COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles

被引:22
作者
Ghaffari, Abdi [1 ,2 ]
Meurant, Robyn [3 ]
Ardakani, Ali [2 ]
机构
[1] Queens Univ, Dept Pathol & Mol Med, Kingston, ON K7L 3N6, Canada
[2] Novateur Ventures Inc, Vancouver, BC V6E 3P3, Canada
[3] NSF Hlth Sci, York YO62 6AF, N Yorkshire, England
关键词
COVID-19; point-of-care diagnostic test; target product profile; clinical performance; SARS-COV-2;
D O I
10.3390/diagnostics11010115
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
COVID-19 pandemic will continue to pose a major public health threat until vaccination-mediated herd immunity is achieved. Most projections predict vaccines will reach a large subset of the population late in 2021 or early 2022. In the meantime, countries are exploring options to remove strict lockdown measures and allow society and the economy to return to normal function. One possibility is to expand on existing COVID-19 testing strategies by including large-scale rapid point-of-care diagnostic tests (POCTs). Currently, there is significant variability in performance and features of available POCTs, making selection and procurement of an appropriate test for specific use case difficult. In this review, we have used the World Health Organization's (WHO) recently published target product profiles (TPPs) for specific use cases of COVID-19 diagnostic tests to screen for top-performing POCTs on the market. Several POCTs, based on clinical sensitivity/specificity, the limit of detection, and time to results, which meet WHO TPP criteria for direct detection of SARS-CoV-2 (acute infection) or indirect diagnosis of past infection (host antibodies), are highlighted here.
引用
收藏
页数:12
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