些问题。

We found that the medical testing function of health service stations was lost. There were sampling windows, blood analyzers, etc., but only retained the function of sampling and sending tests to the superior Community Health Service Center.

我们发现社区卫生服务站医学检测职能丢失，即，有采样窗口，有血常规分析仪等，但仅保留了采样并送检到上级社区卫生服务中心的职能。

We understood that the Laboratory Department of the Community Health Service Centers currently undertakes the major medical testing functions within their service area, but they do not have immunological testing capabilities.

我们了解了社区卫生服务中心的空间、人员条件能够保证免疫层析快筛试剂盒的使用是安全且专业的，了解了家庭医生到户检查医学指标，需携带便携仪器的需求，这为我们开发用户友好的硬件建立了基础。

We understood that the Laboratory Department of the Community Health Service Centers currently undertakes the major medical testing functions within their service area, but they do not have immunological testing capabilities.

We learned that the space and staffing conditions of community health centers can ensure that the use of immunochromatographic rapid screening kits is safe and professional, and that family doctors need to carry portable instruments when they visit households to check medical indicators, which established the basis for us to develop user-friendly hardware.

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Tonker Biotech Co., Ltd.

同科生物医学检验所



Introduction

Tonker Biotech is a high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents and supporting testing instruments with molecular and immunodiagnostic technologies as its core. Located in Jinzhai County, Lu'an City, Anhui Province, Tonker Biotech Medical Laboratory provides medical testing services for residents and commercial nursing homes in the county by utilizing its own molecular diagnostic reagents.

Tonker Biotech is a high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents and supporting testing instruments with molecular and immunodiagnostic technologies as its core. Located in Jinzhai County, Lu'an City, Anhui Province, Tonker Biotech Medical Laboratory provides medical testing services for residents and commercial nursing homes in the county by utilizing its own molecular diagnostic reagents.

Communication

We visited Tonker Biomedical Laboratory and spoke with a number of specialists (who requested to remain anonymous) who are involved in different areas of the company.

我们在访问了同科生物医学检验所，并与该公司多位不同领域相关负责人（要求匿名）交流。

Take-home message

We learned about the quality control requirements of industry for qualified products and the importance of standard curves and product quality control to the industry.

我们学习了工业界对合格产品的质控要求，学习了标准曲线和产品质控对于业界的重要意义。在不久后的工作中，我们使用盐溶液和商业抗体建立了曲线。（见Hardware）

We understand the intense competition within industry in the field of immunochromatography kits and the value of ingenuity.

我们了解了社区与医学检验所的合作模式，并了解了化学发光法等更被临床认可的技术。

We have learned that immunochromatography kits, especially those for personal use, are not well established in clinical practice.

我们了解到工业界在免疫层析试剂盒领域内的激烈竞争，以及独创性的重要价值。

我们了解到免疫层析试剂盒，尤其是供个人使用的免疫层析试剂盒，在临床实践中的地位不高。

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Ms. Xie, president of a community residents' committee on Siping Block, Shanghai

上海市四平路街道某社区居民委员会主任谢女士



Introduction

The residents' committees is a primary mass self-government organization. Ms. Xie, an elderly resident of a community on Siping Road Street, is enthusiastic about community building and volunteer services and was elected as the President of the Residents' Committee.

居民委员会是基层群众性自治组织。谢女士是四平路街道某社区老年居民，热心参与社区建设与志愿服务，被选举为社区居民委员会主任。

Communication

We met Ms. Xie at the Community Neighborhood Center where she was working as a volunteer to prepare a free family education seminar. Ms. Xie introduced us to the model of cooperation between the Residents' Committee and the People's Government's street office in the medical field, and the free health screening service provided by the Community Health Service Center to the residents. We discussed the aspiration of Plink.

我们在社区睦邻中心见到了正在作为志愿者准备一场免费家庭教育讲座的谢女士。谢女士向我们介绍了居民委员会与人民政府街道办事处在医疗领域的合作模式，以及社区卫生服务中心为居民提供免费健康筛查服务的情况。我们谈论了Plink的愿景。

Take-home message

With the concerted efforts of many parties, the health welfare of residents has been promoted and safeguarded.

