STTR Phase I: A system for collection, transportation and accurate analysis of RNA virus specimens

STTR一期：RNA病毒标本采集、运输和准确分析系统

• 批准号: 2051967
• 负责人: Avinoam Dukler
• 金额: $ 25.6万
• 依托单位: Kepler Diagnostics Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2051967&HistoricalAwards=false
• 关键词: STTR; Phase; system; collection; transportation

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to support a testing device for collection, transportation and diagnosis of certain viral infections, such as hepatitis C virus (HCV), human immunodeficiency virus (HIV) and measles. Recent viral outbreaks of measles, Ebola, Zika, SARS-CoV, and the COVID-19 pandemic have illustrated the need for fast and accurate diagnosis to contain the outbreak, as well as for decentralized testing during periods of quarantine or general global epidemiological surveillance. The technology will enable at-home or remote location specimen collection without the need for traditional, costly, draw stations and overnight cold-pack shipments. The initial target is hepatitis C virus (HCV) infections. The United States Centers for Disease Control and Prevention (CDC) recommend that adults should be screened for HCV infection at least once in their lifetimes, and women should be screened during each pregnancy. This Small Business Technology Transfer (STTR) Phase I project will focus on solving the inherent instability of RNA viruses. RNA viruses, in liquid blood and especially dry, degrade rapidly. It is why SARS-COV-2 is primarily a contact/aerosol transmission and not a problem with packages. RNA samples have a high sensitivity to ribonucleases (enzymes that catalyze the degradation of RNA) and degrade in a short period of time when dried. Thiis project will create a special protective environment so that when the specimen dries it does not degrade; it will consist of a device that retains a fixed and known amount of specimen, desiccant for drying, and modified atmospheric packaging (MAP) preventing specimen degradation at ambient temperature for up to 14 days. The MAP prevents gas exchange during transit, enabling collection and transport in any weather conditions including cold, heat, and high humidity. Upon arrival at the laboratory, an extraction process will recover the RNA virus for testing via RT-qPCR. This project will evaluate the impact of drying time, inhibition of ribonucleases, gas content within the MAP, transport media, extraction buffer, and RT-qPCR techniques to stabilize and quantify HCV.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这一小型企业技术转让(STTR)第一阶段项目的更广泛影响/商业潜力是支持一种测试设备，用于收集、运输和诊断某些病毒感染，如丙型肝炎病毒(丙型肝炎病毒)、人类免疫缺陷病毒(HIV)和麻疹。最近爆发的麻疹、埃博拉病毒、寨卡病毒、SARS冠状病毒和新冠肺炎大流行表明，需要快速和准确的诊断来控制疫情，以及在检疫或一般全球流行病学监测期间进行分散检测。这项技术将使在家中或远程收集标本成为可能，而不需要传统的、昂贵的抽样站和隔夜的冷包运输。最初的目标是丙型肝炎病毒(HCV)感染。美国疾病控制和预防中心(CDC)建议，成年人一生中至少应该进行一次丙型肝炎病毒感染筛查，女性应该在每次怀孕期间进行筛查。这个小型企业技术转移(STTR)第一阶段项目将专注于解决RNA病毒固有的不稳定性。RNA病毒，在液态血液中，尤其是干燥的血液中，会迅速降解。这就是为什么SARS-COV-2主要是一种接触/气溶胶传播，而不是包裹的问题。RNA样品对核糖核酸酶(催化RNA降解的酶)高度敏感，干燥后会在短时间内降解。该项目将创造一个特殊的保护环境，使样品在干燥时不会降解；它将包括一个保留固定和已知数量的样品的装置，用于干燥的干燥剂，以及可防止样品在常温下降解长达14天的改良常压包装(MAP)。该地图防止运输过程中的气体交换，使收集和运输能够在任何天气条件下进行，包括寒冷、炎热和高湿度。到达实验室后，提取过程将通过RT-qPCR回收RNA病毒进行检测。该项目将评估干燥时间、核糖核酸酶抑制、MAP内气体含量、运输介质、提取缓冲液和RT-qPCR技术对稳定和量化HCV的影响。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。