Improved diagnostic sensitivity for rapid COVID-19 testing using Enhanced Preservation Media

项目摘要 COVID-19仍然是一个全球紧急情况。随着国家和经济试图重新开放， 病毒传播和死亡率继续上升，特别是在许多大城市中心， 在美国，收容所的订单并没有充分减少感染负担。 继续改善SARS-CoV-2检测基础设施和检测性能是当务之急 needed.据报道，假阴性检测率为30- 50%，这意味着每10 COVID-19阳性患者检测，3至5人将获得不准确的阴性结果。这些虚假 目前使用的所有检测平台均出现阴性率， 几乎不可能虽然测试系统本身的技术在技术上是 非常敏感，大部分损失的灵敏度出现在测试过程的早期， 收集、运输和RNA提取。 全球高假阴性检测结果率-使用最好的检测试剂盒和方案- 继续产生的两个主要来源：第一，样本没有很好地保存在CDC认可的 病毒转运培养基/通用转运培养基（VTM/UTM）或其他转运培养基， 由于保存不佳，导致10- 100倍的信号损失;第二，剩余的 然后在提取过程中将样品进一步稀释至原始浓度的0.25 在进入测试之前。除非这些基本的测试问题得到解决，否则 如果没有解决方案，高假阴性检测结果将使病毒传播继续上升。在 为了解决这一未满足的需求，Convergent Genomics开发了增强保存技术， Media™是一种通用的样本运输和集成提取解决方案， 提高测试性能。 增强型保存介质（Enhanced Preservation Media，简称EMPT）可实现以下测试改进： 专为与全球范围内的床旁或集中PCR检测无缝集成而构建; 将获得FDA批准，成为第一个集成稳定和提取保存介质 用于SARS-CoV-2;和将与领先的研究中心进行临床验证， 扩大SARS-CoV-2的社区监测测试。我们专有的缓冲区保护免费 核酸通过多种机制，破坏病毒以保护检测人员， 整个样品的简单、高通量提取。体外试验表明， 该平台的功能，以显着提高测试性能，在最具挑战性的 低病毒载量样本。

Project Summary COVID-19 continues to be a global emergency. As nations and economies attempt to reopen, the rate of viral spread and deaths continues to rise, particularly in many large urban centers within the United States, where shelter in place orders did not sufficiently reduce infection burden. Continued improvement in SARS-CoV-2 testing infrastructure and test performance are urgently needed. False negative testing rates have been reported at 30-50%, meaning that for every 10 COVID-19 positive patients tested, 3 to 5 will receive an inaccurate negative result. These false negative rates occur with all testing platforms currently used, making control of viral spread nearly impossible. While the technology underlying the test systems themselves are technically very sensitive, much of the lost sensitivity arises earlier in the test process during sample collection, transportation, and RNA extraction. Global rates of high false negative test results – using the best test kits and protocols – continue to arise from two major sources: First, samples are not well preserved in CDC endorsed Viral Transport Media/Universal Transport Media (VTM/UTM) or other transport medias, leading to a 10-100x signal loss as a consequence of poor preservation; Second, the remaining sample is then further diluted often to 0.25% of the original concentration during extraction before going into the test. Until these fundamental testing problems are solved, and with no other solutions available, high false negative test results will allow viral spread to continue rising. In order to address this unmet need, Convergent Genomics has developed Enhanced Preservation Media™, a universal specimen transportation and integrated extraction solution, to significantly improve testing performance. Enhanced Preservation Media (EPM) enables the following testing improvements: EPM is built for seamless integration with point-of-care or centralized PCR tests world-wide; EPM will achieve FDA approval as the first integrated stabilization and extraction preservation media for SARS-CoV-2; and EPM will be clinically validated with leading research centers for expanded community surveillance testing of SARS-CoV-2. Our proprietary buffer protects free nucleic acids by multiple mechanisms, destroys virus to protect testing personnel, and facilitates simple, high-throughput extraction of entire samples. In vitro testing has demonstrated the capabilities of this platform to significantly improve testing performance in the most challenging low viral load samples.