在多方共同努力下，居民的健康福利得到了促进和保障。

Residents maintain expectations for more universal and convenient health screenings.

居民对更普及、更便捷的健康检查保持期待。

In terms of applications of synthetic biology, residents welcome innovative programs that have a positive effect on the community.

就合成生物学的应用而言，居民欢迎对社区起到积极作用的创新项目。

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Questionnaire survey on participation in medical check-ups

关于体检参与度的问卷调查



Introduction

In order to obtain first-hand information on the participation of community residents in health checkups, a questionnaire survey on participation in health checkups was conducted by distributing questionnaires.

为获得社区居民的健康体检参与度的第一手信息，我们通过发放问卷进行了关于体检参与度的问卷调查。

Communication

The questionnaire, from which we obtained information on health check participation from college students (mostly aged 18-24) and some community residents (ranging in age from 25 to over 80, with a predominance of aged 51-70), was a way for us to get a first-hand understanding of local issues and the views of our clients, although it was not sufficiently wide-ranging due to the constraints of the questionnaire.

我们从问卷中获得了学校学生（大多数年龄为18至24岁）和一些社区居民（年龄范围涵盖从25岁到80岁以上，且以51岁至70岁为主）的体检参与度情况，尽管由于条件限制这个问卷的人群涵盖不够广泛，但它是我们亲身了解当地问题和服务对象想法的渠道。

Take-home message

We realize that the majority of the participants agree with the statement " I should receive medical checkups more regularly", and most of them receive medical checkups at a reasonable frequency upon the request, suggestion or organization of their schools, units, communities or street offices.

我们认识到绝大多数受调研对象认同“应该较定期地接受体检”这一表述，且大部分在学校、单位、社区、街道办等要求、建议或组织下，以较合理的频率接受健康检查。

We realize that the medical examination centers of hospitals at all levels, especially those of tertiary or secondary hospitals, are the places where most of the participants receive health checkups, and most of the participants receive laboratory tests such as urine routine and blood routine during their medical checkups. More than half of the participants were able to obtain the report within 7 days, but some participants still obtained the report after a longer period of time.

我们认识到各级医院，尤其是三级或二级医院的体检中心是大多数受调研对象接受健康检查的场所，且大多数受调研对象在接受体检时接受了尿常规、血常规等实验室检查。超过半数受调研对象在7天内能获取报告，但仍然有一部分受调研对象在较长的时间后才获得报告。

We recognized that the cost of medical checkups for some of the participants was not cheap for the local standard of living and could deepen health inequalities.

我们认识到一部分受调研对象体检的费用对于本地生活水平而言并不算便宜，并可能加深健康上的不平等。

We collected residents' concerns about health issues where antibody testing is needed for inflammation, cancer, and multiple infectious diseases.

我们收集了居民对健康问题的担忧，其中，对炎症、癌症、多种传染性疾病的检测都需要抗体检测。

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Mr. Yapeng Jia, Officer of Society of Quality Administration of Health Service Institutions, Chinese Health Association

中国健康管理协会 健康服务机构质量管理分会 负责人贾亚朋先生



Introduction

The Chinese Health Association is an association in the field of health management initiated by a number of famous hospitals, jointly applied by enterprises and institutions, and approved by the State Council. The Quality Management Branch of Health Service Organization of Chinese Health Association is a second-level branch under the leadership of Chinese Health Association, which is a professional, non-profit, academic national second-level social organization voluntarily formed by the personnel engaged in the management of health undertakings, the management of medical institutions, the health service organizations, and professional third-party authoritative assessment organizations.

中国健康管理协会是由多家著名医院发起，联合企业事业单位共同申请，经国务院批准成立的健康管理领域协会。中国健康管理协会健康服务机构质量管理分会是在中国健康管理协会领导下的二级分支机构，主要由从事卫生事业管理、医疗机构管理、健康服务机构，专业第三方权威评测机构等工作的人员自愿组成的专业性、非营利性、学术性的全国性二级社会团体。

Communication

We interviewed Mr. Jia remotely via instant messaging software. We discussed the role of primary hospitals in health management, the significance and difficulty of extending testing technology to the communities, and the important value of immunoscreening in areas such as cancer prevention and treatment.

