Development of a rapid test kit for SARS-CoV-2: an example of product design

Zhanfeng Cui; Hong Chang; Hui Wang; Boon Lim; Chia-Chen Hsu; Yejiong Yu; Huidong Jia; Yun Wang; Yida Zeng; Mengmeng Ji; Weizhi Liu; Catriona Inverarity; Wei E Huang

doi:10.1007/s42242-020-00075-7

Development of a rapid test kit for SARS-CoV-2: an example of product design

Biodes Manuf. 2020;3(2):83-86. doi: 10.1007/s42242-020-00075-7. Epub 2020 May 11.

Authors

Zhanfeng Cui^{1

2

3}, Hong Chang¹, Hui Wang¹, Boon Lim², Chia-Chen Hsu^{2

3}, Yejiong Yu^{2

3}, Huidong Jia¹, Yun Wang¹, Yida Zeng¹, Mengmeng Ji¹, Weizhi Liu¹, Catriona Inverarity¹, Wei E Huang^{1

2}

Affiliations

¹ Oxford Suzhou Centre for Advanced Research (OSCAR), University of Oxford, Suzhou, Jiangsu People's Republic of China.
² Department of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ UK.
³ Department of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, OX3 7DQ UK.

Abstract

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.

Keywords: Antigen detection; COVID-19; Product design; RT-LAMP; Rapid test; SAR-Cov-2.