Department of Pathology, Baylor Scott and White Health, Temple, Texas, United States of America.
Health Texas Provider Network, Baylor Scott and White Health, Dallas, Texas, United States of America.
PLoS One. 2020 Oct 6;15(10):e0240076. doi: 10.1371/journal.pone.0240076. eCollection 2020.
Public health emergency of SARS-CoV-2 has facilitated diagnostic testing as a related medical countermeasure against COVID-19 outbreak. Numerous serologic antibody tests have become available through an expedited federal emergency use only process. This paper highlights the analytical characteristic of an ELISA based assay by AnshLabs and three random access immunoassay (RAIA) by DiaSorin, Roche, and Abbott that have been approved for emergency use authorization (EUA), at a tertiary academic center in a low disease-prevalence area. The AnshLabs gave higher estimates of sero-prevalence, over the three RAIA methods. For positive results, AnshLabs had 93.3% and 100% agreement with DiaSorin or Abbott and Roche respectively. For negative results, AnshLabs had 74.3% and 78.3% agreement with DiaSorin and Roche or Abbott respectively. All discrepant samples that were positive by AnshLabs and negative by RAIA tested positive by all-in-one step SARS-CoV-2 Total (COV2T) assay performed on the automated Siemens Advia Centaur XPT analyzer. None of these methods, however, are useful in early diagnosis of SARS-CoV-2.
SARS-CoV-2 引发的公共卫生紧急事件促进了诊断检测,成为应对 COVID-19 疫情的相关医疗对策。通过加速的联邦紧急使用授权(EUA)程序,许多血清学抗体检测已经可用于临床。本文在低发病地区的一家三级学术中心,重点介绍了 AnshLabs 的基于 ELISA 的检测和 DiaSorin、罗氏和雅培的三种随机访问免疫分析(RAIA)的分析特性,这三种方法均已获得 EUA 批准。与三种 RAIA 方法相比,AnshLabs 对血清阳性率的估计更高。对于阳性结果,AnshLabs 与 DiaSorin 或罗氏和雅培的符合率分别为 93.3%和 100%。对于阴性结果,AnshLabs 与 DiaSorin 和罗氏或雅培的符合率分别为 74.3%和 78.3%。所有由 AnshLabs 检测为阳性而由 RAIA 检测为阴性的差异样本,均由在自动化 Siemens Advia Centaur XPT 分析仪上进行的一步法 SARS-CoV-2 总抗体(COV2T)检测阳性。然而,这些方法均无法用于 SARS-CoV-2 的早期诊断。