SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity.
SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity.
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DOI：
10.1016/j.medj.2020.12.010
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发表时间：
2021-03-12
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影响因子：
--
通讯作者：
Grubaugh ND
中科院分区：
文献类型：
--
作者：
Vogels CBF;Watkins AE;Harden CA;Brackney DE;Shafer J;Wang J;Caraballo C;Kalinich CC;Ott IM;Fauver JR;Kudo E;Lu P;Venkataraman A;Tokuyama M;Moore AJ;Muenker MC;Casanovas-Massana A;Fournier J;Bermejo S;Campbell M;Datta R;Nelson A;Yale IMPACT Research Team;Dela Cruz CS;Ko AI;Iwasaki A;Krumholz HM;Matheus JD;Hui P;Liu C;Farhadian SF;Sikka R;Wyllie AL;Grubaugh ND
扩大SARS-CoV-2检测以满足安全重新开放的需求继续受到检测成本和供应链短缺的困扰。作为回应，我们开发了SalivaDirect，并获得了美国食品药品监督管理局（FDA）的紧急使用授权（EUA）。我们简化了基于唾液的诊断测试，通过（1）不需要带有防腐剂的采集管，（2）用简单的酶促和加热步骤取代核酸提取，以及（3）用双重qRT-PCR检测试剂盒检测标本。此外，我们使用多家供应商的试剂和仪器验证了SalivaDirect，以最大限度地减少供应链问题。从我们的医院队列中，我们显示出用SalivaDirect检测的唾液和用商业qRT-PCR试剂盒检测的鼻咽拭子之间的高阳性一致性（94%）。我们与美国国家篮球协会（NBA）和国家篮球运动员协会（NBPA）合作，测试了来自健康个体的3，779份唾液样本，并检测出低无效率（0.3%）和假阳性率（<0.05%）结果。我们证明，唾液是SARS-CoV-2筛查拭子的有效替代品，并且SalivaDirect可以使大规模检测变得更加容易和负担得起。独特的是，我们可以指定其他实验室使用我们EUA下的敏感，灵活和简化的平台（https：//publichealth.yale.edu/salivadirect/）。这项研究由NBA和NBPA（N.D.G.）资助，霍夫曼家族捐赠者建议基金（N.D.G.），来自乔治梅森大学（N.D.G.）莫卡特斯中心的新兴风险投资公司的快速资助，耶鲁全球健康研究所（N.D.G.），Beatrice Kleinberg Neutruth基金（A.I.K.）C. B. F. V.由NWO Rubicon 019.181EN.004支持。频繁的检测对限制SARS-CoV-2传播至关重要。为了满足这一需求，我们开发了SalivaDirect，这是一种灵敏、简化和灵活的测试框架，已获得美国食品药品监督管理局（FDA）的紧急使用授权（EUA）。我们测试了从医院队列中收集的唾液，与用商业诊断试剂盒测试的成对鼻咽拭子相比，显示出较高的阳性一致性（94%）。然后，我们与美国国家篮球协会（NBA）合作，测试了一个大的健康人群队列，发现无效率（0.3%）和假阳性率（0.03%-0.05%）很低。我们的研究表明，SalivaDirect可以通过提供一个负担得起的框架来帮助提高测试能力，该框架不太容易出现供应链短缺。SalivaDirect是一种敏感的基于唾液的COVID-19诊断测试，已获得美国FDA的紧急使用授权。由于能够指定其他实验室，灵活和简化的框架有助于提高现有实验室基础设施的SARS-CoV-2检测能力。
Scaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). We simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues. From our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasopharyngeal swabs tested with a commercial qRT-PCR kit. In partnership with the National Basketball Association (NBA) and National Basketball Players Association (NBPA), we tested 3,779 saliva specimens from healthy individuals and detected low rates of invalid (0.3%) and false-positive (<0.05%) results. We demonstrate that saliva is a valid alternative to swabs for SARS-CoV-2 screening and that SalivaDirect can make large-scale testing more accessible and affordable. Uniquely, we can designate other laboratories to use our sensitive, flexible, and simplified platform under our EUA (https://publichealth.yale.edu/salivadirect/). This study was funded by the NBA and NBPA (N.D.G.), the Huffman Family Donor Advised Fund (N.D.G.), a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (N.D.G.), the Yale Institute for Global Health (N.D.G.), and the Beatrice Kleinberg Neuwirth Fund (A.I.K.). C.B.F.V. is supported by NWO Rubicon 019.181EN.004. Frequent testing is critical to limit SARS-CoV-2 transmission. In response to this need, we developed SalivaDirect, a sensitive, simplified, and flexible testing framework, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). We tested saliva collected from a hospital cohort and showed a high positive agreement (94%) as compared to paired nasopharyngeal swabs tested with a commercial diagnostic kit. Then, we partnered with the National Basketball Association (NBA) to test a large cohort of mostly healthy individuals, and we detected low rates of invalid (0.3%) and false-positive (0.03%–0.05%) results. Our study shows that SalivaDirect can help to increase testing capacity by providing access to an affordable framework that is less prone to supply chain shortages. SalivaDirect is a sensitive saliva-based COVID-19 diagnostic test, which received Emergency Use Authorization from the U.S. FDA. With the ability to designate other laboratories, the flexible and simplified framework helps to increase the capacity of existing laboratory infrastructure for SARS-CoV-2 testing.
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