Premraj Avinash, Aleyas Abi George, Nautiyal Binita, Rasool Thaha J
Camel Biotechnology Center, Presidential Camels and Camel Racing Affairs Centre, Department of the President's Affairs, P O Box 17292, Al Ain 17292, UAE.
Diagnostics (Basel). 2020 Oct 23;10(11):866. doi: 10.3390/diagnostics10110866.
Accurate diagnosis at an early stage of infection is essential for the successful management of any contagious disease. The coronavirus disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus is a pandemic that has affected 214 countries affecting more than 37.4 million people causing 1.07 million deaths as of the second week of October 2020. The primary diagnosis of the infection is done either by the molecular technique of RT-qPCR by detecting portions of the RNA of the viral genome or through immunodiagnostic tests by detecting the viral proteins or the antibodies produced by the host. As the demand for the test increased rapidly many naive manufacturers entered the market with novel kits and more and more laboratories also entered the diagnostic arena making the test result more error-prone. There are serious debates globally and regionally on the sensitivity and specificity of these tests and about the overall accuracy and reliability of the tests for decision making on control strategies. The significance of the test is also complexed by the presence of asymptomatic carriers, re-occurrence of infection in cured patients as well as by the varied incubation periods of the infection and shifting of the viral location in the host tissues. In this paper, we review the techniques available for SARS-CoV-2 diagnosis and probable factors that can reduce the sensitivity and specificity of the different test methods currently in vogue. We also provide a checklist of factors to be considered to avoid fallacious practices to reduce false positive and false negative results by the clinical laboratories.
对于任何传染病的成功管理而言,在感染早期进行准确诊断至关重要。2019冠状病毒病(COVID-19)由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起,是一场大流行疾病,截至2020年10月的第二周,已影响214个国家,感染人数超过3740万,导致107万人死亡。该感染的主要诊断方法,要么是通过逆转录定量聚合酶链反应(RT-qPCR)的分子技术检测病毒基因组的RNA部分,要么是通过免疫诊断测试检测病毒蛋白或宿主产生的抗体。随着检测需求迅速增加,许多缺乏经验的制造商带着新型试剂盒进入市场,越来越多的实验室也进入诊断领域,这使得检测结果更容易出错。全球和地区都在就这些检测的敏感性和特异性以及检测在控制策略决策方面的整体准确性和可靠性展开激烈辩论。无症状携带者的存在、治愈患者感染的复发、感染潜伏期的不同以及病毒在宿主组织中位置的变化,也使检测的意义变得复杂。在本文中,我们回顾了可用于SARS-CoV-2诊断的技术以及可能降低当前流行的不同检测方法的敏感性和特异性的因素。我们还提供了一份因素清单,供临床实验室考虑,以避免错误做法,减少假阳性和假阴性结果。