Shafie Muhammad Hakimin, Antony Dass Marie, Ahmad Shaberi Hazlam Shamin, Zafarina Zainuddin
Analytical Biochemistry Research Centre (ABrC), Bangunan Inkubator Inovasi Universiti (I2U), Kampus Sains@usm, Universiti Sains Malaysia, Lebuh Bukit Jambul, 11900 Bayan Lepas, Penang Malaysia.
School of Life and Environmental Sciences, Deakin University, Waurn Ponds, Geelong, 3216 Australia.
Beni Suef Univ J Basic Appl Sci. 2023;12(1):6. doi: 10.1186/s43088-023-00342-3. Epub 2023 Jan 11.
Coronavirus disease 2019 is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection that emerged in late 2019 and has activated an ongoing international public health emergency. SARS-CoV-2 was discovered in Wuhan, China, in December 2019 and rapidly spread to other cities and countries. Currently, SARS-CoV-2 diagnostic tests have relied heavily on detecting viral genes, antigens, and human antibodies. Hence, this review discusses and analyses the existing screening and confirmation tests for SARS-CoV-2, including the real-time reverse transcriptase polymerase chain reaction (RT-PCR), lateral flow immunoassay (LFIA), and enzyme-linked immunosorbent assay (ELISA).
The illustrations of each testing were presented to provide the readers with an understanding of the scientific principles behind the testing methods. The comparison was made by highlighting the advantages and disadvantages of each testing. ELISA is ideal for performing the maximum population screening to determine immunological capacity, although its inability to provide reliable results on the status of the infection. Recently, LFIA has been approved as a quicker way of determining whether a patient is infected at the analysis time without using particular instruments and non-laboratory settings. RT-PCR is the gold-standard approach in terms of sensitivity and specificity.
However, the combination of LFIA or ELISA with RT-PCR is also proposed in this review to obtain an adequate level of sensitivity and specificity.
2019冠状病毒病是由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染引起的大流行病，于2019年末出现并引发了持续的国际公共卫生紧急事件。SARS-CoV-2于2019年12月在中国武汉被发现，并迅速传播到其他城市和国家。目前，SARS-CoV-2诊断测试严重依赖于检测病毒基因、抗原和人体抗体。因此，本综述讨论并分析了现有的SARS-CoV-2筛查和确认测试，包括实时逆转录聚合酶链反应（RT-PCR）、侧向流动免疫分析（LFIA）和酶联免疫吸附测定（ELISA）。
展示了每种测试的图示，以使读者了解测试方法背后的科学原理。通过突出每种测试的优缺点进行了比较。ELISA非常适合进行最大规模的人群筛查以确定免疫能力，尽管它无法提供关于感染状态的可靠结果。最近，LFIA已被批准为一种在分析时无需使用特定仪器且在非实验室环境下就能更快确定患者是否感染的方法。RT-PCR在灵敏度和特异性方面是金标准方法。
然而，本综述也提出将LFIA或ELISA与RT-PCR结合使用，以获得足够的灵敏度和特异性水平。