我们通过即时通讯软件远程采访了贾亚朋先生。我们探讨了基层医院在健康管理中的角色，检测技术下沉的意义和困难性，以及免疫筛查在癌症防治等领域的重要价值。

Take-home message

Mr. Jia told us that early detection, diagnosis and treatment is the most effective way to fight cancer and "can reduce the mortality rate by half".

贾先生告诉我们，早发现、早诊断、早治疗是对抗癌症最有效的方式，“可以降低一半死亡率”。

Mr. Jia told us that at present, the institutions that undertake health screening are mainly medical checkup centers in hospitals, but he is optimistic about the rollout of Plink in the community amidst the general trend of sinking technology and functions.

贾先生告诉我们，目前承担健康检查的机构主要是医院的体检中心，但目前存在技术普遍下沉、小病在社区治疗的趋势，因此他对Plink在社区的推广表示乐观。

Mr. Jia suggested that we should take increasing the population screening rate and increasing the early tumor detection rate as the short-term goal of screening, and promote it in the direction of primary screening (population stratification) and fine screening (high-risk groups). We accepted this proposed niche of Plink.

贾先生建议我们以提高人群筛查率和提高早期肿瘤检出率作为筛查短期目标，从初筛（人群分层）、精筛（高危人群）方向推广。我们接受了这一项目定位。

Design a good solution

Summary

With the combined support and help of many forces, we continued to make adjustments and revisions to finalize our project.

在多种力量的共同支持和帮助下，我们不断调整修正，最终完成了我们的项目。

We learned about the antibody rapid assay products already available on the market, and we learned about the frontier of point-of-care testing (POCT) technology development. We studied the Regulations for Supervision and Administration of Medical Devices and other laws and regulations to ensure that our project was responsible.

我们了解了市面上已有的抗体快筛检测产品，并了解了现场快速检验（point-of-care testing, POCT）技术的前沿。我们学习了《医疗器械监督管理条例》等法律法规，确保我们的项目是负责任的。

We interacted with industry and academia, and with their advice and help we established our experimental system (see Wet lab), hardware design (see Hardware), and so on.

我们与业界、学界交流，在他们的帮助下建立了我们的实验体系（见 Wet lab）、硬件设计（ Hardware）等。

We explored the promise of e-pili for applications. With the help of multiple forces, we established techniques to modify, produce, and isolate pili, and built portable hardware to detect antibodies basically by measuring the change in conductivity of the detection element before and after sample addition. (see Design)

我们探索了导电菌毛在应用领域的前景。我们在多方力量的帮助下建立了改造、生产并分离菌毛的技术，并制备小型化的硬件，通过测量样品添加前后检测元件的电导率变化来检测抗体。（见 Design）

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Tonker Biotech Co., Ltd.

同科生物诊断试剂产品化中心



Introduction

The Diagnostic Reagent Productization Center of Tonker Biotech is located in Jinzhai County, Lu'an City, Anhui Province, which undertakes the production and quality inspection of molecular diagnostic reagents, chemiluminescent reagents and other products.

同科生物诊断试剂产品化中心位于安徽省六安市金寨县，承担分子诊断试剂、化学发光试剂等产品的生产和质检工作。

Communication

We were allowed to visit the whole assembly line under the coordination of Dr. Wang Yanfang and others from Tongji University and Dr. Zhang Jie and others from Tonker Biotech. We had closed-door meetings with three senior managers (requesting anonymity), and they carefully understood our technological vision. We learned about laws and regulations, got to know the ideas of the industry, and gained personal opinions about our innovation.

