Analysis COVID Variants 500 virions per mL v1.0.

The COVID-19 (SARS-CoV-2) pandemic has led to a significant mortality globally and persistent health challenges in many survivors. Early accurate diagnosis, surveillance, identification of cohorts, and prophylaxis are considered essential measures to reduce the spread of infectious viral pathogens such as SARS-CoV-2. A reliable, fast, high-throughput screening method that can detect viral particles and identify the pathogenic virus in infected individuals could help to reduce the spread of the next viral threat through quick knowledge and implementation of appropriate prevention strategies. Since respiratory viruses are typically present in nasal and oral secretions, saliva is a good target for testing for viral infections. Saliva testing has slowly gained popularity in the diagnostics based on biomarkers and other constituents ranging from organic compounds (e.g., food additives), peptides, and even microorganisms. Polymerase chain reaction (PCR) remains the gold standard for sensitive detection of SARS-CoV-2 infection in biological samples. However, while PCR testing for COVID is sensitive and widely used by hospitals, the method has a false-negative rate of 15–20% and is kit-based necessitating the development of alternative methods of detection that provide higher accuracy. This paper describes the use of a SpecID Mass Spectrometer that can detect the presence of viral particles in saliva at very low levels (<500 virions/0.5 ml). The main goal of this study was to demonstrate that our previously developed, portable, mass spectrometry based method, SpecID, could also be sued for detecting viruses in saliva, including but not limited to SARS-CoV-2; the SpecID method has the potential to provide a reliable solution that overcomes some of the challenges with molecular testing like PCR.

新型冠状病毒肺炎（COVID-19，病原体为SARS-CoV-2）大流行已在全球范围内造成大量死亡，并为众多幸存者带来持续的健康难题。早期精准诊断、疫情监测、队列识别与预防措施，被视为遏制SARS-CoV-2等传染性病毒病原体传播的关键手段。可靠、快速且高通量的筛查方法，可在感染者体内检测病毒颗粒并鉴定致病病毒，通过快速获取检测结果并落实恰当的防控策略，助力降低下一次病毒威胁的传播风险。由于呼吸道病毒通常存在于鼻腔与口腔分泌物中，唾液成为病毒感染检测的理想样本类型。基于生物标志物及其他成分（如有机化合物、食品添加剂、肽类乃至微生物）的唾液检测技术，正逐步在诊断领域获得认可与应用。聚合酶链式反应（Polymerase chain reaction，PCR）仍是生物样本中SARS-CoV-2感染高灵敏度检测的金标准。然而，尽管新冠PCR检测灵敏度高且被医院广泛采用，该方法的假阴性率达15%至20%，且依赖检测试剂盒，因此亟需开发准确性更高的替代检测手段。本研究介绍了一款SpecID质谱仪的应用，该设备可在极低浓度下（<500个病毒颗粒/0.5毫升）于唾液样本中检测病毒颗粒的存在。本研究的核心目标是验证：我们此前开发的基于质谱技术的便携式检测方法SpecID，同样可用于唾液样本中的病毒检测，检测范围涵盖（但不限于）SARS-CoV-2；该SpecID方法有望提供可靠的解决方案，破解聚合酶链式反应等分子检测技术面临的部分难题。