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Development of a rapid test kit for SARS-CoV-2: an example of product design.
Bio-Design and Manufacturing ( IF 8.1 ) Pub Date : 2020-05-11 , DOI: 10.1007/s42242-020-00075-7
Zhanfeng Cui 1, 2, 3 , Hong Chang 1 , Hui Wang 1 , Boon Lim 2 , Chia-Chen Hsu 2, 3 , Yejiong Yu 2, 3 , Huidong Jia 1 , Yun Wang 1 , Yida Zeng 1 , Mengmeng Ji 1 , Weizhi Liu 1 , Catriona Inverarity 1 , Wei E Huang 1, 2
Affiliation  

We present an example of applying ‘need-driven’ product design principle to the development of a rapid test kit to detect SARS-COV-2 (COVID-19). The tests are intended for use in the field and, longer term, for home use. They detect whether a subject is currently infected with the virus and is infectious. The urgent need for large numbers of tests in field setting imposes constraints such as short test time and lack of access to specialist equipment, laboratories and skilled technicians to perform the test and interpret results. To meet these needs, an antigen test based on RT-LAMP with colorimetric readout was chosen. Direct use of swab sample with no RNA extraction was explored. After extensive experimental study (reported elsewhere), a rapid test kit has been fabricated to satisfy all design criteria.

中文翻译:

SARS-CoV-2 快速检测试剂盒的开发:产品设计示例。

我们展示了一个将“需求驱动”产品设计原则应用于开发快速检测试剂盒以检测 SARS-COV-2 (COVID-19) 的示例。这些测试旨在用于现场,并且长期用于家庭使用。他们检测对象当前是否感染了病毒并且具有传染性。在现场环境中对大量测试的迫切需求带来了一些限制,例如测试时间短、无法使用专业设备、实验室和熟练的技术人员来执行测试和解释结果。为了满足这些需求,我们选择了基于 RT-LAMP 的抗原检测,具有比色读数。探索了直接使用不提取 RNA 的拭子样本。经过广泛的实验研究(在别处报告),已制造出满足所有设计标准的快速测试套件。
更新日期:2020-05-11
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