在同济大学汪燕芳博士等和同科生物张杰博士等的协调下，我们被获准参观全部流水线。我们先后与三位高级管理（要求匿名）进行了闭门会谈，相关负责人认真了解了我们的技术设想。我们在此学习了法律法规，了解了工业界的想法，并获得了关于创新的个人意见。 Eng:

Take-home message

We have studied the Regulations on the Supervision and Administration of Medical Devices issued by the State Council, the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents issued by the State Drug Administration, and other laws and regulations. We learned that these laws and regulations maintain a high frequency of updates, keep pace with the level of technological development and its future trends, and are synthetic biology friendly. With reference to these documents, we have designed Plink consumables to ensure that the hardware does not come into direct contact with the pathogenic samples under the premise of proper operation, and have conceived a quality control idea to replace the quality control line in the traditional immunochromatography kit .

我们学习了国务院发布的《医疗器械监督管理条例》、国家药品监督管理局发布的《医疗器械注册备案管理办法》、《体外诊断试剂注册备案管理办法》等法律法规。我们了解到这些法律法规保持较高频率的更新，与技术发展水平及其未来发展趋势保持同步，并且是对合成生物学友好的。我们参考这些文件，设计了Plink耗材，确保在正确操作的前提下，电路与病原样本不接触、并构思了替代传统免疫层析试剂盒质控线的质控思路。

We explored the market for medical testing products, and future trends in the field. We also learned about the current problems of existing technologies, such as colloidal gold, latex microspheres, fluorescence immunochromatography and all three technical routes have a rough idea of quality control, which has brought about confusing and atypical test results repeatedly reported, such as false positives caused by embedded line coloring, and contamination of the window by non-specific fluorescent substances. In addition, kit components such as latex microspheres and colloidal gold based on heavy metal chemicals, petrochemicals, etc. are difficult to meet the requirements of sustainable development.

我们探讨了医学检测产品的市场、该领域的未来发展趋势。我们也了解了已有技术目前存在的问题，如胶体金法、乳胶微球法、荧光免疫层析法等全部三种技术路线的质控思路都较粗糙，由此带来了屡见于报道的令人困惑的非典型测试结果，如包埋线显色假阳性、非特异性荧光物质污染视窗等。另外，基于重金属化工、石油化工等的乳胶微球、胶体金等试剂盒组分都难以满足可持续发展要求。

We were cautioned that the market may be conservative towards products that are methodologically innovative, given that many of the technologies are already more mature.

我们被告诫，在许多技术已经较成熟的前提下，市场可能对在方法学上创新的产品持保守态度。

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Dr. Jie Shen, head of Sanqi Biotech infectious disease diagnostic reagent R&D platform

三奇拜克 诊断试剂研发平台负责人 沈杰博士



Introduction

Sanqi BioTech infectious disease diagnostic reagent R&D platform is committed to carrying out research on diagnostic reagents and diagnostic instruments, and has achieved a number of domestic cutting-edge and certain international influence of the original innovation results in the innovative research and development of diagnostic reagents.

三奇生物传染性疾病诊断试剂研发平台平台致力于开展诊断试剂及诊断仪器的研究，在诊断试剂的创新研发中取得了一批国内前沿并具有一定的国际影响力的原始创新成果。

Communication

Under the coordination of Dr. Ye Leng from Tongji University, we were allowed to visit Sanqi BioTech and communicate with Dr. Jie Shen on technology and industry related issues. Here we learned about the classification and technical standards of lateral flow immunochromatographic assays and gained insight into industry dynamics. We learned the preparation technology of chromatography strips here.

在同济大学冷晔博士协调下，我们被获准参观三奇拜克公司，并与沈杰博士交流技术和产业相关问题。我们在此了解到侧流免疫层析测定的分类和技术标准，并深入了解了行业动态。我们在此学习了层析试剂条的制备技术。

Take-home message

Dr. Shen understood our project design and introduced us to immunofluorescence chromatography fast screening kits with similarities.

沈博士了解了我们的项目设计，并向我们介绍了有相似之处的免疫荧光层析快筛试剂盒。

Dr. Shen introduced us systematically to the classification and technical standards of lateral flow immunochromatographic assays, and the current trens of the industry.

沈博士向我们系统介绍了侧流免疫层析测定的分类和技术标准，和当前行业发展状况。

Dr. Shen introduced the design idea of the structure of the chromatography reagent strip, showed us the preparation process of the chromatography reagent strip, and introduced the important equipment.

