Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
Connecticut Agricultural Experimental Station, State of Connecticut, New Haven, CT 06511, USA.
Med. 2021 Mar 12;2(3):263-280.e6. doi: 10.1016/j.medj.2020.12.010. Epub 2020 Dec 26.
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.
为了满足安全重新开放的需求，将 SARS-CoV-2 检测扩大规模仍然受到检测成本和供应链短缺的困扰。为此，我们开发了 SalivaDirect，该检测已获得美国食品和药物管理局（FDA）的紧急使用授权（EUA）。
我们通过以下方式简化了基于唾液的诊断测试：（1）不要求使用含防腐剂的采集管；（2）用简单的酶和加热步骤代替核酸提取；（3）使用双重 qRT-PCR 检测方法检测样本。此外，我们使用来自多个供应商的试剂和仪器验证了 SalivaDirect，以尽量减少供应链问题。
从我们的医院队列中，我们发现使用 SalivaDirect 检测的唾液与使用商业 qRT-PCR 试剂盒检测的鼻咽拭子之间具有很高的阳性一致性（94%）。与美国国家篮球协会（NBA）和美国国家篮球运动员协会（NBPA）合作，我们对 3779 名健康个体的唾液样本进行了检测，发现无效（0.3%）和假阳性（<0.05%）的结果率很低。
我们证明唾液是 SARS-CoV-2 筛查的一种有效替代拭子的方法，并且 SalivaDirect 可以使大规模检测更易于获得和负担得起。我们的独特之处在于，我们可以根据我们的 EUA 授权其他实验室使用我们灵敏、灵活和简化的平台（https://publichealth.yale.edu/salivadirect/
本研究由 NBA 和 NBPA（N.D.G.）、Huffman 家族捐赠顾问基金（N.D.G.）、乔治梅森大学 Mercatus 中心紧急创业基金（N.D.G.）、耶鲁全球健康研究所（N.D.G.）和 Beatrice Kleinberg Neuwirth 基金（A.I.K.）资助。C.B.F.V. 得到了 NWO Rubicon 019.181EN.004 的支持。
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