Kyosei Yuta, Yamura Sou, Namba Mayuri, Yoshimura Teruki, Watabe Satoshi, Ito Etsuro
Department of Biology, Waseda University, Shinjuku, Tokyo 162-8480, Japan.
School of Pharmaceutical Sciences, Health Sciences University of Hokkaido, Ishikari, Hokkaido 061-0293, Japan.
Biophys Physicobiol. 2021 Feb 10;18:28-39. doi: 10.2142/biophysico.bppb-v18.004. eCollection 2021.
PCR diagnosis has been considered as the gold standard for coronavirus disease 2019 (COVID-19) and other many diseases. However, there are many problems in using PCR, such as non-specific (i.e., false-positive) and false-negative amplifications, the limits of a target sample volume, deactivation of the enzymes used, complicated techniques, difficulty in designing probe sequences, and the expense. We, thus, need an alternative to PCR, for example an ultrasensitive antigen test. In the present review, we summarize the following three topics. (1) The problems of PCR are outlined. (2) The antigen tests are surveyed in the literature that was published in 2020, and their pros and cons are discussed for commercially available antigen tests. (3) Our own antigen test on the basis of an ultrasensitive enzyme-linked immunosorbent assay (ELISA) is introduced. Finally, we discuss the possibility that our antigen test by an ultrasensitive ELISA technique will become the gold standard for diagnosis of COVID-19 and other diseases.
聚合酶链反应（PCR）诊断已被视为2019冠状病毒病（COVID-19）及其他多种疾病的金标准。然而，PCR的使用存在许多问题，如非特异性（即假阳性）和假阴性扩增、目标样本量的限制、所用酶的失活、技术复杂、探针序列设计困难以及费用高昂。因此，我们需要一种替代PCR的方法，例如超灵敏抗原检测。在本综述中，我们总结了以下三个主题。（1）概述了PCR的问题。（2）对2020年发表的文献中的抗原检测进行了调查，并讨论了市售抗原检测的优缺点。（3）介绍了我们基于超灵敏酶联免疫吸附测定（ELISA）的抗原检测方法。最后，我们讨论了通过超灵敏ELISA技术进行的抗原检测成为COVID-19及其他疾病诊断金标准的可能性。