沈博士向我们介绍了层析试剂条结构的设计思路，带我们参观了层析试剂条的制备过程，并介绍了重要的设备。

Dr. Shen gave us an antigen detection reagent strip and a piece of nitrocellulose membrane as a reference for hardware design.

沈博士赠与我们一份抗原检测试剂条，及一片硝酸纤维素膜作为硬件设计的参考。

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Dr. Jun Yao, University of Massachusetts Amherst

马萨诸塞州立大学阿姆赫斯特分校 Jun Yao博士



Introduction

Dr. Yao, University of Massachusetts Amherst, is an expert in conducting nanowires and their applications, and our project was inspired by a paper he published as a corresponding author. In collaboration with Prof. Derek Lovley and others, he has done pioneering and outstanding work in the field of basic and applied research on conductive nanowires. The study of conducting nanowires opens up new ideas in synthetic biology.

马萨诸塞州立大学阿姆赫斯特分校Yao博士是导电纳米线及其应用领域的专家，我们的项目灵感即来源于他作为通讯作者发表的一篇论文。他和Derek Lovley教授等合作，在导电纳米线的基础和应用研究领域做出了首创性的杰出的工作。导电纳米线的研究打开了合成生物学的新思路。

Communication

Dr. Yao was our first source of information about the Geobacter sp. During the early stages of the project, we emailed Dr. Yao several times to ask him questions about the project, and due to the lack of physics background, we misjudged the nature of the hair material. Due to the lack of physics background, we had misjudged the nature of the pili material, and Dr. Yao's design of conductive pili for sensors inspired us to finalize our solution, and Dr. Yao provided us with physics guidance for our project.

Yao博士是我们了解金属还原地杆菌的第一消息来源。在项目早期调研中，我们多次向Yao博士发邮件请教项目相关问题。由于缺少物理学背景，我们对菌毛材料的性质存在误判。Yao博士将导电菌毛用于传感器的设计为我们最终确定解决方案提供了灵感。Yao博士为我们的项目提供了物理学方面的指导。

Take-home message

Dr. Yao introduced us to the correlation between the concepts of conductivity, voltage, and performance evaluation of bacterial pili films, which disproved our previous hypothesis-based project design.

Yao博士向我们介绍了菌毛薄膜电导率、电压、性能评价等概念的关联，这推翻了我们之前基于假设的项目设计。

Dr. Yao introduced us to his group's new research direction on conductive bacterial pili, which provided significant inspiration for our detection element design. We finally decided to develop a diagnostic approach using the "e-pili".

Yao博士向我们介绍了其课题组在导电菌毛方面的新研究方向，即传感器，这为我们的检测元件设计提供了重要启发。我们最终决定利用导电菌毛开发一种诊断技术。

After consulting with Dr. Yao, we made adjustments to the project design. We modeled the problem of optimizing the pilus protein structure to increase pili conductivity based on the more accepted theory in the current academic community and considering the benefits that can be gained from an increase in pili conductivity in the circuits.

咨询Yao博士后，我们对项目设计进行了调整。我们基于目前学界较认可的学说，并考虑电路中菌毛电导率的提高所能带来的好处，就优化菌毛单体结构以提高菌毛电导率问题进行了建模。

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Prof. Changsheng Du, College of Life Science and Technology, Tongji University

同济大学生命科学与技术学院 杜昌升教授



Introduction

Prof. Changsheng Du is a Principal Investigator at the School of Life Sciences and Technology, Tongji University. He has made outstanding achievements in the field of molecular immunity and signal transduction research.

杜昌升教授是同济大学生命科学与技术学院的一位首席研究员。他在分子免疫和信号转导研究领域做出了杰出成就。

Communication

We initially wanted to use E. coli as a chassis organism. Prof. Du checked our project plan and suggested that too large a plasmid might make the transformation experiment unsuccessful. We eventually modified our original plan.

我们最初希望使用大肠杆菌作为底盘生物。杜教授帮助我们检查了我们的项目计划，并提出太大的质粒可能使得转化实验不成功。我们最终修改了原计划。

Take-home message

Prof. Du pointed out some problems in our experiment plan and helped us to modify and improve the plan.

