Evaluations of serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak

Dachuan Lin; Lei Liu; Mingxia Zhang; Yunlong Hu; Qianting Yang; Jiubiao Guo; Youchao Dai; Yuzhong Xu; Yi Cai; Xinchun Chen; Kaisong Huang; Zheng Zhang

is the (which was not peer-reviewed) The copyright holder for this preprint . https: //doi.org/10.1101 //doi.org/10. /2020 four genera, namely Alphacoronavirus , Betacoronavirus, Gammacoronavirus, and Deltacoronavirus 44 (4). Prior to December 2019, a total of six coronaviruses have been documented to be capable of 45 causing disease in humans. These include two strains from Alphacoronavirus (HCoV-229E and HKU-46 NL63) and four from Betacoronavirus subfamily (HCoV-OC43, HCoV-HKU1, SARS-CoV and MERS-CoV) 47 (5-10). Among them, the Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and Middle East 48 Respiratory Syndrome coronavirus (MERS-CoV) are the most well-described as they directly led to two 49 deadly large-scale outbreaks globally, with 8,096 cases infections and roughly 10 percent mortality 50 and 2,494 cases and 34.4 percent mortality, respectively(9, 10). 51 Recently, the outbreak of a severe pneumonia COVID-19 was confirmed to be caused by the 2019 52 novel coronavirus infections (SARS-CoV-2) that was originated from a seafood wholesale market in 53 Wuhan, China(11). So far, this novel coronavirus has spread throughout the whole of China and over 54 198 countries globally, causing over468,905 laboratory-confirmed cases of infections with 21,200 55 people dead posing a great threat to the global public health (http://2019ncov.chinacdc.cn/2019-nCov/). 56 Besides, there are still numerous suspected cases and a myriad of medical monitoring people who 57 were quarantined in specialized hospitals or at homes because of their previous epidemiological link 58 to confirmed SARS-CoV-2 patients. All of these put an extreme burden on the emergency, hospital 59 and public health system particularly the epidemic zone worldwide. Therefore, a timely, sensitive and 60 accurate diagnosis approach is urgently needed and of pivotal importance for surveillances of disease 61 dissemination and the prevention of further expansions. Conventional diagnosis methods such as 62 virus culture and microscopic analysis are generally time-consuming and labor-intensive with limited 63 sensitivity (12, 13). In contrast, the last decade emerged molecular biologic and serologic approaches, 64 . CC-BY-NC 4.0 International license It is made available under a author/funder, who has granted medRxiv a license to display the preprint in perpetuity.