Review of Current COVID-19 Diagnostics and Opportunities for Further Development.
Review of Current COVID-19 Diagnostics and Opportunities for Further Development.
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当前 COVID-19 诊断的回顾和进一步发展的机会。
DOI：
10.3389/fmed.2021.615099
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发表时间：
2021
影响因子：
3.9
通讯作者：
Lau CY
中科院分区：
文献类型：
--
作者：
Mardian Y;Kosasih H;Karyana M;Neal A;Lau CY
诊断检测在应对由严重急性呼吸系统综合征冠状病毒2型（SARS-CoV-2）引起的2019年冠状病毒病（COVID-19）大流行方面发挥着关键作用。快速准确的诊断检测对于识别和管理感染者、接触者追踪、流行病学特征描述和公共卫生决策至关重要。实验室检测可以根据症状表现或无症状人群的筛查进行。SARS-CoV-2感染的确认通常通过核酸扩增测试（NAAT）进行，这需要专门的设备和培训，在资源有限的环境中可能特别具有挑战性。NAAT可能由于样本采集相对于感染的时间、呼吸道样本采样不当、样本保存不充分和技术限制而产生假阴性结果;假阳性可能由于技术错误而发生，特别是手动实时聚合酶链反应（RT-PCR）过程中的污染。因此，在解释结果时，必须考虑临床表现、接触史和当代流行病学。已经开发了几种样品到答案平台，包括高通量系统和护理点（Point of Care，简称PART）检测，以提高检测能力并减少技术错误。RT-PCR检测的替代方法，如其他RNA检测方法和抗原检测可能适用于某些情况，如资源有限的环境。虽然测序对监测SARS-CoV-2基因组的持续进化很重要，但抗体测定可用于流行病学目的。不断扩大的各种测试，具有不同的临床效用，性能要求和局限性，值得比较评估。我们在此对目前可用的COVID-19诊断方法进行全面回顾，探讨其优缺点以及适当的适应症。提出了进一步优化SARS-CoV-2检测的安全性、速度和简便性而不影响准确性的策略。获得可扩展的诊断工具和持续的技术进步，包括机器学习和智能手机集成，将有助于控制当前的流行病以及为下一次流行病做好准备。
Diagnostic testing plays a critical role in addressing the coronavirus disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Rapid and accurate diagnostic tests are imperative for identifying and managing infected individuals, contact tracing, epidemiologic characterization, and public health decision making. Laboratory testing may be performed based on symptomatic presentation or for screening of asymptomatic people. Confirmation of SARS-CoV-2 infection is typically by nucleic acid amplification tests (NAAT), which requires specialized equipment and training and may be particularly challenging in resource-limited settings. NAAT may give false-negative results due to timing of sample collection relative to infection, improper sampling of respiratory specimens, inadequate preservation of samples, and technical limitations; false-positives may occur due to technical errors, particularly contamination during the manual real-time polymerase chain reaction (RT-PCR) process. Thus, clinical presentation, contact history and contemporary phyloepidemiology must be considered when interpreting results. Several sample-to-answer platforms, including high-throughput systems and Point of Care (PoC) assays, have been developed to increase testing capacity and decrease technical errors. Alternatives to RT-PCR assay, such as other RNA detection methods and antigen tests may be appropriate for certain situations, such as resource-limited settings. While sequencing is important to monitor on-going evolution of the SARS-CoV-2 genome, antibody assays are useful for epidemiologic purposes. The ever-expanding assortment of tests, with varying clinical utility, performance requirements, and limitations, merits comparative evaluation. We herein provide a comprehensive review of currently available COVID-19 diagnostics, exploring their pros and cons as well as appropriate indications. Strategies to further optimize safety, speed, and ease of SARS-CoV-2 testing without compromising accuracy are suggested. Access to scalable diagnostic tools and continued technologic advances, including machine learning and smartphone integration, will facilitate control of the current pandemic as well as preparedness for the next one.