杜老师指出了我们的实验计划中一些问题，并帮助我们修改和完善计划。

Regarding the plasmid design, we discussed the option of co-transformation and the option of switching to other chassis organisms, and finally chose the latter.

就质粒设计问题，我们讨论了共转化的方案，及换用其他底盘生物的方案，并最终选择了后者

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Dr. Jiahao Shi, College of Life Science and Technology, Tongji University

石同济大学生命科学与技术学院石嘉豪博士



Brief Introduction

Dr. Jiahao Shi is a senior lab technician at Tongji University.

石嘉豪博士是一位同济大学资深实验员。

Communication

Vibrio natriegens is an expression system that is not commonly used at Tongji University, and we have never been able to obtain a commercialized Vibrio natriegens expression system. We had to use V. natriegens ATCC 14048. Tongji-China was unable to successfully transform the plasmid into ATCC 14048 using chemical transformation for a long time. After a long time of unsuccessful attempts, we approached Dr. Shi for help.

需钠弧菌是一种在同济大学不常用的表达系统，而我们始终没能获得商品化的一种需钠弧菌表达系统。我们不得不选用需钠弧菌ATCC 14048。 Tongji-China在很长一段时间里无法利用化学转化方法成功将质粒转入ATCC 14048中。在长时间尝试无果后，我们找到了石博士以寻求帮助。

Take-home message

Dr. Shi helped us explore a new transformation option, the electrotransformation option.

石博士帮助我们探索了新的转化方案，即电转化方案。

Dr. Shi lent us a MicroPulser for our use.

石博士将电转化仪借给我们使用。

After a period of time, we succeeded in obtaining a stable electrotransformation protocol.

在一段时间后，我们成功获得了稳定的电转化方案。

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Saverio Silli, Course Director of Fablab O Shanghai

Fablab O Shanghai主任 Saverio Silli



Introduction

Fablab Shanghai is the first Fab Lab in mainland China of the global Fablab network centered on MIT Labs, U.S.A. Saverio Silli is an active member of the maker community, director of Fablab O Shanghai, and organizes Digital Fabrication workshops in Rome, Milan, Paris, Seoul, Shenzhen, Xi'an, Boston, and other locations.

Fablab Shanghai is the first Fab Lab in mainland China of the global Fablab network centered on MIT Labs, U.S.A. Saverio Silli is an active member of the maker community, director of Fablab O Shanghai, and organizes Digital Fabrication workshops in Rome, Milan, Paris, Seoul, Shenzhen, Xi'an, Boston, and other locations.

Communication

We explored with Saverio Silli the possibilities of further reducing the carbon footprint of our hardware, Plinker. We were guided to make more environmentally friendly carbon-based electrode sheets.

我们和Saverio Silli探讨了进一步降低我们的硬件Plinker碳足迹的可能性。我们在指导下制作了更加环境友好的碳基电极片。

FabLab helped us continuously to build our hardware prototypes by providing space, equipment and tools.

FabLab在空间、设备和工具方面为我们构建硬件原型提供了持续的帮助。

Take-home message

FabLab provided space, equipment and tools to us to build the hardware.

FabLab在构建硬件所需的空间、设备和工具方面为我们提供了帮助。

Based on our concern for sustainable development goals, we made an attempt to use electrodes based on biodegradable materials.

基于对可持续发展目标的关注，我们做了基于可降解材料电极的尝试。

We realized that applying biodegradable electrodes to our hardware was technically difficult and could lead to unnecessary cost increases. After discussion, we finally discontinued the attempt.

我们在尝试过程中发现将可降解材料电极应用到我们的硬件上的技术难度大，且可导致不必要的成本增加。经过探讨，我们最终中止了这一尝试。

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Researcher Zhanyun Guo, Institute of Protein Research, College of Life Science and Technology, Tongji University, China

同济大学生命科学与技术学院蛋白质研究所郭占云研究员



Introduction

Dr. Zhanyun Guo is a senior researcher at the Institute of Protein Research. He is engaged in protein peptide hormone research, G protein-coupled receptor (GPCR) interaction research, and plant protein ligase research.

