新型冠状病毒肺炎:实验室检测、治疗及疫苗

新型冠状病毒肺炎（2019 novel coronavirus disease, COVID-19），一种由动物来源的新型冠状病毒（severe acute respiratory syndrome coronavirus 2, SRAS-CoV-2）感染所致的疾病在全球范围内急速传播，严重的危害人类的健康。快速、准确的诊断，安全有效的治疗方案及疫苗的研发对控制新冠病毒的传播具有重要的意义。为控制新冠病毒的传播，全世界的科学家和研究者投入了极大的精力去开发、研制快速准确的诊断试剂，治疗方案和疫苗，并取得了较大的进展。目前，基于各种检测平台的诊断试剂已在临床实验室应用，多种治疗方案已应用于临床治疗并取得不错的治疗效果。快速准确的样本采集和实验室检测是COVID-19临床治疗及有效控制病毒传染的两大重要支撑。虽然在多种类型的样本中均检测出了新冠病毒，但上呼吸道和下呼吸道样本尤其是鼻咽拭子依旧是目前检测最多的样本类型。随着疫情的发展，大量的基于核酸扩增的分子检测试剂和基于抗原或抗体的快速检测试剂已被研发并商业化获批。目前，实时荧光定量PCR检测依旧是新冠病毒检测最常用的和被认为是“金标准”的方法。虽然较多标签外用药药物和同情治疗方案取得了一定的临床疗效或改善，但目前针对新型冠状病毒肺炎尚无有效的治疗方案。目前在研究中针对新冠病毒的疫苗主要有：灭活或减毒病毒疫苗、基于蛋白质的疫苗、载体疫苗及DNA和RNA疫苗等。在全球，已有47个疫苗进入临床评估阶段，其中，10个疫苗处于临床Ⅲ期试验。本文简要介绍了目前新冠病毒肺炎的实验室诊断、治疗方案及疫苗研制所取得的进展。

COVID-19: Laboratory Diagnosis,Therapeutics and Vaccines

Pandemic of 2019 novel coronavirus disease (COVID-19), caused by a new zoonotic coronavirus severe acute respiratory syndrome coronavirus 2 (SRAS-CoV-2), is an ongoing worldwide health emergency. Accurate and fast diagnostic tests, safety and effective therapeutics and vaccines are important interventions to control the COVID-19 outbreak. Scientists/researchers have been endeavoring to uncover the pathophysiology of disease, develop the new assays and the effective antiviral treatments and vaccines against the SRAS-CoV-2. Currently, various diagnostic tests for COVID-19 based on various methods are available and used in clinical laboratories, and several repurposing candidates agents or therapeutics for COVID-19 have shown efficacy. Rapid collection of appropriate specimens and accurate laboratory diagnosis of SARS-CoV-2 infection are the two priorities to support the COVID-19 clinical management and infection control measures. Although SARS-CoV-2 has been detected from various specimens, the upper and lower respiratory samples, especially nasopharyngeal and/or oropharyngeal swabs are still the most common sample types being tested. Lots of nucleic acid amplification tests (NAAT) and rapid diagnostic tests that detect the presence of SARS-CoV-2 viral protein (antigens) or antibodies to SARS-CoV-2 are being developed and commercialized. Wherever possible, suspected active SARS-CoV-2 infections should be tested with NAAT. To date, real-time quantification RT-PCR (rRT-PCR) is still the most common and “gold standard” for detection of SARS-CoV-2. Several off-label and compassionate therapies have been used in a large number patients, and some of them showed clinical benefits or improvement. But there are no specific effective antiviral therapies for SARS-CoV-2 yet. Multiple strategies have been adopting to develop vaccines for the prevention of COVID-19, several different types of potential vaccines for COVID-19 are in development, including inactivated or weakened virus vaccines, protein based vaccines, viral vector vaccines and RNA/DNA vaccines. The great progress has been made. 47 candidate vaccines are in clinical evaluation, among them, ten candidate vaccines are in phase III human clinical trials. And several vaccines show high immunogenicity in the phase I and phase II trials. Here, we reviewed the current laboratory diagnosis methods including the specimen collection, and the ongoing advances in developing therapeutic agents and vaccines of SRAS-CoV-2 infection, based on the available evidence.