Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration
Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration
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针对资源匮乏环境的 COVID-19 快速诊断的快速开发：通过透明度、响应能力和开放协作加速交付
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
S. Krishna
中科院分区：
文献类型：
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作者：
E. Adams;Y. Augustin;R. Byrne;D. Clark;M. Cocozza;A. Cubas;L. Cuevas;M. Cusinato;B. Davies;Mark Davis;P. Davis;A. Duvoix;N. Eckersley;T. Edwards;T. Fletcher;A. Fraser;G. Garrod;L. Hadcocks;Q. Hu;Michael Johnson;G. A. Kay;Katherine Keymer;D. Kirwan;K. Klekotko;Z. Lewis;J. Mason;J. Mensah;S. Menzies;I. Monahan;C. Moore;G. Nebe;S. Owen;T. Planche;C. Sainter;J. Schouten;H. Staines;L. Turtle;C. Williams;J. Wilkins;K. Woolston;A. Sall;J. Fitchett;S. Krishna
今年1月，Mologic开始了针对COVID-19诊断的产品开发途径，重点是ELISA和快速诊断测试（RDTs），预计将获得Wellcome Trust和DFID的资助。使用Mologics IgG ELISA对来自已知COVID-19患者和医院阴性对照的755份临床样本进行了检测。191例SGUL前瞻性入组患者报告的诊断后第7天或更长时间的敏感性为95%，诊断后第10天或更长时间的敏感性为97%。对2019年12月前的564份样本进行了特异性检测，包括最常见的呼吸道病原体、其他类型的冠状病毒和黄病毒。该面板的特异性为97%。这是Mologic针对COVID-19的一系列产品中的第一款，将用于COVID-19诊断、接触者追踪和血清流行病学研究，以估计疾病负担和传播，重点是确保最低资源环境的可获得性、可负担性和可用性。
In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and hospital negative controls were tested on Mologics IgG ELISA. The reported sensitivity on 191 SGUL prospectively enrolled patients was 95% on day 7 or more post diagnosis, and 97% 10 days or more post-diagnosis. A specificity panel comprising 564 samples pre-December 2019 were tested to include most common respiratory pathogens, other types of coronavirus, and flaviviruses. Specificity in this panel was 97%. This is the first in a series of Mologic products for COVID-19, which will be deployed for COVID-19 diagnosis, contact tracing and sero-epidemiological studies to estimate disease burden and transmission with a focus on ensuring access, affordability, and availability to lowest resource settings.