郭占云博士是蛋白质研究所的资深研究员。从事蛋白质多肽激素研究、G蛋白偶联受体（GPCR）相互作用研究、植物蛋白连接酶研究等工作。

Communication

For a long time, Tongji-China has encountered difficulties in areas such as protein expression and purification. Prof. Guo guided and helped us with these technical issues.

在很长一段时间里，Tongji-China在蛋白质表达和纯化等方面遇到困难。郭教授在这些技术上为我们提供了指导和帮助。

Take-home message

We have maintained close communication with Prof. Guo after we contacted him.

我们在联系上郭教授之后，与他保持了密切的沟通。

Prof. Guo provided suggestions on establishing transformation and protein expression protocols.

郭教授在质粒转化、蛋白质表达等技术上提供了建议。

Prof. Guo gifted us an E. coli BL21 strain for backup.

郭教授赠与我们大肠杆菌BL21菌株备用。

Prof. Guo provided us with a sample of protein with His tag as a positive control.

郭教授为我们提供了带有His tag的阳性品，作为对照。

Implementation

Summary

Plink, as a new methodology, has a wide range of potential applications. Currently, there are many mature antibody fast-screening assay products on the market, such as colloidal gold, latex microsphere, fluorescence immunochromatography, etc. As mentioned earlier, this does not mean that the field is perfect and Plink is still expected to make a difference to society in this market.

Plink作为一种新的方法学，其潜在的应用领域是广泛的。目前，市面上已有较多成熟的抗体快筛检测技术路线，如胶体金法、乳胶微球法、荧光免疫层析法等。如前文所述，这不意味着这一领域已臻完美，Plink仍有望在这个市场中为社会带来改变。

Many stakeholders in hospitals and industry mentioned that auxiliary diagnostic technologies are not yet widely used in health screening for a variety of reasons. Some of these reasons are technical issues and some are regulatory issues. Technical issues, such as lack of sensitivity and specificity, are central, while managerial "mistrust" of multiple auxiliary diagnostic technologies is secondary.

许多医院和工业界的利益相关者都提及，由于各种原因，辅助诊断技术尚未在健康检查中广泛应用。这些原因中，一些是技术问题，一些是管理问题。其中，技术问题，如灵敏度和特异度不足，是核心的问题，而管理上对多种辅助诊断技术的“不信任”则是继发性的。

The design of Plink is unlike any previous immunochromatographic kit in that its bio-producible, degradable properties of the core components and the fact that it requires only basic electrical instrumentation have the potential to be exploited and will hopefully provide a responsible and new direction for auxiliary diagnostic techniques.

Plink的设计不同于以往任何一种免疫层析试剂盒，菌毛可生物生产、可降解的属性和仅需基本电学仪器的属性具有开发利用的潜能，希望能为辅助诊断技术提供一种负责任的、新的方向。

In this section, we demonstrate the issues that may need to be discussed and addressed in the future of our project, as well as the social value of this project.

在这一部分，我们展示了我们的项目未来可能需要讨论和解决的问题，以及这个项目的社会价值。

Dr. Jie Shen , head of Sanqi Biotech infectious disease diagnostic reagent R&D platform

三奇拜克 诊断试剂研发平台负责人 沈杰博士

Abstract

In the course of maintaining communication with Dr. Jie Shen, Dr. Shen proposed another option for us, i.e., to chemically modify the antibody with conductive pili to make it function like chemically labeled antibodies, and to use the more traditional strip design of the double antibody sandwich method. Considering the risks associated with this option, e.g. poor mobility of pili in chromatography, and the high cost of trial and error for us, we did not adopt this design. Whether this option can be realized remains to be demonstrated and tested in the future.

在与沈杰博士保持交流的过程中，沈博士为我们提出了另一种方案，即将导电菌毛化学修饰抗体，使其发挥类似化学标记抗体的功能，并采用较传统的双抗体夹心法的试剂条设计。考虑到这个方案存在菌毛流动性不佳等风险，而我们试错成本过高，我们没有采纳这个设计。这一方案能否实现仍有待未来论证和检验。

Take-home message

We understand that the architecture and production model of the double antibody sandwich method is well established.Dr. Shen offered to provide support on equipment, but we learned that the pili may not be compatible with existing membrane scribing equipment.We explored the question of whether the nature of the pili was sufficient to allow for chromatographic flow across the membrane. After a team discussion, we shelved this option.

我们了解到双抗体夹心法的架构和生产模式都是已经成熟的。沈博士表示愿意提供设备上的支持，但我们了解到菌毛可能与现有划膜设备不兼容。我们探讨了菌毛的性质是否足以使其在膜上层析流动的问题。经过队内讨论，我们搁置了这一方案。

Dr. Shen introduced us to the development and sales of fluorescent microsphere immunochromatography kits and accompanying assay instruments. We learned that the supporting instruments are expensive for buyers, and the cost of the instruments can only be offset by purchasing the kits in large quantities, which limits the possibility of expanding the market for this technology route.

沈博士向我们介绍了荧光微球法免疫层析试剂盒与配套测定仪器的研发和销售情况。我们了解到配套测定仪器对于购买者来说是昂贵的，大批量采购试剂盒才能折抵仪器成本，这限制了这一技术路线拓展的可能性。

Associate Prof. Ang Li, College of Life Science and Technology, Tongji University, China

同济大学生命科学与技术学院 李昂副教授

Abstract

As we approach the concluding phase of our project, we would like to discuss our project with experts in the field of immunology in order to draw lessons learned and to understand the future potential of the project.

在项目接近尾声的总结阶段，我们希望与免疫学领域的专家讨论我们的项目，以总结经验并了解项目未来的潜力。

Take-home message

We again reviewed the critical nature of the problem our project addresses and received positive feedback from Dr. Li.

我们再次回顾了我们的项目所解决的问题的关键性，并获得了李博士的肯定

Dr. Li suggested to us the importance of antibody detection in infectious diseases, which further broadened our perspective.

李博士向我们提出了抗体检测在感染性疾病中的重要意义，这进一步拓宽了我们的视野。

Introduction

Dr. Li has been engaged in research on tumor immunity and tumor vaccine development.

李昂博士从事肿瘤免疫和肿瘤疫苗开发方面的研究。

Sailing Heath

健识局

Introduction

Sailing Heath is a medical and health field information self-media, the platform mainly focuses on the field of health care, providing medical policy interpretation, industry trend analysis, industry observation and other aspects of the content..

健识局是一个医疗健康领域资讯自媒体，该平台主要关注医疗健康领域，提供医疗政策解读、行业趋势分析、产业观察等多方面的内容。

Abstract

We contacted the Head of Operations at the Sailing Health (who requested to remain anonymous) . We exchanged opinions about the societal impact and outlook of immuno-fast screening kits. We obtained several published reports from Sailing Health that cover a wide range of fast screening methods and application scenarios as a reference. This provided a shortcut to understanding the impact of technology on society.

我们与健识局运营负责人（要求匿名）取得了联系。我们交流了关于免疫快筛试剂盒社会影响和前景的意见。我们获取了健识局的数篇涵盖了多种快筛方法、多种应用场景的已发表报道作为参考。这为我们了解技术对社会的影响提供了捷径。

Take-home message

We learned that multiple related concepts of fast screening tests for disease are gaining societal attention.

我们了解到快筛检测疾病的多个相关的概念正在获得社会关注。

We learned that the relationship between rapid screening tests and society is complex.

我们了解到快筛检测方法与社会的关系是复杂的。

Our discussion touches on the misty position of rapid screening tests as auxiliary diagnostic technologies - where cost and time reductions often come at the cost of decreasing clinical metrics such as sensitivity and specificity. This diviation from the gold standard has left the status of auxiliary diagnostics in clinical diagnostics and public health management unclear. This complex issue remains to be explored.

我们的讨论涉及了作为辅助诊断技术的快筛检测方法的尴尬地位——在这些技术中，成本之降低和时间之缩短通常是以灵敏性和特异性等临床指标的下降为代价的。与金标准的差异这使得辅助诊断技术在临床诊断和公共卫生管理领域地位不明确。这一复杂问题仍然有待探讨。